Capecitabine, Irinotecan, and Oxaliplatin in Treating Patients With Metastatic Cancer - Full Text View

Sponsored by:	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00544063

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 I

MedlinePlus related topics: Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride Capecitabine Oxaliplatin

U.S. FDA Resources

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

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

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

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

Investigators

Investigator:

Marc Ychou, MD, PhD

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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 31, 2008
ClinicalTrials.gov Identifier:	NCT00544063
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Oxaliplatin
Capecitabine
Irinotecan

Neoplasm Metastasis
Camptothecin
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009