S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Phase II Trial of Pemetrexed in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00265785
• Other study ID #: CDR0000456424
• Secondary ID: U10CA032102S0526
• Status: Terminated
• Phase: Phase 2
• First received: December 14, 2005
• Last updated: October 3, 2012
• Start date: July 2006
• Est. completion date: July 2011

Study information

• Verified date: October 2012
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with stage III or stage IV non-small cell lung cancer.

Description:

OBJECTIVES:

Primary

• Assess overall survival of patients with selected stage IIIB or IV bronchoalveolar carcinoma treated with pemetrexed disodium.

Secondary

• Evaluate the progression-free survival of patients treated with this drug.

• Evaluate the response rate (confirmed and unconfirmed, partial and complete) in the subset of patients with measurable disease treated with this drug using standard RECIST criteria and computer assisted image analysis.

• Evaluate frequency and severity of toxicities in patients treated with this drug.

• Perform molecular correlative studies on patient tissue to investigate potential predictors of efficacy. (This will not be completed as this study was closed due to poor accrual.)

OUTLINE: Patients are stratified according to prior treatment with gefitinib or erlotinib (yes vs no).

Patients receive pemetrexed disodium intravenous (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed bronchoalveolar carcinoma (BAC) or BAC variants such as adenocarcinoma with BAC features or BAC with invasive adenocarcinoma

• Cytology specimens, such as bronchial brushings, washings, or fine needle aspiration specimens alone are not acceptable for diagnosis

• Stage IV disease OR selected stage IIIB (T4 [secondary to malignant pleural effusion only], any N, M0) disease

• Incompletely resected or unresectable disease

• Pleural effusions, ascites, or laboratory parameters cannot be only evidence of disease

• Measurable disease or nonmeasurable disease documented by CT scan

• No known brain metastases

PATIENT CHARACTERISTICS:

• Bilirubin = 1.5 times upper limit of normal (ULN)

• SGOT and SGPT = 2.5 times ULN ( = 5 times ULN if due to liver metastases)

• Alkaline phosphatase = 2.5 times ULN ( = 5 times ULN if due to bone metastases)

• Creatinine clearance = 45 mL/min OR creatinine = 1.5 times ULN

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 75,000/mm³

• Zubrod 0-2

• No history of allergic reaction to compounds of similar chemical or biological composition as pemetrexed disodium

• Must provide smoking history

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Able to swallow pills

PRIOR CONCURRENT THERAPY:

• No more than 2 prior systemic therapies (including epidermal growth factor receptor inhibitor)

• At least 28 days since prior systemic therapy

• Patients treated with prior erlotinib or gefitinib must have shown progression since treatment

• No prior pemetrexed disodium

• At least 28 days since prior radiotherapy and recovered

• Must have measurable or nonmeasurable disease outside previously irradiated area or a new lesion within previously irradiated area

• At least 14 days since prior palliative radiotherapy and recovered

• At least 28 days since prior thoracic or major surgery and recovered

• No concurrent surgery

• No other concurrent therapy (hormonal, biologic or radiotherapy) for this disease

• No concurrent antiretroviral therapy

• Patients should discontinue non-steroidal anti-inflammatory drugs (NSAIDs) with longer half lives (etodolac, ketordac, sulindac, naproxen, naproxen sodium, oxaprozin, nabumetone, diflunisal, salsalate, celecoxib, rofecoxib, valdecoxib, meloxicam, piroxicam) at least 5 days before and for 2 days following pemetrexed treatment

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• pemetrexed
Pemetrexed 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay = 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.

Locations

Country	Name	City	State
United States	Kapiolani Medical Center at Pali Momi	Aiea	Hawaii
United States	Alaska Regional Hospital Cancer Center	Anchorage	Alaska
United States	AnMed Cancer Center	Anderson	South Carolina
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	Mary Rutan Hospital	Bellefontaine	Ohio
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	St. James Healthcare Cancer Care	Butte	Montana
United States	Roper St. Francis Cancer Center at Roper Hospital	Charleston	South Carolina
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Medical Center Cancer Care	Columbus	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Danville Regional Medical Center	Danville	Virginia
United States	CCOP - Dayton	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Denver Health Medical Center	Denver	Colorado
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Middletown Regional Hospital	Franklin	Ohio
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	CCOP - Greenville	Greenville	South Carolina
United States	Legacy Mount Hood Medical Center	Gresham	Oregon
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Northern Montana Hospital	Havre	Montana
United States	St. Peter's Hospital	Helena	Montana
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Hawaii Medical Center - East	Honolulu	Hawaii
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii
United States	OnCare Hawaii, Incorporated - Lusitana	Honolulu	Hawaii
United States	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii
United States	Foote Memorial Hospital	Jackson	Michigan
United States	NEA Medical Center - Stadium Boulevard	Jonesboro	Arkansas
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology at KRMC	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Columbia Basin Hematology	Kennewick	Washington
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	St. Mary Mercy Hospital	Livonia	Michigan
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Community Medical Center	Missoula	Montana
United States	Guardian Oncology and Center for Wellness	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan
United States	Adventist Medical Center	Portland	Oregon
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	Oregon
United States	Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Portland	Oregon
United States	Oregon Health and Science University Cancer Institute	Portland	Oregon
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Reid Hospital & Health Care Services	Richmond	Indiana
United States	Interlakes Oncology/Hematology PC	Rochester	New York
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	University of California Davis Cancer Center	Sacramento	California
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Minor and James Medical, PLLC	Seattle	Washington
United States	Polyclinic First Hill	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming
United States	Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	Michigan
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Mercy Medical Center	Springfield	Ohio
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Cotton-O'Neil Cancer Center	Topeka	Kansas
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
United States	Maui Memorial Medical Center	Wailuku	Hawaii
United States	St. John Macomb Hospital	Warren	Michigan
United States	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio
United States	Clinton Memorial Hospital	Wilmington	Ohio
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.	0 - 3 years	No
Secondary	Progression-free Survival	Progression is defined as any one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as globabl deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Progression-free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.	0 - 3 years	No
Secondary	Response (Confirmed and Unconfirmed, Complete and Partial)	Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.	Assessed at weeks 7 and 13 while on treatment. After off treatment prior to disease progression, disease assessment takes place every 3 months for a maximum of 3 years.	No
Secondary	Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.	Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued after every cycle of treatment (every 3 weeks) for the duration of protocol treatment.	Yes