Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
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.
Detailed description
OBJECTIVES: Primary * Determine the maximum tolerated dose and dose-limiting toxicities of capecitabine. Secondary * Determine the recommended phase II dose of capecitabine. * Define the toxicity profile. * Evaluate potential antitumor activity in terms of objective response, duration of response, and time to disease progression. * Evaluate the pharmacokinetic profile of capecitabine and irinotecan hydrochloride. OUTLINE: This is a dose-escalation study of capecitabine conducted in two parts. * Part I: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1 and oral capecitabine twice daily on days 1-7. Treatment repeats every 2 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. 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. * Part II: Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on day 1 and oral capecitabine on days 1-7. Treatment repeats every 2 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Cohorts of up to 6 patients receive escalating doses (up to 7 dosages) of capecitabine. The MTD is defined as in part I.
Interventions
DRUGirinotecan hydrochloride
DRUGoxaliplatin
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose of capecitabine | — |
| Dose-limiting toxicities | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile of capecitabine and irinotecan hydrochloride | — |
| Recommended phase II dose of capecitabine | — |
| Duration of response | — |
| Objective response | — |
| Toxicity profile | — |
| Time to disease progression | — |
Countries
France
Outcome results
None listed