Clinical trial · Interventional
Oxaliplatin, Irinotecan, and Capecitabine in Treating Patients With Advanced or Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Oxaliplatin, Irinotecan, and Capecitabine as a Combination Regimen for First-Line Treatment of Advanced or Metastatic Colorectal Cancer
NCT00217711CI-TRIAL-00007066completedPhase 1 / Phase 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, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine when given together with oxaliplatin and irinotecan and to see how well they work in treating patients with advanced or metastatic colorectal cancer that cannot be removed by surgery.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Oxaliplatin, Irinotecan, and Capecitabine
- interventionNames
- Drug: Capecitabine
- Drug: irinotecan hydrochloride
- Drug: oxaliplatin
Primary outcomes (2)
- measure
- capecitabine + oxaliplatin + irinotecan dose finding
- timeFrame
- 30 days
- description
- Determine the maximum tolerated dose and recommended phase II dose of capecitabine administered in combination with oxaliplatin and irinotecan in patients with unresectable advanced or metastatic colorectal cancer. (Phase I)
- measure
- Efficacy of Oxaliplatin, Irinotecan, and Capecitabine
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed unresectable advanced or metastatic colorectal cancer * Measurable disease (phase II only) * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI * No presence or history of CNS metastases PATIENT CHARACTERISTICS: Age * 18 to 70 Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.25 times upper limit of normal (ULN) (1.5 times ULN if liver metastases are present) * AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present) Renal * Creatinine clearance \> 60 mL/min Cardiovascular * No New York Heart Association class III-IV congestive heart failure * No symptomatic coronary artery disease * No uncontrolled cardiac arrhythmia * No myocardial infarction within the past year * No other clinically significant cardiac disease Immunologic * No active autoimmune disease * No uncontrolled infection * No prior severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil * No known hypersensitivity to any component of study drugs Other * Not pregnant or nursing * Negative pregnancy test * Patients must use effective contraception during and for 1 year after study participation * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer * No peripheral neuropathy \> grade 1 of any origin (e.g., alcohol or diabetes) * No nausea, vomiting, or malabsorption syndrome that would preclude ingestion or absorption of oral medication * No psychiatric disability that would preclude study compliance * No uncontrolled diabetes * No other serious underlying medical condition that would preclude study participation * No known dihydropyrimidine dehydrogenase deficiency PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic hematopoietic growth factors Chemotherapy * More than 6 months since prior adjuvant fluoropyrimidine chemotherapy * No other prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No concurrent radiotherapy * Concurrent radiotherapy of a single painful lesion allowed Surgery * Not specified Other * More than 30 days since prior clinical trial participation * No other concurrent experimental drugs * No other concurrent anticancer therapy * No concurrent sorivudine or its chemically-related analogues (e.g., lamivudine)
References
Publications (1)
- RESULTvon Moos R, Roth A, Ruhstaller T, Widmer L, Uhlmann C, Cathomas R, Koberle D, Simcock M, Lanz D, Popescu R. Oxaliplatin, irinotecan and capecitabine (OCX) for first-line treatment of advanced/metastatic colorectal cancer: a phase I trial (SAKK 41/03). Onkologie. 2010;33(6):295-9. doi: 10.1159/000313598. Epub 2010 May 14. PMID 20523092