Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2007-06-15
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind in treating patients who have advanced non-small cell lung cancer.

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

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Gemcitabine; Sulindac sulfone

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer (NSCLC)

• Unresectable stage IIIB (e.g., pleural effusion) not suitable for combined modality therapy OR

• Stage IV

• Prior brain metastases are allowed provided the following are true:

• Patient completed radiotherapy and/or surgery at least 3 weeks prior to study

• Objective evidence of resolution or significant improvement of brain lesions exists on follow-up CT scan or MRI

• Patient is neurologically improved or stable

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3

• WBC at least 3,000/mm^3

• Hemoglobin at least 9 g/L

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.25 mg/dL

• SGOT no greater than 1.5 times upper limit of normal

Renal:

• Creatinine no greater than 2.0 mg/dL OR

• Creatinine clearance at least 50 mL/min

Cardiovascular:

• No prior uncontrolled cardiovascular disease

• No hospitalization for acute myocardial infarction, arrhythmia, or congestive heart failure within the past 3 months

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective nonhormonal contraception

• No serious active infection

• No dementia or active psychoses

• No other prior malignancy except nonmetastatic nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer curatively treated with surgery or small-field radiotherapy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 1 month since prior investigational agents

• More than 7 days since prior aspirin, sulindac, cyclo-oxygenase-2 (COX-2) inhibitors, or nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen)

• No concurrent sulindac or COX-2 inhibitors