Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer

Sponsor
AstraZeneca
Study ID
NCT00233623
Phase
PHASE2
Status
Withdrawn

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Iressa (Gefitinib) — DRUG
  • Irinotecan — DRUG
  • 5Fluorouracil — DRUG
  • Leucovorin — DRUG

Study Details

The aim of the study is to determine if Iressa added to chemotherapy with Irinotecan, 5Fluorouracil and Leucovorin can prolong the period of time without any disease worsening (Time to Progression) in patients with metastatic colorectal cancer.

Key Dates

Start date
Jul 31, 2004
Status verified
Jan 2011
Primary completion
Jan 31, 2006
Completion
Jan 31, 2006

Study Design

Enrollment
190 participants
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

Time to progression (6 months after Last patient in)

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