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

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Pemetrexed Disodium (ALIMTA®) Plus Bevacizumab in Patients With Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268489
• Other study ID #: NCCTG-N0426
• Secondary ID: NCI-2012-02681SW
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2005
• Last updated: July 1, 2016
• Start date: May 2006
• Est. completion date: April 2010

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• 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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium together with bevacizumab may be an effective treatment for non-small cell lung cancer.

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

Description:

OBJECTIVES:

Primary

• Assess the 3 month progression-free survival rate of the combination of pemetrexed disodium with bevacizumab in a patient population with stage IIIB (due to pleural effusion) or IV non-small cell lung cancer.

Secondary

• Determine the tumor response rate in these patients.

• Determine the effect of pemetrexed disodium in combination with bevacizumab on overall survival and duration of response in these patients.

• Determine the toxicity profile of this drug regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes 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 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2010
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically diagnosed stage IIIB or IV non-small cell lung cancer

• Stage IIIB patients must have pleural effusion

• No symptomatic serosal effusion (grade 2 dyspnea) that is not amenable to drainage

• Mixed histology allowed if all components consistent with non-small cell lung cancer

• Tumors with squamous cell histology feature are allowed

• Must have measurable disease with at least one lesion with a longest diameter accurately measured as = 2.0 cm with conventional techniques or as = 1.0 cm with spiral CT

• Large ( > 4 cm) centrally located lesions or large lesions in close proximity to major blood vessels should receive palliative radiation

• The irradiated lesion should not be a target lesion

• Previously treated with one chemotherapy regimen in the neoadjuvant, adjuvant, or advanced disease setting

• No symptomatic, untreated, or uncontrolled CNS metastases

• CNS metastases treated with prior whole brain radiotherapy allowed

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy = 12 weeks

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

• Platelet count = 100,000/ mm^3

• Hemoglobin = 9 g/dL

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

• AST and ALT = 3 times ULN (5 times ULN if liver has tumor involvement)

• Creatinine clearance = 45 mL/min

• Urine protein:creatinine ratio < 1.0

• Pregnant or nursing women are ineligible

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• No seizure disorder

• No clinically significant infection

• No other second primary malignancy within the past 5 years except carcinoma in situ of the cervix, non-melanomatous skin cancer, or low-grade (Gleason score = 6) localized prostate cancer

• No hypertension or labile hypertension

• No history of poor compliance with antihypertensive medications

• No angina pectoris

• No congestive heart failure within the past 3 months unless ejection fraction > 40%

• No myocardial infarction within the past 6 months

• No cardiac arrhythmia

• No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung

• No active or recent history of hemoptysis

• Hemoptysis resolved > 2 weeks ago with measures such as palliative radiation therapy (i.e., 3,000 cGy over 10 fractions), arteriographic embolization, or endobronchial interventions (e.g., photodynamic therapy or brachytherapy) is acceptable

• No diabetes

• No prior serious, non-healing wounds, ulcers, or bone fractures

• No history of stroke within the past 6 months

• No history of abdominal fistula or gastrointestinal perforation

• No intra-abdominal abscess within the past 6 months

• Not at greater than average risk of bleeding

• No significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

• No aspirin at doses = 1.3 grams per day within 10 days prior to or 10 days after pemetrexed disodium treatment

• No chemotherapy within the past 3 weeks (6 weeks for mitomycin C or nitrosoureas)

• No immunotherapy or biologic therapy within the past 2 weeks

• No full field radiation therapy within the past 4 weeks or limited field radiation therapy within the past 2 weeks

• The site of previous radiotherapy should have evidence of progressive disease if it is the only site of disease

• No prior post pelvic radiation

• No prior use of pemetrexed disodium

• No prior radiation to > 25% of the marrow cavity

• No major surgery (i.e., laparotomy) or open biopsy within the past 4 weeks

• No minor surgery within the past 2 weeks except insertion of a vascular access device

• No concurrent major surgery

• No other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any ancillary therapy considered investigational within the past 4 weeks

• No concurrent use of Hypericum perforatum (St. John's wort)

