Epirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced, Metastatic, or Recurrent Solid Tumor

Phase 1

Completed

• Conditions: Esophageal Cancer; Extrahepatic Bile Duct Cancer; Gastric Cancer; Head and Neck Cancer; Liver Cancer; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00021047
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin, carboplatin, and capecitabine in treating patients who have unresectable locally advanced, metastatic, or recurrent solid tumor.

Detailed Description

OBJECTIVES:

* Determine the maximum tolerated dose and the recommended phase II dose of capecitabine administered with epirubicin and carboplatin in patients with unresectable locally advanced, metastatic, or recurrent solid tumors.

* Determine the toxic effects of this regimen in these patients.

* Determine the pharmacokinetics (PK) of capecitabine and correlate these PK parameters with clinical toxicity of this regimen in these patients.

* Correlate end-of-infusion levels of epirubicin and its metabolites with epirubicin dose and clinical toxicity of this regimen in these patients.

* Determine the possible correlation between polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity of this regimen in these patients.

* Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of capecitabine.

Patients receive epirubicin IV over 2 hours and carboplatin IV over 30 minutes on day 1 and oral capecitabine twice daily on days 2-5, 8-12, and 15-19. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 24 additional patients are treated at the recommended phase II dose.

PROJECTED ACCRUAL: A total of 3-45 patients (24 patients for phase II) will be accrued for this study within 2 years.

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2001-07-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Completion: 2004-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States

Center for Cancer Research; 🇺🇸 Bethesda, Maryland, United States

Naval Medical Center, Portsmouth; 🇺🇸 Portsmouth, Virginia, United States