Calcitriol Plus Paclitaxel in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00009802|
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : December 19, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Calcitriol may increase the effectiveness of paclitaxel by making tumor cells more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining calcitriol with paclitaxel in treating patients who have advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Dietary Supplement: calcitriol Drug: paclitaxel||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Official Title:||A Phase I Trial Of Oral Calcitriol [1,25-(OH)2D3] And Paclitaxel In Advanced Solid Tumors|
|Study Start Date :||June 1998|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00009802
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213-3489|
|Study Chair:||Ramesh K. Ramanathan, MD||University of Pittsburgh|