Completed

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

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What is being tested

calcitriol

+ dexamethasone
+ gefitinib
Dietary Supplement
Drug
Who is being recruted

Unspecified Adult Solid Tumor, Protocol Specific

Over 18 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 2002

Summary

Principal SponsorRoswell Park Cancer Institute
Last updated: January 13, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2002Actual date on which the first participant was enrolled.

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. 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. 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.

Official TitleA Phase I Study of Intravenous (IV) Calcitriol in Combination With ZD1839 (IRESSA®) in Refractory Solid Tumors 
Principal SponsorRoswell Park Cancer Institute
Last updated: January 13, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
53 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Unspecified Adult Solid Tumor, Protocol Specific
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: 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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Roswell Park Cancer InstituteBuffalo, United StatesSee the location

CompletedOne Study Center