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Calcitriol and Gefitinib With or Without Dexamethasone in Treating Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00084708
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : January 13, 2014
Information provided by:
Roswell Park Cancer Institute

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 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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Dietary Supplement: calcitriol Drug: dexamethasone Drug: gefitinib Phase 1

Detailed Description:



  • 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 advanced solid tumors.


  • Determine the pharmacokinetics and pharmacodynamics of these regimens in these patients.
  • Determine any tumor responses in patients treated with these regimens.

OUTLINE: This is a dose-escalation study of calcitriol.

  • Stage 1: Patients receive calcitriol IV over 1 hour on days 1, 15, and 22 and oral gefitinib once daily on days 8-28 during course 1. For all subsequent courses, patients receive calcitriol IV over 1 hour on days 1, 8, 15, and 22 and oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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.

  • Stage 2: Patients receive calcitriol (beginning at 1 dose level below the MTD determined in stage 1) and gefitinib as in stage 1. Patients also receive oral dexamethasone once on the day before and twice on the day of each dose of calcitriol.

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: A Phase I Study of Intravenous (IV) Calcitriol in Combination With ZD1839 (IRESSA®) in Refractory Solid Tumors
Study Start Date : November 2002
Primary Completion Date : October 2006
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Maximum tolerated dose

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months


  • WBC ≥ 3,000/mm^3
  • Hemoglobin ≥ 8 g/dL
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • No unstable or uncompensated hepatic disease


  • 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


  • 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


  • No evidence of clinically active interstitial lung disease

    • Chronic, stable, asymptomatic, radiographic changes allowed
  • No other unstable or uncompensated respiratory disease


  • 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


Biologic therapy

  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)


  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • No other concurrent systemic glucocorticoid therapy


  • More than 4 weeks since prior radiotherapy and recovered


  • Recovered from prior major surgery
  • No prior nephrectomy


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084708

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Marwan Fakih, MD Roswell Park Cancer Institute

Responsible Party: Marwan Fakih, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00084708     History of Changes
Other Study ID Numbers: CDR0000365546
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014

Keywords provided by Roswell Park Cancer Institute:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents