Combination Chemotherapy in Treating Patients With Stage III Colon Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00003835
Phase
PHASE3
Status
Completed

Conditions

  • Adenocarcinoma of the Colon
  • Stage III Colon Cancer

Eligibility Criteria

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

Interventions

  • leucovorin calcium — DRUG
    Given IV
  • fluorouracil — DRUG
    Given IV
  • irinotecan hydrochloride — DRUG
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

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 stage III colon cancer. Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colon cancer.

Key Dates

Start date
May 31, 1999
Status verified
Oct 2013
Primary completion
Aug 31, 2007

Study Design

Enrollment
1,260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (leucovorin calcium and fluorouracil)
    Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV beginning 1 hour into leucovorin calcium infusion weekly for 6 weeks. Treatment is repeated every 8 weeks for 4 courses.
  • Experimental: Arm II (leucovorin calcium, fluorouracil, irinotrcan)
    Patients receive irinotecan IV over 90 minutes, followed by leucovorin calcium IV, then followed by fluorouracil IV weekly for 4 weeks. Treatment is repeated every 6 weeks for 5 courses

Primary Outcome Measure

Time to recurrence [ Time Frame: From time of resection until documented disease progression, assessed up to 6 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer and Leukemia Group BChicagoIllinois60606-

Find similar trials in Chicago, IL

By research site
Cancer and Leukemia Group B· Chicago, IL

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