Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function

Phase 1

Completed

• Conditions: Ovarian Cancer; Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific; Head and Neck Cancer; Breast Cancer

• Registration Number: NCT00002901
• Lead Sponsor: City of Hope Medical Center

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of docetaxel in treating patients with advanced solid tumors that have not responded to standard therapy or for which there is no effective therapy.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel in patients with advanced solid tumors and varying degrees of liver dysfunction. II. Determine the effects of liver dysfunction in these patients on the plasma pharmacokinetics and pharmacodynamics of this therapy. III. Determine the utility of indocyanine green clearance and lidocaine metabolism as indicators of hepatic elimination of docetaxel in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild vs moderate vs severe). Patients receive docetaxel IV over 1 hour. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR. Within each abnormal liver function stratum, cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Within each abnormal liver function stratum, more than 6 patients are treated at the MTD, if possible. Patients in the normal liver function stratum are included as control patients and are followed for toxicity, but do not undergo dose escalation. Patients are followed for survival.

PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-18 months.

Study Timeline

• Study Start: 1996-12
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-03-11
• Study First Posted: 2004-03-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-11
• Last Update Posted: 2010-01-13

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)

Cancer Center and Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States

USC/Norris Comprehensive Cancer Center and Hospital; 🇺🇸 Los Angeles, California, United States

University of California Davis Cancer Center; 🇺🇸 Sacramento, California, United States