Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Roswell Park Cancer Institute |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00238225 |
RATIONALE: Calcitriol may cause solid tumor cells to look more like normal cells, and to grow and spread more slowly. Ketoconazole and dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and dexamethasone may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of calcitriol when given together with ketoconazole and dexamethasone in treating patients with metastatic or unresectable solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Dietary Supplement: calcitriol Drug: dexamethasone Drug: ketoconazole |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Oral Calcitriol in Combination With Ketoconazole in Refractory Advanced Malignancies |
Estimated Enrollment: | 40 |
Study Start Date: | November 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of calcitriol.
Patients receive oral dexamethasone twice daily beginning on day 0 and oral ketoconazole 3 times daily beginning on day 4. Patients also receive oral calcitriol once daily on days 1-3 of each week. Treatment continues 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 dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed for up to 30 days.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
Radiotherapy
Surgery
Other
Recovered from prior anticancer therapy
No concurrent medications that would alter the levels of ketoconazole and/or calcitriol, including the following:
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Principal Investigator: | Donald L. Trump, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000441211, RPCI-I-33204 |
Study First Received: | October 12, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00238225 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Trace Elements Bone Density Conservation Agents Cardiovascular Agents Ketoconazole |
Hormones Glucocorticoids Calcitriol Calcium, Dietary Antifungal Agents Vitamins Vasoconstrictor Agents Micronutrients Peripheral Nervous System Agents Dexamethasone acetate |
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Calcium Channel Agonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Bone Density Conservation Agents Hormones Calcitriol Membrane Transport Modulators Antifungal Agents Vitamins |
Therapeutic Uses Vasoconstrictor Agents Micronutrients Dexamethasone acetate Antineoplastic Agents, Hormonal Growth Substances Gastrointestinal Agents Cardiovascular Agents Ketoconazole Glucocorticoids Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |