Calcitriol and Gefitinib With or Without Dexamethasone in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00084708|
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : January 13, 2014
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Calcitriol may help tumor cells develop into normal cells. Dexamethasone may increase the effectiveness and decrease the side effects of gefitinib and calcitriol.
PURPOSE: This phase I trial is studying the side effects and best dose of calcitriol when given together with gefitinib or when given together with gefitinib and dexamethasone in treating patients with advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Dietary Supplement: calcitriol Drug: dexamethasone Drug: gefitinib||Phase 1|
- Determine the maximum tolerated dose (MTD), toxic effects, and tolerability of calcitriol alone and in combination with gefitinib with or without dexamethasone in patients with advanced solid tumors.
- Determine the pharmacokinetics and pharmacodynamics of these regimens in these patients.
- Determine any tumor responses in patients treated with these regimens.
OUTLINE: This is a dose-escalation study of calcitriol.
- Stage 1: Patients receive calcitriol IV over 1 hour on days 1, 15, and 22 and oral gefitinib once daily on days 8-28 during course 1. For all subsequent courses, patients receive calcitriol IV over 1 hour on days 1, 8, 15, and 22 and oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of calcitriol with a fixed dose of gefitinib 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.
- Stage 2: Patients receive calcitriol (beginning at 1 dose level below the MTD determined in stage 1) and gefitinib as in stage 1. Patients also receive oral dexamethasone once on the day before and twice on the day of each dose of calcitriol.
Cohorts 3-6 patients receive escalating doses of calcitriol with fixed doses of gefitinib and dexamethasone until the 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.
PROJECTED ACCRUAL: A total of 21-36 patients will be accrued for this study within 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Phase I Study of Intravenous (IV) Calcitriol in Combination With ZD1839 (IRESSA®) in Refractory Solid Tumors|
|Study Start Date :||November 2002|
|Primary Completion Date :||October 2006|
|Study Completion Date :||May 2007|
- Maximum tolerated dose
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): NCT00084708
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Marwan Fakih, MD||Roswell Park Cancer Institute|