Clinical trial · Observational
Irinotecan in Treating Patients With Colorectal Cancer
UGT1A1 Polymorphism in Patients With Colorectal Cancer Treated With CPT-11 (Irinotecan)
NCT00003843CI-TRIAL-00016879terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to poor accrual
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. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have colorectal cancer.
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 |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| mutation analysis | Genetic | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven advanced or disseminated colorectal cancer * Progressive disease on fluorouracil based chemotherapy OR * Recurrence of disease within 12 months of adjuvant therapy with fluorouracil * No known CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Granulocyte count greater than 1500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT no greater than 3 times ULN (no greater than 5 times ULN if liver involved) Renal: * Creatinine no greater than 2.0 mg/dL * Calcium no greater than 12.0 mg/dL Cardiovascular: * No myocardial infarction within past 6 months * No congestive heart failure requiring therapy Neurologic: * No severe psychiatric disorders * No history of seizures Other: * No active or uncontrolled infection * HIV negative * No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No uncontrolled diabetes mellitus (random blood sugar 200 mg/dL or greater) * No other severe concurrent disease * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * Prior oxaliplatin allowed * No prior irinotecan or topotecan Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
References
Publications (0)
Data not yet available
No reference posted for this study.