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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00738881
Other study ID # NCI-2009-00663
Secondary ID NCI-2009-00663CD
Status Terminated
Phase Phase 3
First received August 20, 2008
Last updated October 6, 2015
Start date October 2008
Est. completion date December 2014

Study information

Verified date December 2014
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This randomized phase III trial studies pemetrexed disodium to see how well it works compared with erlotinib hydrochloride as second-line therapy in treating patients with non-small cell lung cancer that has spread to other places in the body. Pemetrexed disodium and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed disodium is more effective than erlotinib hydrochloride in treating advanced non-small cell lung cancer.


Description:

PRIMARY OBJECTIVES:

I. To evaluate whether there are differences in progression-free survival due to treatment with erlotinib (erlotinib hydrochloride) compared to pemetrexed (pemetrexed disodium) for subsets of previously treated non-small cell lung cancer (NSCLC) patients defined by epidermal growth factor receptor (EGFR)-fluorescent in situ hybridization (FISH) positive versus negativity.

SECONDARY OBJECTIVES:

I. Ascertain the presence or absence of true differences due to treatment in the objective clinical endpoints of overall survival, confirmed response rate, and adverse event profile for subsets of patients defined on the basis of the epidermal growth factor receptor (EGFR)-FISH positivity versus negativity.

II. Ascertain the presence or absence of true differences due to treatment in objective clinical endpoints (i.e., progression free survival, overall survival, confirmed response rate, and adverse event profile) for subsets of patients defined on the basis of the epidermal growth factor receptor (EGFR) expression as measured by immunohistochemistry (IHC).

III. Ascertain the presence or absence of true differences due to treatment in objective clinical endpoints (i.e., progression free survival, overall survival, confirmed response rate, and adverse event profile) for subsets of patients defined on the basis of the epidermal growth factor receptor (EGFR) gene mutation status (MUT).

IV. To evaluate the prognostic effect of EGFR copy number as measured by FISH separately by treatment arm, i.e., is there a difference in outcome for FISH(+) patients receiving erlotinib compared to FISH (-) patients receiving erlotinib, and similarly is there a difference in outcome for FISH(+) patients receiving pemetrexed compared to FISH (-) patients receiving pemetrexed.

V. To evaluate the prognostic effect of EGFR expression as measured by IHC separately by treatment arm, i.e., is there a difference in outcome for IHC(+) patients receiving erlotinib compared to IHC (-) patients receiving erlotinib, and similarly is there a difference in outcome for IHC(+) patients receiving pemetrexed compared to IHC (-)patients receiving pemetrexed.

VI. To evaluate the prognostic effect of EGFR mutation status separately by treatment arm, i.e., is there a difference in outcome for MUT(+) patients receiving erlotinib compared to MUT(-) patients receiving erlotinib, and similarly is there a difference in outcome for MUT(+) patients receiving pemetrexed compared to MUT(-) patients receiving pemetrexed.

VII. To prospectively test the hypothesis that functionally relevant polymorphisms in the genes encoding for pemetrexed targets, as well as genes encoding for one or more of the key enzymes involved in the transport, activation, and inactivation of pemetrexed, either singly or in combination, play a role in the efficacy and/or toxicity of pemetrexed.

VIII. To prospectively test the hypothesis that functionally relevant polymorphisms in the EGFR gene as well as genes encoding for one or more of the key enzymes involved in the metabolism of erlotinib, either singly or in combination, play a role in the efficacy and/or toxicity of erlotinib.

IX. Evaluate proteomic signatures in blood samples as predictors of survival and response to treatment with erlotinib.

X. To evaluate expression of thymidylate synthase, dihydrofolate reductase, phosphoribosylglycineamide (GAR) formyltransferase, and methylthioadenosine phosphorylase gene expression in tumor samples, as measured by IHC or quantitative polymerase chain reaction, as predictors of survival and response to treatment with pemetrexed.

XI. To evaluate proteomic signatures in blood samples of patients as predictors of response and survival to treatment with erlotinib.

XII. To evaluate the following variables measured in tumor samples, as predictors of response and survival to treatment with pemetrexed: Expression of thymidylate synthase, dihydrofolate reductase and GAR formyltransferase genes methylthioadenosine phosphorylase expression by IHC or quantitative polymerase chain reaction (PCR).

