Erlotinib in Combination With Cetuximab
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT00895362
- Phase
- PHASE1
- Status
- Completed
Conditions
- Advanced Cancers
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Erlotinib — DRUGStarting dose 100 mg by mouth 1 time every day for 28-day cycle (Pediatric starting dose 50 mg).
- Cetuximab — DRUGLoading dose of 200 mg/m\^2 (maintenance 125 mg/m\^2) by vein 1 day every week of 28-day cycle, on Days 1, 8, 15 and 22. First dose given over 2 hours and over 1 hour each subsequent time.
Study Details
The goal of this clinical research study is to find the highest tolerable dose of Tarceva (erlotinib hydrochloride) that can safely be given in combination with Erbitux (cetuximab). The safety of this drug combination will also be studied.
Key Dates
- First listed
- May 8, 2009
- Start date
- Apr 30, 2009
- Status verified
- Jul 2015
- Primary completion
- Jul 31, 2015
Study Design
- Enrollment
- 65 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Erlotinib + CetuximabErlotinib in Combination with Cetuximab
Primary Outcome Measure
Maximum Tolerated Dose (MTD) of Erlotinib in Combination with Cetuximab [ Time Frame: 28 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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