Solid Tumor Clinical Trial
Official title:
A Phase I Dose Escalation Study With Oral LY317615 in Combination With Capecitabine in Advanced Cancer Patients
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.
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.
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