A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer

Sponsor
Eli Lilly and Company
Study ID
NCT00191984
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • pemetrexed — DRUG
    400 mg/m\^2, intravenous (IV), every 14 days x 12 cycles
  • irinotecan — DRUG
    180 mg/m\^2, intravenous (IV), every 14 days x 12 cycles

Study Details

A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.

Key Dates

Start date
Jun 30, 2004
Status verified
Jan 2011
Primary completion
Feb 28, 2007
Completion
May 31, 2008

Study Design

Enrollment
46 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pemetrexed + Irinotecan

Primary Outcome Measure

Best Overall Tumor Response [ Time Frame: baseline to measured progressive disease (up to 2 years follow-up) ]

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