Pemetrexed and/or Sunitinib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
NCT ID: NCT00698815
Last Updated: 2022-02-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2008-04-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pemetrexed Disodium With or Without Sorafenib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT00454194
Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy
NCT00693992
First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin
NCT00982111
Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-small Cell Lung Cancer
NCT00738881
Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
NCT00447057
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To estimate the 18 week progression-free survival rate of pemetrexed (pemetrexed disodium) alone (Arm I), sunitinib (sunitinib malate) alone (Arm II) and pemetrexed plus sunitinib (Arm III) in the second-line setting of advanced non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. To compare the progression-free survival of the three arms. II. To estimate the response rate, duration of response, rate of stable disease, overall survival and to characterize the toxicity profiles of the three arms.
III. To estimate the response rate, duration of response, rate of stable disease, overall survival and toxicity of sunitinib in those patients on Arm I that receive this regimen in the third line setting.
IV. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer.
V. To test change in tumor size at 6 weeks (after 2 cycles of therapy, typically the first evaluation point in this type of study) as an early predictor of therapeutic activity in second-line treatment of non-small cell lung cancer.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: 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. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
ARM II: Patients receive sunitinib malate orally (PO) once daily (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: Patients receive pemetrexed disodium IV over 10 minutes on day 1 and sunitinib malate 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.
After completion of study treatment, patients are followed up every 6 weeks until disease progression and then every 6 months for 2 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I (pemetrexed)
Patients 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.
Laboratory Biomarker Analysis
Correlative studies
Pemetrexed Disodium
Given IV
Arm II (sunitinib)
Patients 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.
Laboratory Biomarker Analysis
Correlative studies
Sunitinib Malate
Given PO
Arm III (pemetrexed and sunitinib)
Patients 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.
Laboratory Biomarker Analysis
Correlative studies
Pemetrexed Disodium
Given IV
Sunitinib Malate
Given PO
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laboratory Biomarker Analysis
Correlative studies
Pemetrexed Disodium
Given IV
Sunitinib Malate
Given PO
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Lesions that are considered non-measurable include the following:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Pregnant or nursing mothers are not eligible for this study; patients in their child bearing years must have a baseline negative pregnancy test (in the case of females); males and females must practice appropriate contraceptive measures during the period of protocol therapy and for 6 months after completion of protocol therapy; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier method (diaphragm plus condom)
* No ongoing cardiac dysrhythmias, atrial fibrillation, or history of corrected QT interval (QTc interval) \> 500 msec (within 2 years prior to registration); the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, flecainide) is not recommended while on protocol therapy
* Patients with class I New York Heart Association (NYHA) heart failure are eligible; patients with a history of class II NYHA heart failure are eligible, provided they meet at least one of the following criteria:
* Patients with a history of class II heart failure who are asymptomatic on treatment
* Patients with prior anthracycline exposure
* Patients who have received central thoracic radiation that included the heart in the radiotherapy port
* Patients with a history of symptomatic congestive heart failure within 12 months prior to entry are not eligible
* No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident or transient ischemic attack within the last year
* Patients with hypertension that cannot be controlled by medications (\> 150/100 mmHg despite optimal medical therapy) are not eligible
* Patients who require use of therapeutic anticoagulation for thromboembolic disease are not eligible; Note: low doses of Coumadin (up to 2 mg daily) are permitted for prophylaxis of thrombosis
* No history of venous thrombosis, pulmonary embolism, or hypercoagulopathy syndrome
* No history of pulmonary hemorrhage, bleeding diathesis, or evidence of hemoptysis; patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 mL of blood per episode and less than 10 mL of blood per 24-hour period in the best estimate of the investigator
* Patients with a history of hypothyroidism or hyperthyroidism are eligible, provided they are currently euthyroid
* None of the following within 28 days of beginning treatment: abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious or non-healing wound, ulcer, or bone fracture
* The use of the following specific inhibitors and inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not permitted; the following inhibitors of CYP3A4 are prohibited within 7 days before and during treatment with sunitinib: azole antifungals (ketoconazole, itraconazole), diltiazem, clarithromycin, erythromycin, verapamil, delavirdine, and human immunodeficiency virus (HIV) protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir); the following inducers of CYP3A4 are prohibited within 12 days before beginning and during treatment with sunitinib: rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John's Wort, efavirenz, tipranavir
* Other inhibitors and inducers of CYP3A4 may be used if necessary, but their use is discouraged
* No symptomatic or untreated central nervous system (CNS) metastases; patients with CNS metastases must be asymptomatic, must have received definitive therapy (\>= 6 weeks since resection or \>= 2 weeks since radiotherapy) for brain metastases, and be off steroids or on a stable dose for 2 weeks prior to registration
* No chronic daily treatment with aspirin (\> 325 mg/day) or non-steroidal antiinflammatory agents known to inhibit platelet function; treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is not allowed
* No pleural effusions or ascites that are detectable on physical exam
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rebecca Heist
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kaiser Permanente-Anaheim
Anaheim, California, United States
Arroyo Grande Community
Arroyo Grande, California, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States
Kaiser Permanente-Bellflower
Bellflower, California, United States
East Bay Radiation Oncology Center
Castro Valley, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Kaiser Permanente Hospital
Fontana, California, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States
Kaiser Permanente - Harbor City
Harbor City, California, United States
Kaiser Permanente-Irvine
Irvine, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Kaiser Permanente-Cadillac
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
El Camino Hospital
Mountain View, California, United States
Highland General Hospital
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Hematology and Oncology Associates-Oakland
Oakland, California, United States
Tom K Lee Inc
Oakland, California, United States
Kaiser Permanente - Panorama City
Panorama City, California, United States
PCR Oncology
Pismo Beach, California, United States
Valley Care Health System - Pleasanton
Pleasanton, California, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
Kaiser Permanente-Riverside
Riverside, California, United States
University of California San Diego
San Diego, California, United States
Kaiser Permanente-San Diego Mission
San Diego, California, United States
Kaiser Permanente-San Diego Zion
San Diego, California, United States
Kaiser Permanente-San Marcos
San Marcos, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States
Kaiser Permanente
Woodland Hills, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Middlesex Hospital
Middletown, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States
AMITA Health Adventist Medical Center
La Grange, Illinois, United States
Elkhart Clinic
Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Iowa City VA Healthcare System
Iowa City, Iowa, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Lakeland Community Hospital
Niles, Michigan, United States
Lakeland Hospital
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, United States
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Center for Cancer Care and Research
St Louis, Missouri, United States
Comprehensive Cancer Care PC
St Louis, Missouri, United States
CHI Health Saint Francis
Grand Island, Nebraska, United States
Nebraska Cancer Research Center
Lincoln, Nebraska, United States
Great Plains Regional Medical Center
North Platte, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Exeter Hospital
Exeter, New Hampshire, United States
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Northwell Health/Center for Advanced Medicine
New Hyde Park, New York, 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
Randolph Hospital
Asheboro, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Kinston Medical Specialists PA
Kinston, North Carolina, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Marion L Shepard Cancer Center at Vidant Beaufort Hospital
Washington, North Carolina, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Self Regional Healthcare
Greenwood, South Carolina, United States
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States
University of Vermont College of Medicine
Burlington, Vermont, United States
Danville Regional Medical Center
Danville, Virginia, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, United States
Saint Mary's Medical Center
Huntington, West Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2009-00471
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000589102
Identifier Type: -
Identifier Source: secondary_id
CALGB 30704
Identifier Type: OTHER
Identifier Source: secondary_id
CALGB-30704
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00471
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.