Capecitabine, Irinotecan, and Oxaliplatin in Treating Patients With Metastatic Cancer

NCT ID: NCT00544063

Last Updated: 2009-12-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

irinotecan hydrochloride

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• 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

Exclusion Criteria

• Symptomatic brain metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

• 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:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Principal Investigators

Marc Ychou, MD, PhD

Role:

Institut du Cancer de Montpellier - Val d'Aurelle

Locations

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Marc Ychou, MD, PhD

Role: primary

Other Identifiers

CLCC-XEL-IRIN-OX

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0416

Identifier Type: -

Identifier Source: secondary_id

VA-XIOX

Identifier Type: -

Identifier Source: secondary_id

EudraCT-2005-004567-38

Identifier Type: -

Identifier Source: secondary_id

CDR0000564073

Identifier Type: -

Identifier Source: org_study_id