Clinical trial · Interventional
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
NCT00006103CI-TRIAL-00022850completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- irinotecan + leucovorin + fluorouracil
- description
- 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.
- interventionNames
- Drug: fluorouracil
- Drug: irinotecan hydrochloride
- Drug: leucovorin calcium
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- Up to 10 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * Metastatic, locally advanced, or recurrent disease * Patients must have at least 2 generations (parents and grandparents) who belong to one of the following racial groups: * Asian or Pacific Islander (e.g., China, Japan, Korea, the Philippine Islands, or Samoa) * Black (originating from the black racial groups of Africa) * Hispanic (originating from Mexico, Puerto Rico, Cuba, Central or South America, or other Spanish culture) * White (originating from the peoples of Europe, North Africa, or the Middle East) * No patients with parents or grandparents of mixed race or race other than that of the patient PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * CTC 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST no greater than 3 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior adjuvant fluorouracil allowed if relapse occurred at least 6 months after completion of fluorouracil * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No prior irinotecan * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormones except steroids for adrenal failure, hormones for nondisease related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic * No concurrent prednisone Radiotherapy: * At least 4 weeks since prior radiotherapy (except to bone or soft tissue involving less than 25% of bone marrow) * No concurrent radiotherapy Surgery: * At least 4 weeks since prior major surgery Other: * No concurrent phenobarbital, valproate, or cyclosporine * None of the following concurrently during first course of therapy: * Macrolide antibiotics (e.g., azithromycin, erythromycin, clarithromycin, troleandomycin, dapsone) * Azole antibiotics (e.g., fuconazole, miconazole, itraconazole, ketoconazole) * Triazobenzodiazepines (e.g., alprazolam, midazolam, triazolam) * Antidepressants (e.g., fluoxetine, setraline hydrochloride, fluoxamine, nefazodone hydrochloride) * Quinolone antimicrobials (e.g., ciprofloxacin, ofloxacin) * Imidazole antibiotics (e.g., clotrimazole) * Anti-ulcer medications (e.g., omeprazole, lansoprazole) * Ethinyl estradiol * Diltiazem * Cimetidine hydrochloride * Cisapride * Terfenadine * Rifampin * Glucocorticoids * Antiepileptics * Grapefruit juice
References
Publications (0)
Data not yet available
No reference posted for this study.