Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00005036
Phase
PHASE3
Status
Completed

Conditions

  • Mucinous Adenocarcinoma of the Colon
  • Mucinous Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Signet Ring Adenocarcinoma of the Colon
  • Signet Ring Adenocarcinoma of the Rectum
  • Stage IIIA Colon Cancer
  • Stage IIIA Rectal Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Rectal Cancer
  • Stage IIIC Colon Cancer
  • Stage IIIC Rectal Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer

Eligibility Criteria

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

Interventions

  • irinotecan hydrochloride — DRUG
    Given IV
  • oxaliplatin — DRUG
    Given IV
  • leucovorin calcium — DRUG
    Given IV
  • fluorouracil — DRUG
    Given IV
  • quality-of-life assessment — PROCEDURE
    Ancillary studies

Study Details

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.

Key Dates

Start date
Nov 30, 1999
Status verified
May 2013
Primary completion
Dec 31, 2006

Study Design

Enrollment
560 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (irinotecan)
    Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (oxalipatin, fluorouracil, leucovorin calcium)
    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.

Primary Outcome Measure

Overall survival [ Time Frame: At least 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
North Central Cancer Treatment GroupRochesterMinnesota55905-

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By research site
North Central Cancer Treatment Group· Rochester, MN