Clinical Trial: Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients With Advanced Colorectal Carcinoma Previously Treated With 5

Brief Summary: Randomized phase III trial to compare the effectiveness of irinotecan with that of combination chemotherapy in treating patients who have advanced colorectal cancer that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for colorectal cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Determine whether in advanced colorectal carcinoma patients who have been previously treated with 5-FU, the overall survival of patients treated with OXAL + 5-FU + CF followed by CPT-11 is equivalent to the survival of patients treated with CPT-11 followed by OXAL + 5-FU + CF.

SECONDARY OBJECTIVES:

I. Evaluation of time to tumor progression, time to treatment failure, toxicity of treatment, and overall response rate in patients treated with these two regimens.

II. To compare quality-of-life measurements patients treated with these two regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (ECOG 0-1 vs 2), primary indicator lesion (hepatic vs pulmonary vs other), age (less than 65 vs at least 65 years), alkaline phosphatase (less than 2 vs at least 2 times ULN), fluorouracil failure (adjuvant vs metastatic), and membership (intergroup vs expanded participation project). Patients are randomized to one of two treatment arms.

ARM I: Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on days 1 and 2, and fluorouracil IV bolus followed by IV infusion over 22 hours on days 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Patients who experience progression or toxicity on the initial regimen may crossov
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Overall survival [ Time Frame: At least 6 months ]

The primary analysis for this trial will be based on a one-sided Generalized Wilcoxon test.


Original Primary Outcome:

Current Secondary Outcome:

  • Time-to-tumor progression [ Time Frame: Time from start of therapy to documentation of disease progression, assessed up to 3 years ]
  • Time-to-treatment failure [ Time Frame: Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, refusal, or death, assessed up to 3 years ]
  • Objective tumor response rate (CR or PR) in patients with measureable disease [ Time Frame: At least 4 weeks ]
  • Toxicity and dose intensity [ Time Frame: Up to 3 years ]
  • Quality of life [ Time Frame: Up to 3 years ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: April 6, 2000
Date Started: November 1999
Date Completion:
Last Updated: May 1, 2013
Last Verified: May 2013