Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed small cell lung cancer (SCLC)

  • Recurrent extensive stage disease
  • No mixed histology

• Measurable disease

  • At least 1 bidimensionally measurable, non-central nervous system (CNS), indicator lesion confirmed by CT scan or MRI

• Sensitive disease

  • Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90 days after initiation of first-line therapy)
• Eligible for high-dose chemotherapy
• No symptomatic brain metastases affecting performance status

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

• At least 2 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL
• Hematocrit > 35% (without transfusion)

Hepatic

• Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) ≤ 2 times normal*
• Alkaline phosphatase ≤ 2 times normal*
• Bilirubin ≤ 2.0 mg/dL
• Albumin > 2.5 g/dL
• Hepatitis B surface antigen negative
• No significant hepatic disease Note: *≤ 5 times upper limit of normal if liver metastases are present

Renal

• Creatinine clearance ≥ 40 mL/min

Cardiovascular

• No history of cardiac arrhythmias
• No congestive heart failure
• No ischemic heart disease
• No stroke or other embolic disease requiring daily treatment that would preclude study participation

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• HIV negative
• No known seizure disorder
• No active infection requiring systemic therapy within the past 2 weeks
• No known hypersensitivity to topotecan hydrochloride
• No medical or psychiatric condition that would preclude study participation
• No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy
• No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC
• No prior topotecan hydrochloride

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 2 months since prior investigational agent
• No other concurrent investigational agent