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

NCT00084708 | Completed Phase 1 DMC

• 2 other identifiers: CDR0000365546RPCI-RPC-0207
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

Interventions

calcitriol DIETARY_SUPPLEMENT

dexamethasone DRUG

gefitinib DRUG

Eligibility Criteria

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

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

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; Gefitinib

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; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Marwan Fakih, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: November 1, 2002
• Primary Completion: October 1, 2006
• Study Completion: May 1, 2007
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

US (1)