Clinical trial · Interventional
Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients With Advanced Colorectal Carcinoma Previously Treated With 5-FU
NCT00005036CI-TRIAL-00010192completedPhase 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)
Randomized phase III trial to compare the effectiveness of irinotecan with that of combination chemotherapy in treating patients who have advanced colorectal cancer that has not responded to previous treatment. 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 colorectal cancer.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucinous Adenocarcinoma of the Colon | Colon Mucinous Adenocarcinoma | ALIAS | 0.90 |
| Mucinous Adenocarcinoma of the Rectum | Rectal Mucinous Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Signet Ring Adenocarcinoma of the Colon | — | UNRESOLVED | — |
| Signet Ring Adenocarcinoma of the Rectum | Rectal Signet Ring Cell Adenocarcinoma | ALIAS | 0.90 |
| Stage IIIA Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (irinotecan)
- description
- Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: irinotecan hydrochloride
- Procedure: quality-of-life assessment
- type
- EXPERIMENTAL
- label
- Arm II (oxalipatin, fluorouracil, leucovorin calcium)
- description
- Patients receive oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on days 1 and 2, and fluorouracil IV bolus followed by IV infusion over 22 hours on days 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: oxaliplatin
- Drug: leucovorin calcium
- Drug: fluorouracil
- Procedure: quality-of-life assessment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed locally advanced, locally recurrent,or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy * Progressive disease following: * One prior fluorouracil based chemotherapy regimen for metastatic disease * Failure during or within 6 months after fluorouracil based adjuvant therapy * Measurable or evaluable disease * No CNS metastases or carcinomatous meningitis * Performance status - ECOG 0-2 * At least 12 weeks * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL (transfusion allowed) * Bilirubin no greater than 1.5 mg/dL * AST no greater than 5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN * Creatinine no greater than 1.5 times ULN * No uncontrolled high blood pressure * No unstable angina * No symptomatic congestive heart failure * No myocardial infarction with the past 6 months * No serious uncontrolled cardiac arrhythmias * No New York Heart Association class III or IV heart disease * No pleural effusion or ascites that cause respiratory compromise (e.g., dyspnea grade 2 or greater) * No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung * Not pregnant or nursing * Fertile patients must use effective contraception * Fluent in English * No active or uncontrolled infection * No other prior malignancy within the past 5 years, except: * Adequately treated basal or squamous cell skin cancer * Adequately treated noninvasive carcinomas * No sensory neuropathy grade 2 or greater * No uncontrolled colonic or small bowel disorders (greater than 3 loose stools daily) * No concurrent sargramostim (GM-CSF) * At least 4 weeks since prior chemotherapy and recovered * No more than 1 prior chemotherapy regimen for advanced colorectal cancer * No prior irinotecan or other camptothecin derivative (e.g., topotecan) * No prior oxaliplatin * No other concurrent investigational chemotherapy agents * At least 4 weeks since prior major radiotherapy * No prior radiotherapy to greater than 25% of bone marrow * At least 4 weeks since prior major surgery and recovered * At least 2 weeks since prior minor surgery and recovered
References
Publications (0)
Data not yet available
No reference posted for this study.