Clinical trial · Interventional
Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
CWRU 1296: Biochemical and Pharmacokinetic Predictors of Colon Cancer Response to a Topoisomerase I Directed Treatment With Irinotecan
NCT00002933CI-TRIAL-00046181completedPhase 2ClinicalTrials.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. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have metastatic or recurrent 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Effectiveness of irinotecan in treating patients who have metastatic or recurrent colorectal cancer.
- timeFrame
- Starting dose weekly for 4 weeks followed by 2 weeks of rest. Treatment continues in the absence of disease progression or unacceptable toxicity. Tumor status is reassessed every 12 weeks during study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed metastatic or recurrent adenocarcinoma of the colon or rectum that is incurable by surgery or radiation therapy A metastatic lesion in the liver or lung should be evaluated for definitive surgical treatment before being considered for this study Measurable disease required Elevated CEA, hepatomegaly ascites, pleural effusion, positive nuclear scan or bone scan, or poorly defined pelvic or abdominal mass are NOT considered measurable disease Must have measurable disease outside the radiation port or progression of disease within a previously radiated area Must be eligible for a biopsy of a malignant lesion No ascites that are detectable on physical exam No brain metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: WBC at least 4,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.2 mg/dL SGOT less than 4 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL or Creatinine clearance at least 60 mL/min Other: No history of any other malignancy except curatively treated nonmelanoma skin cancer and carcinoma in situ of the cervix No active infection or other serious medical conditions deemed unacceptable Negative pregnancy test Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced disease Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy Surgery: At least 3 weeks since any surgical procedure
References
Publications (0)
Data not yet available
No reference posted for this study.