Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer

Sponsor
Hokkaido Gastrointestinal Cancer Study Group
Study ID
NCT00209625
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • irinotecan — DRUG
  • leucovorin — DRUG
  • fluorouracil — DRUG

Study Details

We performed a phase I/II study of CPT-11/5FU/l-LV in advanced colorectal cancer, to determine the optimal dose of CPT-11 and to estimate the safety and efficacy of this regimen

Key Dates

Start date
Apr 30, 2000
Status verified
Apr 2000
Completion
Nov 30, 2004

Study Design

Enrollment
23 participants
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

objective tumor response

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