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

Phase 2

Terminated

Conditions: Extensive Stage Small Cell Lung Cancer
Limited Stage Small Cell Lung Cancer
Recurrent Small Cell Lung Cancer

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 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.

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 rebeccamycin analogue as second-line therapy.

II. Determine the duration of remission and survival of patients treated with this drug.

III. 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.

Recruitment & Eligibility

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 Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Treatment (becatecarin)	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate Estimated as the Proportion of Responders	Up to 4 years	Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. An exact binomial 95% confidence interval will be calculated for this proportion.
Progression Free Survival	Up to 4 years	Median time of patients without Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Duration of remission will be analyzed using Kaplan-Meier curves.
Overall Survival	Up to 4 years	Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	6 months	Percentage of patients that are progression free at 6 months.
Overall Survival	1 year	Percentage of patients alive at 1 year