Phase I Study Evaluating the Feasibility of Chemotherapy With Capecitabine, Irinotecan, and Oxaliplatin in Patients With Metastatic Carcinoma
18 Years
75 Years
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Study Evaluating the Feasibility of Chemotherapy With Capecitabine, Irinotecan, and Oxaliplatin in Patients With Metastatic Carcinoma
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.
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of capecitabine
Safety Issue:
Yes
Principal Investigator
Marc Ychou, MD, PhD
Investigator Affiliation:
Centre Val d'Aurelle - Paul Lamarque
Authority:
Unspecified
Study ID:
CDR0000564073
NCT ID:
NCT00544063
Start Date:
October 2006
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
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