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Status:

COMPLETED

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

Lead Sponsor:

Roswell Park Cancer Institute

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 cel...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose of calcitriol when administered with ketoconazole and dexamethasone in patients with metastatic or unresectable solid tumors. Secondary *...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    15 Patients enrolled

    Trial Details

    Trial ID

    NCT00238225

    Start Date

    November 1 2004

    Last Update

    January 31 2013

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Roswell Park Cancer Institute

    Buffalo, New York, United States, 14263-0001