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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Extensive Stage Lung Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT00453154

Run by

National Cancer Institute (NCI)

People needed

156

Starts

2007-03-15

Expected to finish

2015-08-20

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• 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
• Arroyo Grande Community — Arroyo Grande, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.