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COMPLETED

NCT00693992

PHASE3

Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.

Official title: Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511) as Maintenance Therapy in Non-progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2008-06-15

Completion Date

2015-05-28

Last Updated

2026-06-23

Healthy Volunteers

Conditions

Stage IIIB Lung Non-Small Cell Cancer AJCC v7 Stage IV Non-Small Cell Lung Cancer AJCC v7

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Placebo

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Sunitinib Malate

Given PO

Inclusion Criteria: * Histologic or cytologic documentation of primary non-small cell lung cancer * Stage IIIB or IV disease patients who are not candidates for combined modality therapy (chemoradiotherapy) * No evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis; patients with central nervous system (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 cavitary lesions * Patients must have received one chemotherapy regimen for stage IIIB or IV NSCLC; the regimen must include four cycles of platinum-based doublet chemotherapy with or without bevacizumab (bevacizumab may not be given beyond the fourth cycle of chemotherapy); patients must have achieved a complete response, partial response, or stable disease to first-line chemotherapy and have no evidence of disease progression; patients will be registered 3-5 weeks following day 1 of cycle 4 of prior therapy * No prior adjuvant chemotherapy for stage I-III resected NSCLC or combined modality therapy for stage III NSCLC * No other primary therapy (including experimental therapy) for NSCLC; palliative radiation therapy must have been completed at least one week before planned start of protocol therapy * 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 non-measurable 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 or 1 * Non-pregnant and non-nursing * No ongoing cardiac dysrhythmias, atrial fibrillation, or history of corrected QT (QTc) interval \>= 500 msec (within 2 years prior to registration); the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, 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 class III or IV NYHA heart failure within 12 months prior to registration 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 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 following inhibitors of cytochrome P450 3A4 (CYP3A4) are prohibited within 7 days before beginning 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 * Patients unable to take oral medication are not eligible * Granulocytes \>= 1,500/mcl * Platelet count \>= 100,000/mcl * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=\< 2.5 x ULN; patients with liver metastases may have AST and ALT =\< 5 x ULN; all other patients will have AST and ALT =\< 2.5 x ULN * Creatinine =\< 1.5 mg/dl

Locations (484)

Northeast Alabama Regional Medical Center

Anniston, Alabama, United States

Providence Hospital

Mobile, Alabama, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Veteran's Administration Medical Center

Little Rock, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

PCR Oncology

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

Feather River Cancer Center

Chico, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Kaiser Permanente-Fontana

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

Long Beach Memorial Medical Center-Todd Cancer Institute

Long Beach, 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

Memorial Medical Center

Modesto, California, United States

El Camino Hospital

Mountain View, California, United States

Palo Alto Medical Foundation-Camino Division

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

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Kaiser Permanente - Panorama City

Panorama City, 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

Kaiser Permanente-San Diego Mission

San Diego, California, United States

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Naval Medical Center -San Diego

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

Saint Helena Hospital

St. Helena, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Northbay Cancer Center

Vacaville, California, United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Middlesex Hospital

Middletown, Connecticut, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Beebe Medical Center

Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Nanticoke Memorial Hospital

Seaford, Delaware, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Howard University Hospital

Washington D.C., District of Columbia, United States

Boca Raton Comprehensive Cancer Center

Boca Raton, Florida, United States

Florida Hospital Memorial Medical Center

Daytona Beach, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

John B Amos Cancer Center

Columbus, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Saint Anthony's Health

Alton, Illinois, United States

Rush - Copley Medical Center

Aurora, Illinois, United States

Mount Sinai Hospital Medical Center