Clinical trial · Interventional
Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer
NCT00066274CI-TRIAL-00050393completedPhase 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. Giving the drugs in different combinations may kill more tumor cells. PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFIRI regimen | Drug | FOLFIRI Regimen | ALIAS |
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal carcinoma * Metastatic disease * Not amenable to surgery * Unidimensionally measurable disease * No bone metastases * No brain metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * WHO 0-2 Life expectancy * At least 12 weeks Hematopoietic * Neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than 1.25 times upper limit of normal (ULN) (1.5 times ULN if hepatic metastases are present) * SGPT and SGOT no greater than 3 times ULN (5 times ULN if hepatic metastases are present) Renal * Creatinine no greater than 1.25 times ULN Cardiac * No concurrent cardiac abnormalities that would preclude study therapy Pulmonary * No concurrent pulmonary abnormalities that would preclude study therapy Other * Not pregnant or nursing * Fertile patients must use effective contraception * No chronic enteropathy * No other prior cancer within the past 5 years except carcinoma in situ of the cervix or curatively treated basal cell skin cancer * No concurrent severe uncontrolled infection * No obstruction or partial obstruction that would interfere with study therapy * No psychological, social, familial, or geographical situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer biological response modifiers Chemotherapy * No prior chemotherapy (except adjuvant chemotherapy completed more than 6 months ago) * No prior irinotecan * No prior oxaliplatin * No other concurrent chemotherapy Endocrine therapy * No concurrent anticancer hormonal therapy Radiotherapy * At least 4 weeks since prior pelvic radiotherapy * No prior abdominopelvic radiotherapy Surgery * At least 4 weeks since prior surgery * No prior extensive intestinal resection (i.e., more than 1 prior hemicolectomy or extensive resection of the small intestines) Other * No other concurrent experimental medication * No other concurrent anticancer therapy
References
Publications (1)
- RESULTBecouarn Y, Senesse P, Thezenas S, Boucher E, Adenis A, Cany L, Jacob JH, Cvitkovic F, Montoto-Grillot C, Ychou M; Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer. A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5 FU2 + irinotecan or LV5 FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer. Ann Oncol. 2007 Dec;18(12):2000-5. doi: 10.1093/annonc/mdm379. Epub 2007 Sep 4. PMID 17785765