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COMPLETED

NCT00453154

PHASE1/PHASE2

Cisplatin or Carboplatin, and Etoposide With or Without Sunitinib Malate in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This partially randomized phase I/II trial studies the side effects and best dose of sunitinib malate and to see how well it works when given together with cisplatin or carboplatin and etoposide in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and etoposide, 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 cisplatin or carboplatin and etoposide are more effective when given with or without sunitinib malate in treating small cell lung cancer.

Official title: Combination Chemotherapy With or Without Maintenance Sunitinib Malate (NSC 736511) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2007-03-15

Completion Date

2015-08-20

Last Updated

2026-06-16

Healthy Volunteers

Conditions

Extensive Stage Lung Small Cell Carcinoma Recurrent Lung Small Cell Carcinoma

Interventions

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Etoposide

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Placebo Administration

Given PO

DRUG

Sunitinib Malate

Given PO

Inclusion Criteria: * All patients must have histologically or cytologically documented small cell lung cancer * Eligible disease stages: the extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive stage patients are defined as those patients with extrathoracic metastatic, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy * All patients must have measurable disease: * Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan * Lesions that are considered non-measurable, which would make the patient not eligible, 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 * No prior chemotherapy for small cell lung cancer (SCLC) * Radiation therapy must have been completed at least one week before initiation of protocol therapy * Common Toxicity Criteria (CTC) performance status: * Phase IB: 0-1 * Phase II: 0-2 * No "currently active" second malignancy other than non-melanoma skin cancers * No history of brain metastases, spinal cord compression, or carcinomatous meningitis * No ongoing cardiac dysrhythmias, atrial fibrillation, or QTc interval \>= 500 msec; the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, pedridel, haloperidol, risperidone, indapamide, flecainide) is not recommended while on protocol therapy * Patients with class I New York Heart Association (NYHA) are eligible; patients with a history of class II NYHA are eligible, provided they meet 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 * Additionally, no myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident including transient ischemic attack, or pulmonary embolism 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 doses of coumarin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis; Note: Low molecular weight heparin is permitted provided the patient's prothrombin time (PT) international normalized ratio (INR) is =\< 1.5 * No evidence of hemoptysis within 4 weeks prior to starting study treatment; 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 * None of the following within 28 days of 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 there use is discouraged * Non-pregnant and non-nursing * Granulocytes \>= 1,500/ul * Platelets \>= 100,000/ul * Creatinine clearance \>= 70 ml/min * Total bilirubin =\< 1.5 mg/dl * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) (patients w/ liver metastases may have AST/ALT =\< 5 x ULN) * Partial thromboplastin time (PTT) =\< 1.5 x ULN

Locations (125)

Arroyo Grande Community

Arroyo Grande, California, United States

PCR Oncology

Arroyo Grande, California, United States

East Bay Radiation Oncology 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

Valley Medical Oncology Consultants-Fremont

Fremont, 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

UCSF Medical Center-Mount Zion

San Francisco, California, United States

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, 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

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Florida Cancer Specialists-Gainesville Cancer Center

Gainesville, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Saint Joseph Medical Center

Bloomington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Graham Hospital Association

Canton, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Memorial Hospital

Carthage, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Eureka Hospital

Eureka, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Illinois CancerCare-Havana

Havana, Illinois, United States

Mason District Hospital

Havana, Illinois, United States

Hopedale Medical Complex - Hospital

Hopedale, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Kewanee Hospital

Kewanee, Illinois, United States

AMITA Health Adventist Medical Center

La Grange, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Mcdonough District Hospital

Macomb, Illinois, United States

Holy Family Medical Center

Monmouth, Illinois, United States

Illinois CancerCare-Monmouth

Monmouth, Illinois, United States

Bromenn Regional Medical Center

Normal, Illinois, United States

Community Cancer Center Foundation

Normal, Illinois, United States

Illinois CancerCare-Community Cancer Center

Normal, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, United States

Pekin Hospital

Pekin, Illinois, United States

Proctor Hospital

Peoria, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Illinois Valley Hospital

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Perry Memorial Hospital

Princeton, Illinois, United States

OSF Saint Anthony Medical Center

Rockford, Illinois, United States

Illinois CancerCare-Spring Valley

Spring Valley, Illinois, United States

Saint Margaret's Hospital

Spring Valley, 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

Fort Wayne Medical Oncology and Hematology Inc-Parkview

Fort Wayne, 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

South Bend Clinic

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/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Eastern Maine Medical Center

Bangor, Maine, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Union Hospital of Cecil County

Elkton, Maryland, United States

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Addison Gilbert Hospital

Gloucester, Massachusetts, United States

Lakeland Hospital Niles

Niles, Michigan, United States

Lakeland Medical Center Saint Joseph

Saint Joseph, Michigan, United States

Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

University of Missouri - Ellis Fischel

Columbia, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

CHI Health Saint Francis

Grand Island, Nebraska, United States

Nebraska Cancer Research Center

Lincoln, Nebraska, United States

Great Plains Health Callahan Cancer Center

North Platte, Nebraska, United States

Missouri Valley Cancer Consortium