• Survival time [ Designated as safety issue: No ]
  

OBJECTIVES:

• Compare the percentage of patients with extensive stage small cell lung cancer who live longer than 12 months after receiving treatment with carboplatin and etoposide with or without oblimersen.
• Compare the response rate of patients treated with these regimens.
• Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oblimersen IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8.
• Arm II: Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 1 hour on days 1-3.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 55 patients (41 for arm I and 14 for arm II) will be accrued for this study within 11 months.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC) for which combination modality therapy with chemotherapy and radiotherapy is not being considered

• No active CNS metastases

  • Patients with CNS metastases are eligible if they have completed a course of CNS radiotherapy, if clinically indicated

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count at least 1,500/mm3
• Platelet count at least 100,000/mm3

Hepatic

• Bilirubin normal
• AST no greater than 2.5 times upper limit of normal (ULN)
• PT and PTT no greater than 1.5 times ULN

Renal

• Creatinine no greater than 2 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular

• No cardiac disease that would preclude study

Other

• HIV negative
• No other concurrent medical conditions that would preclude study
• No uncontrolled infection
• No psychiatric illness that would preclude informed consent
• No uncontrolled diabetes mellitus

• No other concurrent active malignancy except nonmelanoma skin cancer

  • Patients are not considered to have a currently active malignancy if they have completed therapy and have less than a 30% risk of relapse
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• No prior chemotherapy for SCLC
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy

• See Disease Characteristics
• At least 1 week since prior radiotherapy and recovered
• Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) allowed
• No concurrent palliative radiotherapy

Surgery

• Not specified