DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer

Information source: Roswell Park Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer; Precancerous Condition; Tobacco Use Disorder

Intervention: calcitriol (Drug); laboratory biomarker analysis (Other); pharmacological study (Other)

Phase: Phase 1

Status: Recruiting

Sponsored by: Roswell Park Cancer Institute

Official(s) and/or principal investigator(s):
Alex A. Adjei, MD, PhD, Principal Investigator, Affiliation: Roswell Park Cancer Institute

Summary

RATIONALE: Calcitriol may prevent lung cancer in patients with metaplasia or dysplasia of the lungs. PURPOSE: This clinical trial is studying the side effects and best dose of calcitriol in preventing lung cancer in current smokers and former smokers at high risk of lung cancer.

Clinical Details

Official title: A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Grade III-IV toxicities or any grade II toxicities lasting more than 2 weeks

Detailed description: OBJECTIVES: Primary

- To establish the safety of calcitriol in patients at high risk of lung cancer.

- To determine the dose-limiting toxicities of calcitriol in these patients.

OUTLINE: Patients receive oral calcitriol on day 1. Courses repeat every 2 weeks for 3 months in absence of unacceptable toxicity. Patients undergo blood collection periodically for pharmacokinetic and molecular analysis. After completion of study therapy, patients are followed periodically.

Eligibility

Minimum age: 40 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Pathologically confirmed squamous metaplasia or squamous dysplasia of the lungs by

autofluorescence bronchoscopy within the past 5 years

- Must be a current or former smoker

- No evidence of concurrent disease with lung cancer or head and neck cancer

- History of treated lung cancer or head and neck cancer treated with curative

intent allowed, provided that there has been no evidence of disease for > 1 year PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Total granulocyte count > 1,500 x 10^9cells/L

- Platelet count > 100,000 x 10^9cells/L

- Calculated Creatinine clearance > 60 mL/min (using the Cockcroft-Gault formula)

- Calcium concentration 50-300 mg/24 hours

- Total bilirubin 0. 2-1. 3 mg%

- ALT/AST ≤ 2. 5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2. 5 times ULN

- Albumin ≥ 2. 5 g/dL

- Ionized serum calcium normal (1. 19-1. 29 mmol/L)

- Corrected serum calcium ≤ 10. 2 mg/dL

- Willing to attend all scheduled study visits, complete all study questionnaires, and

allow biological specimen collection, including a bronchoscopy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 1 month

after completion of study therapy

- No life-threatening medical conditions that would preclude bronchoscopy, including

but not limited to, any of the following:

- Acute cardiac failure

- Uncontrolled hypertension

- Uncontrolled diabetes mellitus

- Unstable coronary artery disease

- No severe metabolic disorders that would preclude calcitriol administration

- No history of any other malignancy within 3 years except for nonmelanoma skin cancer

or cervical carcinoma in situ

- No history or evidence of kidney stones

- No patients who are susceptible to calcium-related dysrhythmias

- No known hypersensitivity to calcitriol

- No known allergies to tree nuts (i. e., almonds)

PRIOR CONCURRENT THERAPY:

- At least 2 months since prior and no concurrent calcium supplements

- Concurrent multivitamin supplement allowed provided the amount of vitamin D in the

supplement is not in excess of the recommended daily dose

- No concurrent thiazides, phenobarbital, or digitalis

- No concurrent digoxin

- No concurrent bile acid binding drugs (i. e., cholestyramine, colestipol)

- No concurrent danazol or aluminum-based antacids

- No concurrent ketoconazole or other azole antifungals

Locations and Contacts

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States; Recruiting
AskRPCI, Phone: 877-275-7724, Email: AskRPCI@RoswellPark.org
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2008
Last updated: June 3, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017