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
Recruitment status was Recruiting
Sponsor:
Centre Val d'Aurelle - Paul Lamarque
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
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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) |
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 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:
|
Oxaliplatin Irinotecan Capecitabine Camptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic |
Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on October 17, 2012
