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

Eastern Cooperative Oncology Group

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: gemcitabine hydrochloride; Drug: exisulind; Drug: carboplatin

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00041314

E-E1501

CDR0000069467

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the 18-month survival rate in patients with advanced non-small cell lung cancer treated with carboplatin, gemcitabine, and exisulind.
• Determine the feasibility and toxicity of this regimen in these patients.
• Determine the response rate, progression-free survival, and overall median survival of patients treated with this regimen.

OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Chemotherapy repeats every 21 days for up to 6 courses. Patients also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until disease progression or unacceptable toxicity occurs.

Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 6 months.

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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