XIII. To evaluate the following variables measured in tumor samples, as predictors of response and survival to treatment with erlotinib: Rat sarcoma (Ras) mutational status, EGFR mutational status and, epithelial to mesenchymal transition (EMT) status (measured by E-cadherin expression and vimentin expression) by IHC.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive pemetrexed disodium intravenously (IV) over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.


Recruitment information / eligibility

Status Terminated
Enrollment 23
Est. completion date December 2014
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Documented recurrence or disease progression of NSCLC

- NSCLC must be confirmed by pathologic examination, either on initial diagnosis or disease recurrence/progression; mixed histology allowed if all components consistent with NSCLC

- Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm by conventional techniques or as >= 1.0 cm by spiral computed tomography (CT); if spiral CT is used, it must be used for both pre- and post- treatment tumor assessments

- Prior radiation therapy is permitted as long as:

- Recovered from the toxic effects of radiation treatment before study entry, except for alopecia

- =< 25% of bone marrow radiated

- Presence of measurable disease whether in-field disease progression/recurrence or disease outside the treatment fields of radiation port

- Absolute neutrophil count (ANC) >= 1,500 uL

- Platelet (PLT) >= 100,000 uL

- Hemoglobin (Hgb) >= 10 g/dL

- Total bilirubin: within normal institutional limits (WNL) OR direct bilirubin =< upper limit of normal (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN

- International normalized ratio (INR) =< 1.5

- Calculated creatinine clearance >= 45 mL/min using the Cockcroft-Gault formula

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

- Negative pregnancy test done =< 7 days prior to pre-registration, for women of childbearing potential only

- Ability to provide informed consent

- Life expectancy >= 12 weeks

- Tissue available and willing to submit tissue for central pathology review and EGFR evaluation; performed on original diagnostic/recurrent tissue (preferably paraffin-embedded tissue blocks); if institution unable to release tissue blocks, willing to submit 25 unstained slides (15 sections cut at 5 microns mounted on charged slides and 10 sections cut at 10 microns mounted on uncharged slides)

- Must be previously treated for advanced disease with only 1 chemotherapy regimen which must contain cytotoxic agent(s); adjuvant/neoadjuvant treatment with cytotoxic agent(s) administered < 12 months (from date chemotherapy was started) prior to pre-registration will be considered as one prior treatment; NOTE: adjuvant/neoadjuvant treatment administered >= 12 months, use of targeted agents such as monoclonal antibodies prior to pre-registration will NOT be counted as one prior treatment; patient could have had adjuvant/neoadjuvant chemotherapy >= 12 months and 1 systemic chemotherapy regimen for metastatic or recurrent disease

- Able to take folic acid, vitamin B12 supplementation, and dexamethasone

- Able to permanently discontinue aspirin dose of >= 1.3 grams/day >= 10 days before and after pemetrexed treatment

- Fertile patients must use effective contraception

- Able to take folic acid, vitamin B_12 supplementation, and dexamethasone

- Stable brain metastasis that have been treated with either whole brain radiation therapy or gamma knife surgery and are off steroid treatment for > 14 days prior to pre-registration, if applicable

- Willingness to return to enrolling institution for treatment and follow-up

Exclusion Criteria:

- Any of the following:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate contraception

- Any clinically significant infection, at the treating physician's discretion

- Known human immunodeficiency virus (HIV) positive patients

- Impairment of gastrointestinal (GI) function, inability to swallow pills in the absence of a feeding tube, or GI disease that may significantly alter absorption of oral medications (e.g. ulcerative disease, uncontrolled nausea and vomiting, malabsorption syndromes, bowel obstruction, etc)

- Serious condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study or increase the risk for serious adverse events

- Any of the following prior therapies:

- Prior radiation to > 25% of bone marrow

- EGFR tyrosine kinase inhibitors

- Pemetrexed

- Chemotherapy =< 3 weeks prior to pre-registration

- Mitomycin C/nitrosoureas =< 6 weeks prior to pre-registration

- Immunotherapy =< 2 weeks prior to pre-registration

- Biologic therapy =< 2 weeks prior to pre-registration

- Gene therapy =< 2 weeks prior to pre-registration

- Full field radiation therapy =< 4 weeks prior to pre-registration

- Limited field radiation therapy =< 2 weeks prior to pre-registration

- Major surgery (i.e., laparotomy), open biopsy, or significant traumatic injury =< 4 weeks prior to pre-registration or anticipation of need for major surgical procedure during the course of the study; minor surgery =< 2 weeks prior to pre-registration; insertion of a vascular access device is not considered major or minor surgery in this regard

