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| ID | Type | Description | Link |
|---|---|---|---|
| CLCC-XEL-IRIN-OX | |||
| INCA-RECF0416 | |||
| VA-XIOX | |||
| EudraCT-2005-004567-38 |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of capecitabine conducted in two parts.
Cohorts of up to 6 patients receive escalating doses (up to 5 dosages) of capecitabine. The maximum tolerated dose (MTD) is defined as the dose at which 50% of patients experience toxicity during the first 2 courses of therapy.
Cohorts of up to 6 patients receive escalating doses (up to 7 dosages) of capecitabine. The MTD is defined as in part I.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irinotecan hydrochloride | Drug | |||
| oxaliplatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of capecitabine | ||
| Dose-limiting toxicities |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended phase II dose of capecitabine | ||
| Toxicity profile | ||
| Objective response |
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DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically confirmed metastatic carcinoma
Measurable, evaluable, or nonevaluable disease
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Severe concurrent infection or major organ failure, including any of the following:
Prior severe toxicity from fluorouracil
Intestinal obstruction or subobstruction
Malabsorption syndrome
Peripheral neuropathy
Uncontrolled epilepsy
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusions criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Ychou, MD, PhD | Institut du Cancer de Montpellier - Val d'Aurelle |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Recruiting | Montpellier | 34298 | France |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
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| Duration of response |
| Time to disease progression |
| Pharmacokinetic profile of capecitabine and irinotecan hydrochloride |
| D009930 |
| Organic Chemicals |