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

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 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
  • Experimental: 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.

Primary Outcome Measure

Safety and feasibility (Phase I) [ Time Frame: October 2007 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Cancer CenterSacramentoCalifornia95817-

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