OBJECTIVES:

• Determine the progression-free survival of patients with extensive-stage small cell lung cancer treated with CCI-779.
• Determine the toxicity of this drug in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to brain metastases (yes vs no), prior induction chemotherapy regimen (platinum and etoposide vs platinum and irinotecan), and response to prior induction chemotherapy (complete or partial response vs stable disease). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive low-dose CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive high-dose CCI-779 as in arm I. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 2.7-3.2 years.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer

  • Extensive disease
  • Responsive or stable disease after prior induction chemotherapy comprising cisplatin or carboplatin AND etoposide or irinotecan
• No untreated, symptomatic brain metastases that require concurrent corticosteroids

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• Cholesterol less than 350 mg/dL
• Triglycerides less than 400 mg/dL

Renal:

• Creatinine no greater than 1.5 mg/dL

Other:

• No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No prior allergic reactions attributed to compounds of similar chemical or biological composition to CCI-779 or to any of the components of its formulation
• No allergy or contraindications to antihistamines
• Not immunocompromised
• No active or serious concurrent infection
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for at least 12 weeks after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biological response modifiers

Chemotherapy:

• See Disease Characteristics
• No less than 3 and no more than 6 prior courses of induction chemotherapy
• At least 4 and no more than 8 weeks since prior induction chemotherapy and recovered
• No more than 32 weeks since first dose of induction chemotherapy for metastatic disease

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• At least 4 weeks since prior radiotherapy
• No prior radiotherapy to target lesions

Surgery:

• Not specified

Other:

• At least 3 weeks since prior immunosuppressive therapy
• No concurrent anticonvulsant therapy