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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

becatecarin

Intervention Type DRUG

Given IV

Interventions

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becatecarin

Given IV

Intervention Type DRUG

Other Intervention Names

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BMS-181176 rebeccamycin analogue rebeccamycin analogue, tartrate salt XL119

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No