Lung Cancer, Precancerous Condition, Tobacco Use Disorder
Conditions
Keywords
lung cancer, tobacco use disorder, squamous lung dysplasia
Brief 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.
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.
Interventions
Oral
Correlative Study
Correlative Study
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks | 3 months | Number of participants with Adverse Events, Grade II lasting more than two weeks or Grade III or higher, graded according to CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Calcitriol calcitriol: Oral
laboratory biomarker analysis: Correlative Study
pharmacological study: Correlative Study | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Calcitriol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 60.1 years STANDARD_DEVIATION 8.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 13 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks
Number of participants with Adverse Events, Grade II lasting more than two weeks or Grade III or higher, graded according to CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
Time frame: 3 months
Population: All treated and eligible patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Calcitriol | Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks | II | 1 participants |
| Calcitriol | Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks | III | 0 participants |
| Calcitriol | Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks | IV | 0 participants |
| Calcitriol | Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks | V | 0 participants |