NCT00084708CompletedPhase 1
A Phase I Study of Intravenous (IV) Calcitriol in Combination With ZD1839 (IRESSA®) in Refractory Solid Tumors
Roswell Park Cancer Institute1 site in 1 country53 target enrollmentStarted: November 1, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose
Study Overview
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.
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 advanced solid tumors.
Secondary
- Determine the pharmacokinetics and pharmacodynamics of these regimens in these patients.
- Determine any tumor responses in patients treated with these regimens.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •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
- •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
- •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
- •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
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- +21 more not shown
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maximum tolerated dose
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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