Pemetrexed and/or Sunitinib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
A Randomized Phase II Study to Assess the Efficacy of Pemetrexed or Sunitinib (NSC # 736511) or Pemetrexed Plus Sunitinib in the Second-Line Treatment of Advanced Non-small Cell Lung Cancer
6 other identifiers
interventional
130
1 country
129
Brief Summary
This randomized phase II trial studies pemetrexed disodium and sunitinib malate to compare how well they work when given alone or together as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer. 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. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether pemetrexed disodium and sunitinib malate are more effective when given alone or together in treating non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
129 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2008
CompletedFirst Submitted
Initial submission to the registry
June 14, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedResults Posted
Study results publicly available
March 19, 2015
CompletedFebruary 8, 2022
January 1, 2022
3.6 years
June 14, 2008
February 17, 2015
January 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
18 Week Progression-free Survival (PFS) Rate
The 18 week progression-free survival rate was defined as the proportion of patients that were alive and progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated.
At 18 weeks
Secondary Outcomes (3)
PFS
Time from randomization to disease progression and death of any cause, whichever comes first (up to 3 years)
Overall Response Rate
Duration of treatment (up to 3 years)
Overall Survival (OS)
Time from randomization to death (up to 3 years)
Study Arms (3)
Arm I (pemetrexed)
EXPERIMENTALPatients receive pemetrexed disodium 500 mg/m\^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
Arm II (sunitinib)
EXPERIMENTALPatients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
Arm III (pemetrexed and sunitinib)
EXPERIMENTALPatients receive pemetrexed disodium 500 mg/m\^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
Interventions
Correlative studies
Given IV
Given PO
Eligibility Criteria
You may qualify if:
- Histologic documentation: histologic or cytologic documentation of NSCLC
- Stage: IIIB/IV with evidence of disease progression following first-line therapy
- Tumor site: lung (non-small cell)
- No cavitary lesions
- Only one prior chemotherapy regimen in the first-line stage IIIB/IV setting is allowed; this could have been either a platinum- or non-platinum-based regimen
- First-line therapy must be completed \>= 28 days before registration
- Prior adjuvant therapy is allowed provided the patient had one previous regimen in the advanced stage IIIB/IV setting
- At least 28 days from prior major surgery and at least 14 days from any prior radiotherapy before registration
- No prior inhibitors of VEGF receptor (VEGFR) (e.g., SU5416, SU6668, AZ6474, SU11248, PTK787, AZD2171, AEE-788, sorafenib); prior treatment with epidermal growth factor receptor (EGFR) inhibitors and bevacizumab is allowed, provided at least 4 weeks has elapsed
- No prior pemetrexed
- Patients must have measurable or non-measurable disease
- Measurable disease
- Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 2 cm with conventional techniques or as \>= 1 cm with spiral computed tomography (CT) scan
- Non-measurable disease
- All other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly nonmeasurable lesions
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (129)
Kaiser Permanente-Anaheim
Anaheim, California, 92807, United States
Arroyo Grande Community
Arroyo Grande, California, 93420, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
East Bay Radiation Oncology Center
Castro Valley, California, 94546, United States
Eden Hospital Medical Center
Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546, United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
Kaiser Permanente Hospital
Fontana, California, 92335, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538, United States
Kaiser Permanente - Harbor City
Harbor City, California, 90710, United States
Kaiser Permanente-Irvine
Irvine, California, 92618, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Kaiser Permanente-Cadillac
Los Angeles, California, 90034, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
El Camino Hospital
Mountain View, California, 94040, United States
Highland General Hospital
Oakland, California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Hematology and Oncology Associates-Oakland
Oakland, California, 94609, United States
Tom K Lee Inc
Oakland, California, 94609, United States
Kaiser Permanente - Panorama City
Panorama City, California, 91402, United States
PCR Oncology
Pismo Beach, California, 93449, United States
Valley Care Health System - Pleasanton
Pleasanton, California, 94588, United States
Valley Medical Oncology Consultants
Pleasanton, California, 94588, United States
Kaiser Permanente-Riverside
Riverside, California, 92505, United States
University of California San Diego
San Diego, California, 92103, United States
Kaiser Permanente-San Diego Mission
San Diego, California, 92108, United States
Kaiser Permanente-San Diego Zion
San Diego, California, 92120, United States
Kaiser Permanente-San Marcos
San Marcos, California, 92069, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806, United States
Kaiser Permanente
Woodland Hills, California, 91367, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Middlesex Hospital
Middletown, Connecticut, 06457, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435, United States
AMITA Health Adventist Medical Center
La Grange, Illinois, 60525, United States
Elkhart Clinic
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, 46601, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Iowa City VA Healthcare System
Iowa City, Iowa, 52246, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, 01757, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
Lakeland Community Hospital
Niles, Michigan, 49120, United States
Lakeland Hospital
Saint Joseph, Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
Comprehensive Cancer Care PC
St Louis, Missouri, 63141, United States
CHI Health Saint Francis
Grand Island, Nebraska, 68803, United States
Nebraska Cancer Research Center
Lincoln, Nebraska, 68510, United States
Great Plains Regional Medical Center
North Platte, Nebraska, 69103, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106, United States
Exeter Hospital
Exeter, New Hampshire, 03833, United States
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, 03246, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Northwell Health/Center for Advanced Medicine
New Hyde Park, New York, 11040, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Syracuse Veterans Administration Medical Center
Syracuse, New York, 13210, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Kinston Medical Specialists PA
Kinston, North Carolina, 28501, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Marion L Shepard Cancer Center at Vidant Beaufort Hospital
Washington, North Carolina, 27889, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, 28401, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, 29640, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, 29650, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, 29672, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, 29307, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont College of Medicine
Burlington, Vermont, 05405, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, 24115, United States
Saint Mary's Medical Center
Huntington, West Virginia, 25702, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rebecca S. Heist, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Heist
Alliance for Clinical Trials in Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2008
First Posted
June 17, 2008
Study Start
April 15, 2008
Primary Completion
December 1, 2011
Last Updated
February 8, 2022
Results First Posted
March 19, 2015
Record last verified: 2022-01