• Disease response measured every 6 weeks [ Designated as safety issue: No ]
  

• Disease response measured every 6 weeks‡ [ Designated as safety issue: No ]
  
• Survival measured every 6 weeks [ Designated as safety issue: No ]
  
• Toxicity as measured by CTC criteria weekly during treatment [ Designated as safety issue: Yes ]
  

OBJECTIVES:

• Determine the objective response rate in patients with limited or extensive stage small cell lung cancer that relapsed after prior first-line chemotherapy when treated with rebeccamycin analogue as second-line therapy.
• Determine the duration of remission and survival of patients treated with this drug.
• Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed annually.

PROJECTED ACCRUAL: A total of 20-39 patients will be accrued for this study within 15 months.

DISEASE CHARACTERISTICS:

• Diagnosis of small cell lung cancer (SCLC)

  • Limited or extensive stage
• At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• Sensitive* relapsed disease after only 1 prior chemotherapy regimen NOTE: *Disease progression ≥ 60 days after completing first-line therapy

• Brain metastasis allowed provided the following criteria are met:

  • Stable brain disease
  • Not receiving irradiation
  • No steroid requirement to control symptoms

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL

Hepatic

• AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement is present)
• Bilirubin ≤ 1.5 mg/dL

Renal

• Creatinine < 2.0 mg/dL OR
• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No New York Heart Association class III or IV heart disease
• 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 active or ongoing infection
• No other concurrent uncontrolled illness
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics
• Prior radiotherapy allowed

Surgery

• Not specified

Other

• No other concurrent investigational agents
• No other concurrent therapies for SCLC
• No concurrent combination antiretroviral therapy for HIV-positive patients