NCT00052273

LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors

A Phase I Dose Escalation Study With Oral LY317615 in Combination With Capecitabine in Advanced Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining LY317615 with capecitabine may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining LY317615 with capecitabine in treating patients who have advanced solid tumors.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose and the recommended phase II dose of LY317615 and capecitabine in patients with advanced solid tumors. * Determine the safety profile of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. * Determine, preliminarily, the antitumor activity of this regimen in these patients. * Determine the effects of LY317615 on potential angiogenic surrogate markers in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral LY317615 daily on days 1-14 (course 1 only). Beginning with course 2, patients receive oral LY317615 daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LY317615 and 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, additional patients are treated at the recommended phase II dose. Patients are followed at 30 days after the last dose of study drug. PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study.

Conditions

• Adult
• Solid Tumor

Interventions

Type	Name	Description
DRUG	capecitabine
DRUG	enzastaurin hydrochloride

Timeline

• Start date: 2002-12-01
• Primary completion: 2004-11-01
• Completion: 2005-10-01
• First posted: 2003-01-27
• Last updated: 2020-08-03

Locations

1 site across 1 country: United States