Topotecan & Bevacizumab in Treating Patients With Stage IIIB or Stage IV

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00365547
Study type	Interventional
Source	Masonic Cancer Center, University of Minnesota
Contact
Status	Completed
Phase	Phase 2
Start date	September 2006
Completion date	September 2011

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms