A Comparison of Two Doses of Pemetrexed in Patients Who Have Lung Cancer

Sponsor
Eli Lilly and Company
Study ID
NCT00078260
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pemetrexed — DRUG
    A: 500 mg/m2, IV, q 21 days until disease progression B: 900 mg/m2, IV, q 21 days until disease progression

Study Details

The purposes of this study are to determine: * the safety of pemetrexed and any side effects that might be associated with it * how much pemetrexed should be given to patients. It is possible that information collected during this study will be analyzed by the Sponsor in the future to evaluate pemetrexed for other possible uses or for other medical or scientific purposes other than those currently proposed. Although pemetrexed has been shown to be effective in some patients with non-small-cell lung cancer, pemetrexed might not have beneficial effects for all patients.

Key Dates

Start date
Dec 31, 2003
Status verified
Sep 2019
Primary completion
Oct 31, 2006
Completion
Apr 30, 2008

Study Design

Enrollment
589 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
  • Experimental: B

Primary Outcome Measure

Overall survival [ Time Frame: baseline to date of death from any cause ]

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