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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084708 |
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 | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: calcitriol Drug: dexamethasone Drug: gefitinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Intravenous (IV) Calcitriol in Combination With ZD1839 (IRESSA®) in Refractory Solid Tumors |
Estimated Enrollment: | 36 |
Study Start Date: | November 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of calcitriol.
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced solid tumor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No evidence of clinically active interstitial lung disease
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent administration of any of the following:
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Principal Investigator: | Marwan Fakih, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000365546, RPCI-RPC-0207, ZENECA-1839US/0295 |
Study First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00084708 |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Dexamethasone Calcium, Dietary Gefitinib Dexamethasone acetate Calcitriol |
Anti-Inflammatory 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 Protein Kinase Inhibitors Membrane Transport Modulators Therapeutic Uses Vitamins |
Vasoconstrictor Agents Micronutrients Antineoplastic Agents, Hormonal Growth Substances Gastrointestinal Agents Enzyme Inhibitors Cardiovascular Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |