Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer

• Status: Completed
• Trial end date: 2002-09-11
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in limiting weight loss in patients who are undergoing radiation therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss in patients who are undergoing radiation therapy for lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest Baptist Health; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Megestrol; Megestrol Acetate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed lung cancer

• Unresectable stage I-IIIB non-small cell lung cancer (NSCLC)

• Resected stage I-IIIB NSCLC

• Limited stage small cell lung cancer

• Planned radiotherapy with a total dose of at least 5,000 cGy in fraction sizes of no greater than 200 cGy each

• No distant metastases

• No significant ascites, pleural effusions, or edema that would inhibit oral food intake or invalidate weight determinations

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No uncontrolled hypertension

• No active thromboembolic disease

• No myocardial infarction within the past 3 months

• No prior congestive heart failure or thromboembolic events

Pulmonary:

• No prior pulmonary edema

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 3 years except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer

• No uncontrolled diabetes with glycosylated hemoglobin greater than 10%

• No Cushing's syndrome

• No dietary restrictions (e.g., salt, sugar, or lipid)

• No other serious medical or psychiatric illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Endocrine therapy

Endocrine therapy:

• At least 12 months since prior corticosteroids, estrogens, progestins, or other steroid hormone except as antiemetic prior to chemotherapy

• No concurrent corticosteroids, estrogens, progestins, or other steroid hormone except as antiemetic prior to chemotherapy

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy to lung

Surgery:

• See Disease Characteristics

• More than 14 days since prior surgery