Clinical trial · Interventional
Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
A Multicenter, Open-Label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic Colorectal Carcinoma
NCT00012389CI-TRIAL-00013133completedPhase 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 irinotecan is more effective with or without oxaliplatin in treating metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum * Metastatic or recurrent disease that is not amenable to potentially curative treatment * Progressive or recurrent disease during or after 1, and only 1, regimen of fluorouracil with or without leucovorin calcium or during or within 6 months after adjuvant chemotherapy with fluorouracil and leucovorin calcium PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT/SGPT no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No unstable angina * No New York Heart Association class III or IV congestive heart failure * No serious cardiac arrhythmia * No history of cardiac toxicity from fluorouracil/leucovorin calcium * No myocardial infarction within past 6 months Pulmonary: * No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: * No uncontrolled predisposing colonic or small bowel disorder * No prior chronic enteropathy, chronic diarrhea, or unresolved bowel obstruction/subobstruction * No diabetes * No active infection * No known current peripheral neuropathy * No concurrent active cancer except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No intolerance of appropriate antiemetics * No history of anaphylaxis or potential intolerance to atropine sulfate or loperamide * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy * No prior irinotecan or oxaliplatin * No other prior chemotherapy agents except fluorouracil with or without leucovorin calcium as first-line therapy for metastatic disease or in the adjuvant setting Endocrine therapy: * Not specified Radiotherapy: * Prior radiotherapy to non-target lesions allowed * No prior radiotherapy to target lesions unless disease progression is documented within the radiation port * At least 3 weeks since prior radiotherapy Surgery: * At least 4 weeks since prior major surgical procedure and recovered * Prior surgery for primary tumor or metastasis allowed Other: * At least 30 days since prior investigational drug * No concurrent investigational agents
References
Publications (1)
- RESULTHaller DG, Rothenberg ML, Wong AO, Koralewski PM, Miller WH Jr, Bodoky G, Habboubi N, Garay C, Olivatto LO. Oxaliplatin plus irinotecan compared with irinotecan alone as second-line treatment after single-agent fluoropyrimidine therapy for metastatic colorectal carcinoma. J Clin Oncol. 2008 Oct 1;26(28):4544-50. doi: 10.1200/JCO.2008.17.1249. PMID 18824706