Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Biomarker/Laboratory analysis, Prevention	Active	40 to 79	NCI	RPCI-I-90206 I 90205, NCT00690924

Objectives

Primary

1. To establish the safety of calcitriol in patients at high risk of lung cancer.
2. To determine the dose-limiting toxicities of calcitriol in these patients.

Entry 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

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

Patient Characteristics:

• ECOG performance status 0-1
• Total granulocyte count > 1,500 x 10⁹cells/L
• Platelet count > 100,000 x 10⁹cells/L
• Creatinine clearance > 60 mL/min
• 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)

Expected Enrollment

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Alex Adjei, MD, PhD, Principal investigator		Ph: 716-845-4101; 800-685-6825 Email: alex.adjei@roswellpark.org

U.S.A.
New York
	Buffalo
	Roswell Park Cancer Institute
		Alex Adjei, MD, PhD	Ph:  716-845-4101
			Email: alex.adjei@roswellpark.org

Registry Information
Official Title		A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer
Trial Start Date		2008-07-17
Trial Completion Date		2010-12-19 (estimated)
Registered in ClinicalTrials.gov		NCT00690924
Date Submitted to PDQ		2008-05-16
Information Last Verified		2009-06-07
NCI Grant/Contract Number		CA112238, CA16056

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