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

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ClinicalTrials.gov Identifier: NCT00544063
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 16, 2007
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
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
Study Start Date : October 2006
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Maximum tolerated dose of capecitabine
  2. Dose-limiting toxicities

Secondary Outcome Measures :
  1. Recommended phase II dose of capecitabine
  2. Toxicity profile
  3. Objective response
  4. Duration of response
  5. Time to disease progression
  6. Pharmacokinetic profile of capecitabine and irinotecan hydrochloride


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544063


Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Marc Ychou, MD, PhD    33-4-6761-3066    mychou@valdorel.fnclcc.fr   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
OverallOfficial: Marc Ychou, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle

ClinicalTrials.gov Identifier: NCT00544063     History of Changes
Other Study ID Numbers: CDR0000564073
CLCC-XEL-IRIN-OX
INCA-RECF0416
VA-XIOX
EudraCT-2005-004567-38
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: July 2009

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

Additional relevant MeSH terms:
Capecitabine
Oxaliplatin
Irinotecan
Camptothecin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors