Pemetrexed Disodium and Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors
Part of paid clinical trials in Sacramento, California.
- Sponsor
- University of California, Davis
- Study ID
- NCT00387322
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Lung Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- erlotinib hydrochloride — DRUGGiven orally
- pemetrexed disodium — DRUGGiven IV
Study Details
RATIONALE: Pemetrexed disodium and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pemetrexed disodium together with erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of two different schedules of pemetrexed disodium and erlotinib and to see how well they work in treating patients with advanced non-small cell lung cancer or other solid tumors.
Key Dates
- First listed
- Oct 13, 2006
- Start date
- Mar 31, 2005
- Status verified
- Mar 2010
- Primary completion
- Oct 31, 2007
- Completion
- May 31, 2009
Study Design
- Enrollment
- 42 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Group 1Patients receive oral erlotinib hydrochloride once on days 2, 9, and 16 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of unacceptable toxicity or disease progression
- Experimental: Group 2Patients receive oral erlotinib hydrochloride once daily on days 2-16 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of unacceptable toxicity or disease progression.
Primary Outcome Measure
Safety and feasibility (Phase I) [ Time Frame: October 2007 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California Davis Cancer Center | Sacramento | California | 95817 | - |
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