A Phase 1b Study With Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in First-line, Advanced Non-small Cell Lung Cancer (NSCLC)
|Non-small Cell Lung Cancer||Drug: M200 (Volociximab), Carboplatin, Paclitaxel, Bevacizumab||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1b Trial Evaluating the Safety of Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in Subjects With Previously Untreated Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)|
- To determine the maximum tolerated dose (MTD) of volociximab given at different doses in combination with carboplatin, paclitaxel, and bevacizumab. [ Time Frame: Dose Limiting Toxicities (DLT) will be assessed during the first treatment cycle for each cohort ]
- 1) Pharmacokinetics of volociximab 2) Efficacy of volociximab in combination with carboplatin/paclitaxel and bevacizumab. [ Time Frame: Throughout study period ]
|Study Start Date:||April 2008|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Escalating doses of volociximab at 10, 20, and 30 mg/kg with carboplatin, paclitaxel, and bevacizumab
Drug: M200 (Volociximab), Carboplatin, Paclitaxel, Bevacizumab
Volociximab will be administered via IV infusion once every three week at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels on Day 8 of the first cycle. Volociximab will be given for up to 6 cycles (3 weeks/cycle). Subjects who have stable disease or better and subjects who have disease that is not progressing at the end of 6 cycles may continue to receive volociximab alone until disease progression. Carboplatin is administered via IV infusion and dosed based on the Calvert formula (with a target area AUC of 6 mg/mL/min) for up to 6 cycles (3 weeks/cycle). Paclitaxel is administered via IV infusion and dosed at 200 mg/m2 for up to 6 cycles (3 weeks/cycle). All four drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.
Other Name: Volociximab (M200)
Phase 1b, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of volociximab in combination with C/P + B in subjects with previously untreated Stage IIIB/IV non-squamous NSCLC.
Subjects will be treated with the C/P + B + volociximab (V)combination for a total of 6 cycles (3 weeks/cycle). Subjects with stable disease (SD)or better per Response Evaluation Criteria in Solid Tumors (RECIST)after the 6th cycle of combination treatment (C/P + B + V) will be considered for further treatment in a maintenance phase with B + V at the same dose until subject withdrawal from treatment.
Volociximab will be administered at doses ranging from 10 to 30 mg/kg every 3 weeks. Paclitaxel, carboplatin, and bevacizumab will be administered at their registered doses for this combination.
Follow up for each subject will extend over a 90-day period following the last dose of volociximab. End of study is defined as 90 days after the last dose of volociximab for the last subject treated in the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666692
|United States, Maryland|
|Site Reference ID/Investigator# 70354|
|Bethesda, Maryland, United States, 20817-7847|
|United States, Pennsylvania|
|Site Reference ID/Investigator# 70333|
|Hershey, Pennsylvania, United States, 17033-0850|
|United States, South Carolina|
|Site Reference ID/Investigator# 70355|
|Greenville, South Carolina, United States, 29605|
|United States, Washington|
|Site Reference ID/Investigator# 70353|
|Yakima, Washington, United States, 98902|
|Study Director:||Mihail Obrocea, MD||Abbott|