Calcitriol, Ketoconazole, and Dexamethasone in Treating Patients With Metastatic or Unresectable Solid Tumors

NCT00238225 | Completed Phase 1

• 2 other identifiers: I 33204RPCI-I-33204
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of calcitriol

Secondary Outcomes (1)

• Pharmacokinetics of calcitriol and dexamethasone with or without ketoconazole

Interventions

calcitriol DIETARY_SUPPLEMENT

dexamethasone DRUG

ketoconazole DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Metastatic or unresectable disease * Standard curative or reliable palliative therapy is no longer effective OR does not exist * Brain metastases allowed provided they have been treated with surgery or radiotherapy AND are stable PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8 g/dL * Platelet count ≥ 75,000/mm\^3 Hepatic * AST/ALT ≤ 2.5 times upper limit of normal * Bilirubin normal * No unstable or uncompensated hepatic disease Renal * Creatinine ≤ 2 mg/dL * No unstable or uncompensated renal disease * No history of kidney, urethral, or bladder stones within the past 5 years Cardiovascular * Ejection fraction ≥ 30% * No symptomatic congestive heart failure * No significant arrhythmias * No myocardial infarction within the past 3 months * No unstable angina pectoris * No unstable or uncompensated cardiac disease * No other significant heart disease Pulmonary * No unstable or uncompensated respiratory disease Immunologic * No known severe hypersensitivity to ketoconazole or calcitriol or any of the excipients of these products * No history of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs * No ongoing or active infection Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception prior to, during, and for 3 months after completion of study treatment * Able to receive oral medication * No sperm donation during and for ≥ 3 months after completion of study treatment * No evidence of significant clinical disorder or laboratory finding that would preclude study participation * No other severe or uncontrolled systemic disease * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic growth factors, including filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * Any number of prior chemotherapy regimens allowed Endocrine therapy * No concurrent systemic glucocorticoid therapy \> physiologic replacement doses Radiotherapy * See Disease Characteristics * Any number of prior radiotherapy regimens allowed Surgery * See Disease Characteristics * Recovered from prior major surgery * Concurrent surgery allowed provided ≥ 7 days has passed since the last dose of ketoconazole (ketoconazole may be restarted after adequate wound healing) Other * Recovered from prior anticancer therapy * Alopecia allowed * More than 30 days since prior nonapproved or investigational agents * More than 7 days since prior and no concurrent thiazides * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent digoxin or calcium supplementation * No concurrent proton pump inhibitor or H2 blockers * No concurrent medications that would alter the levels of ketoconazole and/or calcitriol, including the following: * Phenytoin * Carbamazepine * Barbiturates (e.g., phenobarbital) * Rifampin * Hypericum perforatum (St. John's wort) * No concurrent drugs that would be significantly impaired in a clinically important way by ketoconazole * No other concurrent investigational or commercial agents or therapies for this malignancy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Interventions

Calcitriol; Dexamethasone; Ketoconazole

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids, Fluorinated; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Donald L. Trump, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 13, 2005
• Study Start: November 1, 2004
• Primary Completion: June 1, 2006
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

US (1)