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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Extensive Stage Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer

Intervention: sunitinib malate (Drug); cisplatin (Drug); carboplatin (Drug); etoposide (Drug); placebo (Other); laboratory biomarker analysis (Other)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Neal Ready, Principal Investigator, Affiliation: Cancer and Leukemia Group B

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)

Progression-free Survival (Phase II)

Secondary outcome:

Overall Survival

Number of Participants With Overall Tumor Response

Detailed description: PRIMARY OBJECTIVES: I. To determine the phase II dose for sunitinib (sunitinib malate) combined with cisplatin and etoposide. (Phase IB) II. To compare the progression-free survival of patients with extensive stage small cell lung cancer treated with cisplatin or carboplatin and etoposide followed by maintenance sunitinib to patients receiving the same chemotherapy followed by placebo. (Phase II) SECONDARY OBJECTIVES: I. To assess the single agent response rate for sunitinib given as monotherapy after chemotherapy. (Phase II) II. To assess the overall survival of patients treated with cisplatin or carboplatin and etoposide followed by sunitinib. (Phase II) III. To evaluate the toxicity and tolerability of maintenance sunitinib after cisplatin or carboplatin and etoposide. (Phase II) IV. To determine the association between vascular endothelial growth factor (VEGF) plasma levels and tumor response. (Phase II) OUTLINE: This is a phase I, dose-escalation study of sunitinib malate followed by a randomized phase II study. PHASE I (close to accrual 5/17/08): COMBINATION THERAPY: Patients receive cisplatin or carboplatin intravenously (IV) on day 1, etoposide IV on days 1-3, and sunitinib malate orally (PO) once daily (QD) on days 1-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive sunitinib malate PO alone QD. Treatment continues in the absence of disease progression or unacceptable toxicity. PHASE II: COMBINATION THERAPY: Patients receive cisplatin or carboplatin and etoposide as in Phase I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 3-8 weeks after completion of combination chemotherapy or >= 4 courses of combination therapy, patients with a responding or stable disease are randomized to 1 of 2 treatment arms. All patients must be euthyroid before starting on maintenance therapy. ARM I: Patients receive sunitinib malate PO QD. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm I. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 2 years.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

East Bay Radiation Oncology Center, Castro Valley, California 94546, United States

Valley Medical Oncology Consultants-Castro Valley, Castro Valley, California 94546, United States

Valley Medical Oncology Consultants-Fremont, Fremont, California 94538, United States

Contra Costa Regional Medical Center, Martinez, California 94553-3156, United States

El Camino Hospital, Mountain View, California 94040, United States

Alta Bates Summit Medical Center - Summit Campus, Oakland, California 94609, United States

Bay Area Breast Surgeons Inc, Oakland, California 94609, United States

Bay Area Tumor Institute, Oakland, California 94609, United States

Highland General Hospital, Oakland, California 94602, United States

Larry G Strieff MD Medical Corporation, Oakland, California 94609, United States

Tom K Lee Inc, Oakland, California 94609, United States

Palchak David MD, Pismo Beach, California 93449, United States

Doctors Medical Center- JC Robinson Regional Cancer Center, San Pablo, California 94806, United States

Beebe Medical Center, Lewes, Delaware 19958, United States

Christiana Care Health System-Christiana Hospital, Newark, Delaware 19718, United States

Lombardi Comprehensive Cancer Center at Georgetown University, Washington, District of Columbia 20057, United States

Holy Cross Hospital, Fort Lauderdale, Florida 33308, United States

Gainesville Hematology Oncology Associates, Gainesville, Florida 32605, United States

Jupiter Medical Center, Jupiter, Florida 33458, United States

Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

Memorial University Medical Center, Savannah, Georgia 31404, United States

Illinois CancerCare-Bloomington, Bloomington, Illinois 61701, United States

Saint Joseph Medical Center, Bloomington, Illinois 61701, United States

Graham Hospital Association, Canton, Illinois 61520, United States

Illinois CancerCare-Canton, Canton, Illinois 61520, United States

Illinois CancerCare-Carthage, Carthage, Illinois 62321, United States

Memorial Hospital, Carthage, Illinois 62321, United States

University of Chicago, Chicago, Illinois 60637, United States

Eureka Hospital, Eureka, Illinois 61530, United States

Illinois CancerCare-Eureka, Eureka, Illinois 61530, United States

Galesburg Cottage Hospital, Galesburg, Illinois 61401, United States

Illinois CancerCare Galesburg, Galesburg, Illinois 61401, United States

Illinois CancerCare-Havana, Havana, Illinois 62644, United States

Mason District Hospital, Havana, Illinois 62644, United States

Hopedale Medical Complex - Hospital, Hopedale, Illinois 61747, United States

Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois 61443, United States

Kewanee Hospital, Kewanee, Illinois 61443, United States

Adventist La Grange Memorial Hospital, La Grange, Illinois 60525, United States

Illinois CancerCare-Macomb, Macomb, Illinois 61455, United States

Mcdonough District Hospital, Macomb, Illinois 61455, United States

Holy Family Medical Center, Monmouth, Illinois 61462, United States

Illinois CancerCare-Monmouth, Monmouth, Illinois 61462, United States

Bromenn Regional Medical Center, Normal, Illinois 61761, United States

Community Cancer Center Foundation, Normal, Illinois 61761, United States

Illinois CancerCare-Community Cancer Center, Normal, Illinois 61761, United States

Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois 61350, United States

Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois 61350, United States

Illinois CancerCare-Pekin, Pekin, Illinois 61554, United States

Pekin Cancer Treatment Center, Pekin, Illinois 61554, United States

Pekin Hospital, Pekin, Illinois 61554, United States

Illinois CancerCare-Peoria, Peoria, Illinois 61615, United States

Illinois Oncology Research Association CCOP, Peoria, Illinois 61615, United States

Methodist Medical Center of Illinois, Peoria, Illinois 61603, United States

OSF Saint Francis Medical Center, Peoria, Illinois 61637, United States

Proctor Hospital, Peoria, Illinois 61614, United States

Illinois CancerCare-Peru, Peru, Illinois 61354, United States

Illinois Valley Hospital, Peru, Illinois 61354, United States

Illinois CancerCare-Princeton, Princeton, Illinois 61356, United States

Perry Memorial Hospital, Princeton, Illinois 61356, United States

Saint Anthony Medical Center, Rockford, Illinois 61108, United States

Illinois CancerCare-Spring Valley, Spring Valley, Illinois 61362, United States

Saint Margaret's Hospital, Spring Valley, Illinois 61362, United States

Elkhart Clinic, Elkhart, Indiana 46514-2098, United States

Elkhart General Hospital, Elkhart, Indiana 46515, United States

Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana 46514, United States

Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana 46845, 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 46545-1470, United States

Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana 46545-1470, 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

South Bend Clinic, South Bend, Indiana 46617, United States

Michiana Hematology Oncology-PC Westville, Westville, Indiana 46391, United States

Eastern Maine Medical Center, Bangor, Maine 04401, United States

University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland 21201, United States

Union Hospital of Cecil County, Elkton MD, Maryland 21921, United States

Peninsula Regional Medical Center, Salisbury, Maryland 21801, United States

Addison Gilbert Hospital, Gloucester, Massachusetts 01930, United States

Michiana Hematology Oncology PC-Niles, Niles, Michigan 49120, United States

Marie Yeager Cancer Center, Saint Joseph, Michigan 49085, United States

Lakeland Hospital, St. Joseph, Michigan 49085, United States

Minneapolis Veterans Medical Center, Minneapolis, Minnesota 55417, United States

University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota 55455, United States

University of Missouri - Ellis Fischel, Columbia, Missouri 65212, United States

Washington University School of Medicine, Saint Louis, Missouri 63110, United States

Nebraska Cancer Research Center, Lincoln, Nebraska 68510, United States

Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska 68124, United States

Alegent Health Immanuel Medical Center, Omaha, Nebraska 68122, United States

Creighton University Medical Center, Omaha, Nebraska 68131, United States

Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States

Nebraska Methodist Hospital, Omaha, Nebraska 68114, United States

New Hampshire Oncology-Hematology PA, Concord, New Hampshire 03301, United States

New Hampshire Oncology Hematology Associates, Hooksett, New Hampshire 03106, 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 PC-East Syracuse, East Syracuse, New York 13057, United States

Glens Falls Hospital, Glens Falls, New York 12801, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States

State University of New York Upstate Medical University, Syracuse, New York 13210, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Wayne Memorial Hospital, Goldsboro, North Carolina 27534, United States

Margaret R Pardee Memorial Hospital, Hendersonville, North Carolina 28791, United States

FirstHealth of the Carolinas-Moore Regional Hosiptal, Pinehurst, North Carolina 28374, United States

Iredell Memorial Hospital, Statesville, North Carolina 28677, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio 43210, United States

Ohio State University Medical Center, Columbus, Ohio 43210, United States

Miriam Hospital, Providence, Rhode Island 02906, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Beaufort Memorial Hospital, Beaufort, South Carolina 29902, United States

McLeod Regional Medical Center, Florence, South Carolina 29506, United States

Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont 05602, United States

University of Vermont, Burlington, Vermont 05401, United States

Danville Regional Medical Center, Danville, Virginia 24541, United States

Virginia Commonwealth University, Richmond, Virginia 23298, United States

Additional Information

Starting date: March 2007
Last updated: April 10, 2015

Page last updated: August 23, 2015

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