NCT00003707

Combination Chemotherapy in Treating Patients With Advanced Cancer

A Phase I, Maximum Tolerated Dose (MTD) Trial to Determine the Safety and Pharmacokinetics of Chronic Oral Administration of Farnesyl Transferase Inhibitor R115777 in Combination With Gemcitabine in Subjects With Advanced Incurable Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining R115777 with gemcitabine in treating patients with advanced cancer.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose and dose limiting toxicities of tipifarnib in combination with gemcitabine in patients with advanced cancer. * Investigate potential pharmacokinetic interactions between tipifarnib and gemcitabine in these patients. * Determine the efficacy of this regimen in patients with measurable or evaluable disease. * Evaluate the quality of life of these patients. OUTLINE: This is a dose-escalation study of tipifarnib. Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral tipifarnib every 12 hours beginning on day 2. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which fewer than one third of the patients experience dose limiting toxicity. Quality of life is assessed before treatment, on day 22 of each course, and at the end of treatment. PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride
DRUG	tipifarnib

Timeline

• Start date: 1998-10-01
• Primary completion: 2002-11-01
• Completion: 2002-11-01
• First posted: 2003-07-15
• Last updated: 2012-06-28

Locations

1 site across 1 country: United States