- Other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) =< 4 weeks prior to pre-registration

- Steroid therapy for brain metastasis =< 14 days prior to pre-registration

- Symptomatic serosal effusion (>= Common Terminology Criteria for Adverse Events [CTCAE] v3.0 grade 2 dyspnea) that is not amenable to drainage prior to pre-registration

- Other invasive solid or hematologic malignancy; exceptions: prior malignancy was diagnosed and definitively treated >= 5 years previously with no subsequent evidence of recurrence; patients with a history of low-grade (Gleason score =< 6) localized prostate cancer will be eligible even if diagnosed < 3 years prior to pre-registration; these patients may continue on medications concomitantly to maintain their disease remission as necessary; patients with carcinoma in situ, regardless of organ involvement, or non-melanoma cutaneous carcinomas are eligible if these were definitively treated >= 3 years previously with no subsequent evidence of recurrence; Note: patients with breast cancer that was definitively treated > 5 years earlier but continue to receive aromatase inhibitors are NOT eligible

- Only non-measurable disease, defined as all other lesions, including small lesions whose longest diameter measures < 2 cm with conventional techniques or < 1.0 cm with spiral CT, and truly non-measurable lesions, which include the following as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria dated June 1999:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Single disease site in prior radiation field

- Any of the following concurrent severe and/or uncontrolled medical conditions:

- Angina pectoris

- History of congestive heart failure =< 3 months prior to pre-registration, unless ejection fraction > 40%

- Myocardial infarction =< 6 months prior to pre-registration

- Cardiac arrhythmia

- Diabetes mellitus

- Hypertension

- Any other severe underlying diseases which are, in the judgment of the investigator, inappropriate for entry into this study

- Respiratory symptoms > CTCAE grade 1

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Erlotinib Hydrochloride
Given PO
Pemetrexed Disodium
Given IV

