Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- Stanford University
- Study ID
- NCT00323869
- Phase
- PHASE2
- Status
- Completed
Conditions
- Lung Cancer
- Non-small Cell Lung Cancer (NSCLC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — DRUGMurine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody
- Gemcitabine — DRUGNucleoside analog
- Carboplatin — DRUGAlkylating agent
Study Details
A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).
Key Dates
- First listed
- May 10, 2006
- Start date
- Jun 30, 2006
- Status verified
- Jul 2016
- Primary completion
- Oct 31, 2013
- Completion
- Oct 31, 2013
Study Design
- Enrollment
- 48 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Bevacizumab + carboplatin + gemcitabineBevacizumab in combination with carboplatin and gemcitabine: •Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles. Carboplatin was administered before the gemcitabine infusion: •Gemcitabine, administered 1000 mg/m² IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles Bevacizumab was administered 1 hour after end of all chemotherapy infusions: •Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity
Primary Outcome Measure
Progression-free Survival (PFS) [ Time Frame: 18 months ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| VA Palo Alto Healthcare System | Palo Alto | California | 94304-1290 | - |
| Santa Clara Valley Medical Center | San Jose | California | 95128 | - |
| Stanford University School of Medicine | Stanford | California | 94305 | - |
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