Status:
TERMINATED
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
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Extensive Stage Small Cell Lung Cancer
Limited Stage Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well rebeccamycin ana...
Detailed Description
OBJECTIVES: I. 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 rebeccamyci...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00084487
Start Date
April 1 2004
End Date
April 1 2008
Last Update
May 23 2014
Active Locations (1)
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1
Case Western Reserve University
Cleveland, Ohio, United States, 44106