Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may make the tumor cells more sensitive to radiation therapy.

PURPOSE: Phase I/II trial to study the effectiveness of combining celecoxib with radiation therapy in treating patients who have locally advanced non-small cell lung cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib; Cyclooxygenase 2 Inhibitors

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer

• Inoperable stage IIB OR

• Unresectable stage IIIA or IIIB

• No evidence of hematogenous metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 2 AND more than 5% weight loss over the past 3 months OR

• Zubrod 0-1 AND less than 5% weight loss over the past 3 months and refuses chemotherapy or are medically unable to tolerate combined modality therapy

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 2 times upper limit of normal

• International Normalized Ratio (INR) no greater than 3.0 if taking warfarin

Renal

• Creatinine clearance at least 50 mL/min

Other

• No active gastrointestinal ulcers or bleeding within the past 3 months

• No other malignancy within the past 3 years except nonmelanoma skin cancer

• No known hypersensitivity to celecoxib

• No prior allergic-type reactions to sulfonamides

• No prior asthma, urticaria, or allergic-type reactions to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior neoadjuvant chemotherapy

• No concurrent chemotherapy

Endocrine therapy

• No concurrent corticosteroids

Radiotherapy

• No prior thoracic radiotherapy

Surgery

• No prior complete or subtotal tumor resection

Other

• No concurrent NSAIDs, lithium, furosemide, or angiotensin-converting enzyme inhibitors

• Concurrent aspirin (325 mg/day) for cardioprotection allowed