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

• Status: Terminated
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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 analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that has relapsed after previous first-line chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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