Rebeccamycin Analog as Second-Line Therapy in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer That Relapsed After Previous First-Line Chemotherapy
Extensive Stage Small Cell Lung Cancer, Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: 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 Brain metastasis allowed provided the following criteria are met: Stable brain disease Not receiving irradiation No steroid requirement to control symptoms Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% At least 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9.0 g/dL AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement is present) Bilirubin ≤ 1.5 mg/dL Creatinine < 2.0 mg/dL Creatinine clearance ≥ 60 mL/min No New York Heart Association class III or IV heart disease No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia 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 See Disease Characteristics See Disease Characteristics See Disease Characteristics Prior radiotherapy allowed No other concurrent investigational agents No other concurrent therapies for SCLC No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Case Western Reserve University
Arms of the Study
Arm 1
Experimental
Treatment (becatecarin)
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.