Trials / Completed
CompletedNCT00006103
Combination Chemotherapy in Treating Patients With Colorectal Cancer
Interracial Study of CPT-11 (Irinotecan) Pharmacokinetics in 5-Fluorouracil Refractory Colorectal Cancer: A Population Pharmacokinetic/Pharmacodynamic Study of CPT-11
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if the effectiveness of irinotecan combined with fluorouracil in treating colorectal cancer varies depending on the patient's racial background. PURPOSE: Phase III trial to study the effectiveness of irinotecan combined with fluorouracil in treating patients from different racial backgrounds who have colorectal cancer that is advanced, recurrent, metastatic or has not responded to treatment with fluorouracil.
Detailed description
OBJECTIVES: * Determine the interracial differences in the pharmacokinetics of irinotecan in combination with fluorouracil in terms of SN-38 glucuronidation and biliary index, and gastrointestinal (GI) toxicity in patients with metastatic, locally advanced, or recurrent colorectal cancer. * Determine if there is a significant relationship between UGT1A1 genotype (promoter and/or coding region mutation) and CYP3A4 promoter genotype, vs GI toxicity, bone marrow toxicity, and pharmacokinetics of irinotecan in this patient population. OUTLINE: Patients are stratified according to race (Asian or Pacific Islander vs black vs Hispanic vs white). Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for a total of 5 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 400 patients (100 per stratum) will be accrued for this study within 3 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | fluorouracil | |
| DRUG | irinotecan hydrochloride | |
| DRUG | leucovorin calcium |
Timeline
- Start date
- 2000-07-01
- Primary completion
- 2002-04-01
- Completion
- 2002-04-01
- First posted
- 2003-09-03
- Last updated
- 2016-07-06
Source: ClinicalTrials.gov record NCT00006103. Inclusion in this directory is not an endorsement.