Spots Global Cancer Trial Database for Topotecan and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Did Not Respond to Previous Systemic Chemotherapy

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Trial Identification

Brief Title: Topotecan and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Did Not Respond to Previous Systemic Chemotherapy

Official Title: Phase II Clinical Study of Weekly Topotecan in Combination With Avastin™ in Patients With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Prior Systemic Chemotherapy

Study ID: NCT00365547

Conditions

Lung Cancer

Interventions

bevacizumab

topotecan hydrochloride

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as Avastin (bevacizumab), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving topotecan together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving topotecan together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer that did not respond to previous systemic chemotherapy.

Detailed Description: OBJECTIVES: Primary * Determine the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer treated with topotecan hydrochloride and bevacizumab who have failed prior systemic chemotherapy. Secondary * Determine the objective response rates in patients treated with this regimen. * Measure time-to-event efficacy variables, including time to objective tumor response (for responding patients), duration of response (for responding patients), time to treatment failure, and overall survival. * Characterize the quantitative and qualitative toxicities of this regimen in these patients. OUTLINE: Patients receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15 and Avastin (bevacizumab) IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 6 months from registration.