Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT00079040
- Phase
- PHASE2
- Status
- Completed
Conditions
- Extensive Stage Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- cisplatin — DRUGGiven IV
- etoposide — DRUGGiven IV
- bevacizumab — BIOLOGICALGiven IV
- laboratory biomarker analysis — OTHERCorrelative studies
Study Details
This phase II trial is studying how well giving cisplatin and etoposide together with bevacizumab works in treating patients with previously untreated extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as 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 deliver tumor-killing substances to them. Giving chemotherapy with a monoclonal antibody may kill more tumor cells.
Key Dates
- First listed
- Mar 9, 2004
- Start date
- Jan 31, 2006
- Status verified
- Dec 2012
- Primary completion
- Jan 31, 2009
- Completion
- Jan 31, 2009
Study Design
- Enrollment
- 65 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (cisplatin, etoposide, bevacizumab)Chemotherapy: Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab therapy: Beginning concurrently with chemotherapy, patients receive bevacizumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Percentage of Participants Alive and Progression-free (PF) at 6 Months [ Time Frame: 6 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Eastern Cooperative Oncology Group | Boston | Massachusetts | 02215 | - |
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