Locations

Country Name City State
Canada Allan Blair Cancer Centre Regina Saskatchewan
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa
United States AnMed Health Hospital Anderson South Carolina
United States Michigan Cancer Research Consortium CCOP Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Hospital District Sixth of Harper County Anthony Kansas
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States The Medical Center of Aurora Aurora Colorado
United States Greater Baltimore Medical Center Baltimore Maryland
United States Bronson Battle Creek Battle Creek Michigan
United States Franciscan St. Francis Health-Beech Grove Beech Grove Indiana
United States MacNeal Hospital and Cancer Center Berwyn Illinois
United States Hematology Oncology Associates-Quad Cities Bettendorf Iowa
United States Spectrum Health Big Rapids Hospital Big Rapids Michigan
United States Billings Clinic Cancer Center Billings Montana
United States Frontier Cancer Center and Blood Institute-Billings Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Mid Dakota Clinic Bismarck North Dakota
United States Saint Alexius Medical Center Bismarck North Dakota
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Boca Raton Comprehensive Cancer Center Boca Raton Florida
United States Lynn Regional Cancer Center - West Boca Raton Florida
United States Boston Medical Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States Bozeman Deaconess Hospital Bozeman Montana
United States Steward Saint Elizabeth's Medical Center Brighton Massachusetts
United States Bristol Hospital Bristol Connecticut
United States Roswell Park Cancer Institute Buffalo New York
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Graham Hospital Association Canton Illinois
United States Illinois CancerCare-Canton Canton Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Memorial Hospital Carthage Illinois
United States Rocky Mountain Oncology Casper Wyoming
United States Cedar Rapids Oncology Association Cedar Rapids Iowa
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Hematology and Oncology Associates Chicago Illinois
United States Northwestern University Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States North Coast Cancer Care-Clyde Clyde Ohio
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Danville Regional Medical Center Danville Virginia
United States Geisinger Medical Center Danville Pennsylvania
United States Genesis Medical Center - East Campus Davenport Iowa
United States Genesis Medical Center - West Campus Davenport Iowa
United States Dayton CCOP Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Samaritan North Health Center Dayton Ohio
United States Oakwood Hospital and Medical Center Dearborn Michigan
United States Decatur Memorial Hospital Decatur Illinois
United States Colorado Cancer Research Program CCOP Denver Colorado
United States Exempla Saint Joseph Hospital Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rose Medical Center Denver Colorado
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa Oncology Research Association CCOP Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Capitol Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Saint John Hospital and Medical Center Detroit Michigan
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Veterans Adminstration New Jersey Health Care System East Orange New Jersey
United States The Memorial Hospital at Easton Easton Maryland
United States Hematology Oncology Center Incorporated Elyria Ohio
United States Swedish Medical Center Englewood Colorado
United States Eureka Hospital Eureka Illinois
United States Illinois CancerCare-Eureka Eureka Illinois
United States Blanchard Valley Hospital Findlay Ohio
United States Hunterdon Medical Center Flemington New Jersey
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Sparks Regional Medical Center Fort Smith Arkansas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Kaiser Permanente-Fremont Fremont California
United States Galesburg Cottage Hospital Galesburg Illinois
United States Illinois CancerCare Galesburg Galesburg Illinois
United States Illinois CancerCare-Cottage Galesburg Illinois
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Altru Cancer Center Grand Forks North Dakota
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Grand Rapids Clinical Oncology Program Grand Rapids Michigan
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Berdeaux, Donald MD (UIA Investigator) Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Wayne Hospital Greenville Ohio
United States Illinois CancerCare-Havana Havana Illinois
United States Mason District Hospital Havana Illinois
United States Northern Montana Hospital Havre Montana
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Hematology Oncology Associates of Illinois-Highland Park Highland Park Illinois
United States Hopedale Medical Complex - Hospital Hopedale Illinois
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cape Cod Hospital Hyannis Massachusetts
United States Allegiance Health Jackson Michigan
United States Mayo Clinic in Florida Jacksonville Florida
United States Midwest Center for Hematology Oncology Joliet Illinois
United States Glacier Oncology PLLC Kalispell Montana
United States Kalispell Medical Oncology Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States North Kansas City Hospital Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Joseph Health Center Kansas City Missouri
United States Saint Luke's Cancer Institute Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States Truman Medical Center Kansas City Missouri
United States CHI Health Good Samaritan Kearney Nebraska
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Saint Anthony Hospital Lakewood Colorado
United States Sparrow Hospital Lansing Michigan
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Liberty Hospital Liberty Missouri
United States Liberty Radiation Oncology Center Liberty Missouri
United States NorthShore Hematology Oncology-Libertyville Libertyville Illinois
United States Lima Memorial Hospital Lima Ohio
United States Meeker County Memorial Hospital Litchfield Minnesota
United States Saint Mary Mercy Hospital Livonia Michigan
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States McKee Medical Center Loveland Colorado
United States Illinois CancerCare-Macomb Macomb Illinois
United States Mcdonough District Hospital Macomb Illinois
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Memorial Hospital Of Martinsville Martinsville Virginia
United States Fremont - Rideout Cancer Center Marysville California
United States Saint Luke's Hospital Maumee Ohio
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio
United States Loyola University Medical Center Maywood Illinois
United States Middlesex Hospital Middletown Connecticut
United States Hennepin County Medical Center Minneapolis Minnesota
United States Minnesota Cooperative Group Outreach Program Minneapolis Minnesota
United States Virginia Piper Cancer Institute Minneapolis Minnesota
United States Community Medical Hospital Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Holy Family Medical Center Monmouth Illinois
United States Illinois CancerCare-Monmouth Monmouth Illinois
United States Mercy Memorial Hospital Monroe Michigan
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly New Jersey
United States Mercy Health Mercy Campus Muskegon Michigan
United States DuPage Medical Group-Ogden Naperville Illinois
United States Illinois Cancer Specialists-Niles Niles Illinois
United States Bromenn Regional Medical Center Normal Illinois
United States Community Cancer Center Foundation Normal Illinois
United States Illinois CancerCare-Community Cancer Center Normal Illinois
United States Kaiser Permanente-Oakland Oakland California
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States Illinois CancerCare-Pekin Pekin Illinois
United States Pekin Cancer Treatment Center Pekin Illinois
United States Pekin Hospital Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Illinois Oncology Research Association CCOP Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Illinois Valley Hospital Peru Illinois
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Valley Care Health System - Pleasanton Pleasanton California
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Saint Joseph Mercy Port Huron Port Huron Michigan
United States Illinois CancerCare-Princeton Princeton Illinois
United States Perry Memorial Hospital Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Rapid City Regional Hospital Rapid City South Dakota
United States Riverview Medical Center/Booker Cancer Center Red Bank New Jersey
United States Kaiser Permanente-Redwood City Redwood City California
United States Kaiser Permanente-Richmond Richmond California
United States Reid Hospital and Health Care Services Richmond Indiana
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States University of Rochester Rochester New York
United States Cancer Trials Support Unit Rockville Maryland
United States Kaiser Permanente-Roseville Roseville California
United States Rutherford Hospital Rutherfordton North Carolina
United States Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Saint Mary's of Michigan Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Center for Cancer Care and Research Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis University Hospital Saint Louis Missouri
United States Regions Hospital Saint Paul Minnesota
United States Kaiser Permanente-San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser Permanente-San Rafael San Rafael California
United States North Coast Cancer Care Sandusky Ohio
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Mayo Clinic in Arizona Scottsdale Arizona
United States Mercy Hospital Scranton Pennsylvania
United States Scranton Hematology Oncology Scranton Pennsylvania
United States Shawnee Mission Medical Center-KCCC Shawnee Mission Kansas
United States Welch Cancer Center Sheridan Wyoming
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Hematology Oncology Associates of Illinois - Skokie Skokie Illinois
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Spartanburg Medical Center Spartanburg South Carolina
United States Illinois CancerCare-Spring Valley Spring Valley Illinois
United States Saint Margaret's Hospital Spring Valley Illinois
United States Memorial Medical Center Springfield Illinois
United States Geisinger Medical Group State College Pennsylvania
United States Mount Nittany Medical Center State College Pennsylvania
United States Kaiser Permanente-Stockton Stockton California
United States Flower Hospital Sylvania Ohio
United States State University of New York Upstate Medical University Syracuse New York
United States Syracuse Veterans Administration Medical Center Syracuse New York
United States North Suburban Medical Center Thornton Colorado
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Saint Anne Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States The Toledo Hospital/Toledo Children's Hospital Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Toledo Community Hospital Oncology Program CCOP Toledo Ohio
United States University of Toledo Toledo Ohio
United States Stormont-Vail Regional Health Center Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States Upper Valley Medical Center Troy Ohio
United States Tahoe Forest Cancer Center Truckee California
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
United States Virtua West Jersey Hospital Voorhees Voorhees New Jersey
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Covenant Medical Center Waterloo Iowa
United States Fulton County Health Center Wauseon Ohio
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Clinton Memorial Hospital Wilmington Ohio
United States Southeast Cancer Consortium-Upstate NCORP Winston-Salem North Carolina
United States Metro Health Hospital Wyoming Michigan
United States Greene Memorial Hospital Xenia Ohio

Sponsors (5)

Lead Sponsor Collaborator
National Cancer Institute (NCI) Canadian Cancer Trials Group, Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, Southwest Oncology Group

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival (PFS) Estimated using the method of Kaplan-Meier survival curves to compare PFS between the erlotinib and pemetrexed arms using an intent-to-treat (ITT) analysis. Due to the small sample size (21 of the required 954 patients ~2%), analyses within the FISH(+) and FISH(-) groups were not performed, and no formal analyses for the primary or the secondary efficacy outcomes were performed. Time from randomization to the first date of documented disease progression or death, assessed up to 5 years No
Secondary Time to Treatment Failure The distribution of all time to event data will be estimated using the method of Kaplan-Meier survival curves. The time from date of randomization to the date at which the patient is removed from the treatment, assessed up to 5 years No
Secondary Overall Survival Will be estimated using the method of Kaplan-Meier survival curves. A 1-sided stratified log rank test [accounting for all the stratification factors except FISH status and cooperative group] will be used to compare overall survival between the erlotinib and pemetrexed arms within the FISH(+) and FISH(-) subgroups, compare overall and progression free survival between the erlotinib and pemetrexed arms within the subgroups defined on the basis of the epidermal growth factor receptor (EGFR) expression by immunohistochemistry (IHC), and EGFR gene mutation status (MUT). Cox proportional hazards model will be used to assess potential differences. Time from randomization to time of death from any cause, assessed up to 5 years No
Secondary Confirmed Response Rate Defined as Complete Response (CR) or a Partial Response (PR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. The proportion of patients with confirmed CR and PR will be computed within each treatment arm and exact binomial confidence intervals for the true proportion computed. Chi-square test and Fisher's exact test will be used to compare the response rates between the treatment arms within the subgroups defined by FISH status, IHC, and MUT. Up to 5 years No
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