Clinical trial · Interventional
Capecitabine, Irinotecan, and Oxaliplatin in Treating Patients With Metastatic Cancer
Phase I Study Evaluating the Feasibility of Chemotherapy With Capecitabine, Irinotecan, and Oxaliplatin in Patients With Metastatic Carcinoma
- 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 capecitabine, irinotecan, and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with irinotecan and oxaliplatin in treating patients with metastatic 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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose of capecitabine
- measure
- Dose-limiting toxicities
Secondary outcomes (6)
- measure
- Recommended phase II dose of capecitabine
- measure
- Toxicity profile
- measure
- Objective response
- measure
- Duration of response
- measure
- Time to disease progression
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically confirmed metastatic carcinoma * Primary tumor may be present * No curative therapy available or the patient achieved no response to prior standard therapy * Nonresectable metastatic disease * Measurable, evaluable, or nonevaluable disease Exclusion criteria: * Symptomatic brain metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Inclusion criteria: * WHO performance status 0-2 * Life expectancy ≥ 12 weeks * ANC ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Bilirubin \< 1.25 times upper limit of normal (ULN) (1.5 times ULN if due to liver metastases) * Transaminases \< 3 times ULN (5 times ULN if due to liver metastases) * Alkaline phosphatase ≤ 3 times ULN * Creatinine ≤ 1.5 times ULN * Creatinine clearance \> 30 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception Exclusion criteria: * Severe concurrent infection or major organ failure, including any of the following: * Cardiac disease * Diabetic decompensation * Clinically active infection * Prior severe toxicity from fluorouracil * Intestinal obstruction or subobstruction * Malabsorption syndrome * Peripheral neuropathy * Uncontrolled epilepsy PRIOR CONCURRENT THERAPY: Inclusion criteria: * At least 4-6 weeks since prior anticancer chemotherapy Exclusions criteria: * Prior chemotherapy with any of the study drugs * Prior major intestinal resection * Concurrent participation in another clinical study
References
Publications (0)
Data not yet available