• No concurrent anticoagulant use

• Low-dose warfarin or heparin for deep venous thrombosis prophylaxis allowed

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

Biological:
• bevacizumab

Drug:
• pemetrexed disodium

Locations

Country	Name	City	State
United States	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois
United States	McFarland Clinic, PC	Ames	Iowa
United States	Providence Cancer Center	Anchorage	Alaska
United States	AnMed Health 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	Randolph Hospital	Asheboro	North Carolina
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Northside Hospital Cancer Center	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	WellStar Cobb Hospital	Austell	Georgia
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	MeritCare Clinic - Bemidji	Bemidji	Minnesota
United States	Billings Clinic Cancer Center	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Deaconess Billings Clinic - Downtown	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	Billings	Montana
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Cancer Care Center at Medcenter One Hospital	Bismarck	North Dakota
United States	Mid Dakota Clinic, PC	Bismarck	North Dakota
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	St. James Community Hospital	Butte	Montana
United States	Graham Hospital	Canton	Illinois
United States	Saint Francis Medical Center	Cape Girardeau	Missouri
United States	Memorial Hospital	Carthage	Illinois
United States	Eden Medical Center	Castro Valley	California
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Hollings Cancer Center at Medical University of South Carolina	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 Riverside Cancer Services	Columbus	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Danville Regional Medical Center	Danville	Virginia
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	CCOP - Dayton	Dayton	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	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	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia
United States	Grady Memorial Hospital	Delaware	Ohio
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa
United States	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Mercy Capitol Hospital	Des Moines	Iowa
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	CCOP - Duluth	Duluth	Minnesota
United States	Miller-Dwan Medical Center	Duluth	Minnesota
United States	St. Mary's - Duluth Clinic Cancer Center	Duluth	Minnesota
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan
United States	Eureka Community Hospital	Eureka	Illinois
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	MeritCare Medical Group	Fargo	North Dakota
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	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Galesburg Clinic	Galesburg	Illinois
United States	Galesburg Cottage Hospital	Galesburg	Illinois
United States	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Gape Girardeau	Missouri
United States	Adirondack Cancer Care - Glens Falls	Glens Falls	New York
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota
United States	Big Sky Oncology	Great Falls	Montana
United States	Sletten Regional Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology, Limited at St. Vincent Hospital	Green Bay	Wisconsin
United States	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North 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	Mason District Hospital	Havana	Illinois
United States	Saint Rose Hospital	Hayward	California
United States	St. Peter's Hospital	Helena	Montana
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Green Bay Oncology, Limited - Iron Mountain	Iron Mountain	Michigan
United States	Foote Hospital	Jackson	Michigan
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Joliet Oncology-Hematology Associates, Limited - West	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	CCOP - Kansas City	Kansas City	Missouri
United States	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Franciscan Skemp Healthcare	La Crosse	Wisconsin
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	Southwest Medical Center	Liberal	Kansas
United States	Meeker County Memorial Hospital	Lichfield	Minnesota
United States	Cancer Resource Center - Lincoln	Lincoln	Nebraska
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	McDonough District Hospital	Macomb	Illinois
United States	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota
United States	Minnesota Oncology Hematology, PA at Maplewood Cancer Center	Maplewood	Minnesota
United States	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin
United States	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Middletown Regional Hospital	Middletown	Ohio
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota
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	Chippewa County - Montevideo Hospital	Montevideo	Minnesota
United States	Ted B. Wahby Cancer Center at Mount Clemens General Hospital	Mount Clemens	Michigan
United States	Good Samaritan Regional Health Center	Mt. Vernon	Illinois
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Alta Bates Summit Medical Center - Summit Campus	Oakland	California
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Highland General Hospital at St. George's University School of Medicine	Oakland	California
United States	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois
United States	McCreery Cancer Center at Ottumwa Regional	Ottumwa	Iowa
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Valley Care Medical Center	Pleasanton	California
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Legacy Emanuel Hospital and Health Center & Children's Hospital	Portland	Oregon
United States	Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center	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	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Annie Penn Cancer Center	Reidsville	North Carolina
United States	Reid Hospital & Health Care Services, Incorporated	Richmond	Indiana
United States	Southern Regional Medical Center	Riverdale	Georgia
United States	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Seton Cancer Institute - Saginaw	Saginaw	Michigan
United States	Coborn Cancer Center	Saint Cloud	Minnesota
United States	Arch Medical Services, Incorporated at Center for Cancer Care Research	Saint Louis	Missouri
United States	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Salem Hospital Regional Cancer Care Services	Salem	Oregon
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas
United States	Doctors Medical Center - San Pablo Campus	San Pablo	California
United States	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	Guthrie Cancer Center at Guthrie Clinic Sayre	Sayre	Pennsylvania
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
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	Saint Francis Cancer Center	Shakopee	Minnesota
United States	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	Siouxland Regional Cancer Center	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Medical X-Ray Center, PC	Sioux Falls	South Dakota
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
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	St. Margaret's Hospital	Spring Valley	Illinois
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	St. Joseph's Hospital	St Paul	Minnesota
United States	CentraCare Clinic - River Campus	St. Cloud	Minnesota
United States	CCOP - St. Louis-Cape Girardeau	St. Louis	Missouri
United States	Missouri Baptist Cancer Center	St. Louis	Missouri
United States	Park Nicollet Health Services	St. Louis Park	Minnesota
United States	Regions Hospital Cancer Care Center	St. Paul	Minnesota
United States	United Hospital	St. Paul	Minnesota
United States	Iredell Memorial Hospital	Statesville	North Carolina
United States	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Pearlman Comprehensive Cancer Center at South Georgia Medical Center	Valdosta	Georgia
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	St. John Macomb Hospital	Warren	Michigan
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital	Westerville	Ohio
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota
United States	Woodwinds Health Campus	Woodbury	Minnesota
United States	United States Air Force Medical Center - Wright-Patterson	Wright-Patterson Afb	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
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Adjei AA, Mandrekar SJ, Dy GK, et al.: A phase II second-line study of pemetrexed (pem) in combination with bevacizumab (bev) in patients with advanced non-small cell lung cancer (NSCLC): An NCCTG and SWOG study. [Abstract] J Clin Oncol 26 (Suppl 15): A-8

Adjei AA, Mandrekar SJ, Dy GK, Molina JR, Adjei AA, Gandara DR, Ziegler KL, Stella PJ, Rowland KM Jr, Schild SE, Zinner RG. Phase II trial of pemetrexed plus bevacizumab for second-line therapy of patients with advanced non-small-cell lung cancer: NCCTG a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of progression-free patients at 3 months		at 3 months	No
Secondary	Response (complete and partial) as assessed by RECIST criteria		Up to 5 years	No
Secondary	Overall survival		Up to 5 years	No
Secondary	Progression-free survival		Up to 5 years	No
Secondary	Duration of response		Up to 5 years	No
Secondary	Time to treatment failure		Up to 5 years	No