A Phase I Trial Of Oral Calcitriol [1,25-(OH)2D3] And Paclitaxel In Advanced Solid Tumors
- Determine the toxic effects and maximum tolerated dose of calcitriol when combined with
paclitaxel in patients with advanced solid tumors.
- Determine the effect of administration of calcitriol on the pharmacokinetics of
paclitaxel in these patients.
- Determine the effect of administration of paclitaxel on the pharmacokinetics of
calcitriol in these patients.
OUTLINE: This is a dose-escalation study of calcitriol.
During course 1, patients receive oral calcitriol daily on days 1-3 of weeks 1-6 and
paclitaxel IV over 1 hour on day 1 of week 1 and day 3 of weeks 2-6. During course 2 and
subsequent courses, patients receive oral calcitriol daily on days 1-3 and paclitaxel IV
over 1 hour on day 3 of weeks 1-6. Treatment continues every 8 weeks in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the highest dose giving an estimated
probability of dose-limiting toxicity of no more than 0.30.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Primary Purpose: Treatment
Ramesh K. Ramanathan, MD
University of Pittsburgh
United States: Federal Government
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|