Capecitabine, Irinotecan, and Oxaliplatin in Treating Patients With Metastatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|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|
- Maximum tolerated dose of capecitabine
- Dose-limiting toxicities
- Recommended phase II dose of capecitabine
- Toxicity profile
- Objective response
- Duration of response
- Time to disease progression
- Pharmacokinetic profile of capecitabine and irinotecan hydrochloride
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
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle||Recruiting|
|Montpellier, France, 34298|
|Contact: Marc Ychou, MD, PhD 33-4-6761-3066 firstname.lastname@example.org|
|OverallOfficial:||Marc Ychou, MD, PhD||Institut du Cancer de Montpellier - Val d'Aurelle|