Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Colorectal Cancer
Time Finding Study of Chronomodulated Irinotecan, 5 Fluorouracil, Leucovorin and Oxaliplatin as First or Second Chemotherapy Line Against Metastatic Colorectal Cancer
NCT00039208CI-TRIAL-00007415completedPhase 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 drugs at the time of day that allows for the best drug response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Randomized phase II trial to determine the best time to give irinotecan combined with fluorouracil, leucovorin, and oxaliplatin 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy
Secondary outcomes (6)
- measure
- Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy, excluding those who stopped prior to course 3 for reasons other than toxicity
- measure
- Peak delivery time for CPT11 activity over the first 3 courses
- measure
- Peak delivery time for CPT11 tolerability and efficacy over the first 6 courses
- measure
- Severe toxic events assessed by CTC v2.0 after each course of chemotherapy
- measure
- Progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal cancer * Unresectable metastatic or locoregional disease * At least 1 measurable lesion outside a previously irradiated area or an area treated with physical devices (e.g., cryotherapy, laser, or thermoablation) * No prior enrollment in EORTC-05963 * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Neutrophil count greater than 2,000/mm\^3 * Platelet count at least 90,000/mm\^3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) Renal: * Creatinine no greater than 1.5 times ULN * No uncontrolled hypercalcemia Cardiovascular: * No overt cardiac disease Pulmonary: * No severe respiratory illness Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Male patients must use effective barrier contraception during and for up to 6 months after study * No baseline diarrhea greater than grade I (must have less than 4 stools per 24 hours) * No prior grade III or IV toxicity related to irinotecan * No sensory or motor neuropathy with functional impairment * No prior hypersensitivity to any study drug * No other primary tumor except basal cell skin cancer or carcinoma in situ of the cervix * No uncontrolled infectious or chronic disease * No psychological, familial, sociological, or geographical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent prophylactic growth factor therapy Chemotherapy: * At least 1 month since prior chemotherapy * No prior irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as combination therapy * Other prior therapy containing irinotecan and/or oxaliplatin allowed * No more than 1 prior chemotherapy regimen for metastatic or locoregional disease * Adjuvant chemotherapy considered first-line therapy if tumor relapsed within 6 months of completion of therapy Endocrine therapy: * No concurrent corticosteroids except for emergencies Radiotherapy: * See Disease Characteristics * Palliative radiotherapy for bone lesion allowed except for disease progression Surgery: * See Disease Characteristics
References
Publications (1)
- RESULTGarufi C, Focan C, Tumolo S, et al.: Time finding study of chronomodulated irinotecan (I), fluorouracil (F), leucovorin (L) and oxaliplatin (O) (chronoIFLO) against metastatic colorectal cancer: results from randomized EORTC 05011 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-2566, 2007.