OBJECTIVES:

• Determine the maximum tolerated dose of oblimersen when combined with standard dose carboplatin and etoposide in patients with previously untreated extensive stage small cell lung cancer.
• Determine the toxicity and feasibility of this regimen in these patients.
• Determine potential antitumor activity of this regimen as assessed by objective response in these patients.

OUTLINE: This is a multicenter, dose-escalation study of oblimersen (G3139).

Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of G3139 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 6-12 patients will be accrued for this study within 5 months.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed extensive stage small cell lung cancer

• No active CNS disease

  • CNS metastasis allowed provided patient completed 1 course of CNS radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2
• Karnofsky 60-100%

Life expectancy:

• More than 2 months

Hematopoietic:

• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

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

Renal:

• Creatinine normal OR
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior allergic reactions to compounds of similar chemical or biologic composition to study agents
• No other uncontrolled concurrent illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 1 week since prior CNS radiotherapy and recovered
• No prior radiotherapy to more than 25% of skeleton

Surgery:

• Not specified

Other:

• No other prior anticancer therapy
• No other concurrent investigational agents
• No other concurrent anticancer therapy
• No concurrent anticoagulation therapy
• No concurrent combination antiretroviral therapy for HIV-positive patients