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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: October 13, 2007
Last updated: December 13, 2009
Last verified: July 2009

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.

Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: irinotecan hydrochloride
Drug: oxaliplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Phase I Study Evaluating the Feasibility of Chemotherapy With Capecitabine, Irinotecan, and Oxaliplatin in Patients With Metastatic Carcinoma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose of capecitabine
  • Dose-limiting toxicities

Secondary Outcome Measures:
  • Recommended phase II dose of capecitabine
  • Toxicity profile
  • Objective response
  • Duration of response
  • Time to disease progression
  • Pharmacokinetic profile of capecitabine and irinotecan hydrochloride

Estimated Enrollment: 33
Study Start Date: October 2006
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:



  • Determine the maximum tolerated dose and dose-limiting toxicities of capecitabine.


  • 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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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


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


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00544063

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Marc Ychou, MD, PhD    33-4-6761-3066   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
OverallOfficial: Marc Ychou, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle
  More Information Identifier: NCT00544063     History of Changes
Other Study ID Numbers: CDR0000564073
Study First Received: October 13, 2007
Last Updated: December 13, 2009

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017