Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00080951
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy as first-line therapy in treating patients who have metastatic colorectal cancer.

Key Dates

Start date
Mar 31, 2004
Status verified
Dec 2016
Primary completion
Apr 30, 2005
Completion
Feb 29, 2008

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: irinotecan + oxaliplatin + leucovorin + fluorouracil
    Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each chemotherapy course, and at the end of treatment. Patients are followed every 3 months until 5 years after registration.

Primary Outcome Measure

tumor response rate [ Time Frame: Up to 5 years ]

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