HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT00980239
- Phase
- PHASE1
- Status
- Completed
Conditions
- Advanced Cancer
- Liver Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Irinotecan — DRUGStarting dose of 35 mg/m\^2 given through the catheter into your liver artery (hepatic artery infusion - HAI), continuously for 72 hours (Days 1 through 2 of each cycle).
- Bevacizumab — DRUG10 mg/Kg by vein on Days 1 and 15 of every 28 day cycle, over 90 minutes first cycle and over 30-60 minutes subsequent cycles.
- Oxaliplatin — DRUGStarting dose 60 mg/m\^2 by vein over 2 hours on Days 1 and 15 of every cycle.
- Cetuximab — DRUG500 mg/m\^2 by vein on Days 1 and 15 of every cycle. The first time given over 2 hours, all other cycles over 1 hour.
Study Details
The goal of this clinical research study is to learn the highest tolerable dose of irinotecan that can be given directly into the liver, in combination with other drugs given by vein. The other drug combinations given by vein include bevacizumab alone, bevacizumab plus oxaliplatin, and bevacizumab plus cetuximab. This will be tested in patients with advanced solid tumors that have spread to the liver. The safety of these drug combinations will also be studied.
Key Dates
- Start date
- Sep 30, 2009
- Status verified
- Nov 2015
- Primary completion
- Aug 31, 2015
- Completion
- Aug 31, 2015
Study Design
- Enrollment
- 115 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Group 1Group 1 = Irinotecan + Bevacizumab
- Experimental: Group 2Group 2 = Irinotecan, Bevacizumab + Oxaliplatin
- Experimental: Group 3Group 3 = Irinotecan, Bevacizumab + Cetuximab
Primary Outcome Measure
Maximum Tolerated Doses (MTDs) [ Time Frame: Evaulated with each 28 day cycle ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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