Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00008086|
Recruitment Status : Completed
First Posted : September 4, 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 help solid tumor cells develop into normal cells. Combining calcitriol with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of calcitriol combined with carboplatin in treating patients who have advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Unspecified Adult Solid Tumor, Protocol Specific||Dietary Supplement: calcitriol Drug: carboplatin||Phase 1|
- Determine the maximum tolerated doses of calcitriol and carboplatin, when given in combination, in patients with advanced solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Determine the effect of calcitriol on the pharmacokinetics of carboplatin in these patients.
- Correlate the pharmacokinetics of carboplatin with the myelosuppression following this regimen in these patients.
- Determine the safety and efficacy of this regimen in patients with malignant glioma.
OUTLINE: This is a dose-escalation study. Patients are stratified according to disease (brain tumor vs other solid tumor) and accrued in parallel. Patients are assigned to one of two treatment groups.
- Group 1: Patients receive carboplatin IV over 20-30 minutes on day 1 and calcitriol subcutaneously (SC) or orally daily on days 2-4 for the first course only. For subsequent courses, patients receive calcitriol SC or orally daily on days 1-3 and carboplatin IV over 20-30 minutes on day 3.
- Group 2: Patients receive calcitriol SC or orally daily on days 1-3 and carboplatin IV over 20-30 minutes on day 3 for the first, third, and subsequent courses. For the second course only, patients receive carboplatin IV over 20-30 minutes on day 1 and calcitriol SC or orally daily on days 2-4.
In both groups, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Sequential dose escalation of calcitriol is followed by sequential dose escalation of carboplatin. Cohorts of 3-6 patients receive escalating doses of calcitriol and then carboplatin until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 18-50 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Trial of Subcutaneous And/Or Oral Calcitriol [(1,25-COH)2D3] and Carboplatin in Advanced Solid Tumors|
|Study Start Date :||January 1996|
|Primary Completion Date :||September 2004|
|Study Completion Date :||September 2004|
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): NCT00008086
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213-3489|
|Study Chair:||Ramesh K. Ramanathan, MD||University of Pittsburgh|