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Status:

COMPLETED

Calcitriol and Gefitinib With or Without Dexamethasone in Treating Patients With Advanced 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: 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 ef...

Detailed Description

OBJECTIVES: Primary * 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...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed advanced solid tumor
  • Metastatic or unresectable disease
  • Standard curative or palliative measures do not exist or are no longer effective
  • No known brain metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2 OR
  • Karnofsky 60-100%
  • Life expectancy
  • More than 3 months
  • Hematopoietic
  • WBC ≥ 3,000/mm\^3
  • Hemoglobin ≥ 8 g/dL
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • No unstable or uncompensated hepatic disease
  • Renal
  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min
  • No prior hypercalcemia
  • No kidney, ureteral, or bladder stones within the past 10 years
  • No unstable or uncompensated renal disease
  • Cardiovascular
  • Ejection fraction ≥ 30%
  • No heart failure or significant heart disease
  • No significant arrhythmias
  • No myocardial infarction within the past 3 months
  • No unstable angina pectoris
  • No symptomatic congestive heart failure
  • No other unstable or uncompensated cardiac disease
  • Pulmonary
  • No evidence of clinically active interstitial lung disease
  • Chronic, stable, asymptomatic, radiographic changes allowed
  • No other unstable or uncompensated respiratory disease
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after study treatment
  • Able to receive oral medication
  • Willing to have serial skin biopsies
  • No prior allergic reaction to compounds of similar chemical or biological composition to study drugs or other agents used in this study
  • No ongoing or active infection
  • No known severe hypersensitivity to gefitinib or any of its excipients
  • No psychiatric illness or social situation that would preclude study compliance
  • No other severe or uncontrolled systemic disease or concurrent illness that would preclude study participation
  • No other significant clinical disorder or laboratory finding that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Chemotherapy
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Endocrine therapy
  • No other concurrent systemic glucocorticoid therapy
  • Radiotherapy
  • More than 4 weeks since prior radiotherapy and recovered
  • Surgery
  • Recovered from prior major surgery
  • No prior nephrectomy
  • Other
  • Recovered from all prior anticancer therapy
  • More than 30 days since prior non-approved or investigational drugs
  • More than 7 days since prior thiazides
  • No concurrent administration of any of the following:
  • Combination antiretroviral therapy for HIV-positive patients
  • Phenytoin
  • Carbamazepine
  • Barbiturates
  • Rifampin
  • Phenobarbital
  • Hypericum perforatum (St. John's wort)
  • Calcium supplements
  • Thiazides
  • Digoxin
  • No other concurrent investigational or commercial anticancer agents or therapies

Exclusion

    Key Trial Info

    Start Date :

    November 1 2002

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2007

    Estimated Enrollment :

    53 Patients enrolled

    Trial Details

    Trial ID

    NCT00084708

    Start Date

    November 1 2002

    End Date

    May 1 2007

    Last Update

    January 13 2014

    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