Lung Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

156

Study ID:

NCT00453154

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 100 Locations for this study

See Locations Near You

Arroyo Grande Community
Arroyo Grande California, 93420, United States
PCR Oncology
Arroyo Grande California, 93420, United States
East Bay Radiation Oncology 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
Valley Medical Oncology Consultants-Fremont
Fremont California, 94538, United States
Contra Costa Regional Medical Center
Martinez California, 94553, 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
UCSF Medical Center-Mount Zion
San Francisco California, 94115, 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
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
Florida Cancer Specialists-Gainesville Cancer Center
Gainesville Florida, 32605, United States
Jupiter Medical Center
Jupiter Florida, 33458, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Memorial Health University Medical Center
Savannah Georgia, 31404, United States
Saint Joseph Medical Center
Bloomington Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington Illinois, 61704, 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 Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Heartland Cancer Research NCORP
Decatur Illinois, 62526, 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
AMITA Health Adventist Medical Center
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
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin Illinois, 61554, United States
Pekin Hospital
Pekin Illinois, 61554, United States
Proctor Hospital
Peoria Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria Illinois, 61637, 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
OSF 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, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart Indiana, 46514, United States
Elkhart General Hospital
Elkhart Indiana, 46515, 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, 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
South Bend Clinic
South Bend Indiana, 46617, 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/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, 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 Maryland, 21921, United States
Peninsula Regional Medical Center
Salisbury Maryland, 21801, United States
Addison Gilbert Hospital
Gloucester Massachusetts, 01930, United States
Lakeland Hospital Niles
Niles Michigan, 49120, United States
Lakeland Medical Center Saint Joseph
Saint Joseph Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph Michigan, 49085, United States
Minneapolis VA Medical Center
Minneapolis Minnesota, 55417, United States
University of Minnesota/Masonic Cancer Center
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
CHI Health Saint Francis
Grand Island Nebraska, 68803, United States
Nebraska Cancer Research Center
Lincoln Nebraska, 68510, United States
Great Plains Health Callahan Cancer Center
North Platte Nebraska, 69101, United States
Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, 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
New Hampshire Oncology Hematology PA-Concord
Concord New Hampshire, 03301, United States
New Hampshire Oncology Hematology PA-Hooksett
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
Roswell Park Cancer Institute
Buffalo New York, 14263, 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
Ralph Lauren Center for Cancer Care and Prevention
New York New York, 10035, 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 Hospital
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
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Miriam Hospital
Providence Rhode Island, 02906, 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 and State Agricultural College
Burlington Vermont, 05405, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

156

Study ID:

NCT00453154

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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