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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.
- Determine the safety and feasibility of combining pemetrexed disodium with erlotinib hydrochloride in patients with advanced non-small lung cancer (NSCLC) or other solid tumors. (Phase I)
- Determine the response rate in patients with NSCLC treated with pemetrexed disodium in combination with erlotinib hydrochloride. (Phase II)
- Compare toxicity differences between different schedules of pemetrexed disodium and erlotinib hydrochloride. (Phase I)
- Determine the maximum tolerated dose (MTD) of 2 different schedules of pemetrexed disodium and erlotinib hydrochloride. (Phase I)
- Determine, preliminarily, the efficacy of the combination of pemetrexed disodium and erlotinib hydrochloride in patients with advanced solid tumors. (Phase I)
- Assess the overall survival and progression-free survival. (Phase II)
- Determine the frequency and severity of toxicities associated with the administration of pemetrexed disodium and erlotinib hydrochloride. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II open-label study.
- Phase I: Patients are assigned to 1 of 2 treatment groups in an alternating fashion. Once accrual to the first dose level in group 1 is complete, group 2 will open for accrual to its first dose level.
- Group 1: Patients 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.
- Group 2: Patients 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.
In both groups, patients may continue to receive erlotinib hydrochloride alone after completion of 6 courses of erlotinib hydrochloride in combination with pemetrexed disodium.
In both groups, cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride and pemetrexed disodium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive pemetrexed disodium at the MTD and erlotinib hydrochloride at the MTD as in group 1 or 2 (whichever is more favorable).
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
erlotinib hydrochloride, pemetrexed disodium
University of California Davis Cancer Center
University of California, Davis
Published on BioPortfolio: 2014-07-23T21:35:09-0400
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