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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00544063
First received: October 13, 2007
Last updated: December 13, 2009
Last verified: July 2009
  Purpose

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 [ Designated as safety issue: Yes ]
  • Dose-limiting toxicities [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recommended phase II dose of capecitabine [ Designated as safety issue: Yes ]
  • Toxicity profile [ Designated as safety issue: Yes ]
  • Objective response [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Pharmacokinetic profile of capecitabine and irinotecan hydrochloride [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Centre Val d'Aurelle - Paul Lamarque
Investigators
Investigator: Marc Ychou, MD, PhD Centre Val d'Aurelle - Paul Lamarque
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00544063     History of Changes
Other Study ID Numbers: CDR0000564073, CLCC-XEL-IRIN-OX, INCA-RECF0416, VA-XIOX, EudraCT-2005-004567-38
Study First Received: October 13, 2007
Last Updated: December 13, 2009
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Capecitabine
Irinotecan
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 30, 2014