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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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
becatecarin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Treatment (becatecarin)

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective Response Rate Estimated as the Proportion of Responders
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
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
Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves.

Secondary Outcome Measures

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

Full Information

First Posted
June 10, 2004
Last Updated
May 7, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00084487
Brief Title
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
Official Title
Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive Stage Small Cell Lung Cancer, Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (becatecarin)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
becatecarin
Other Intervention Name(s)
BMS-181176, rebeccamycin analogue, rebeccamycin analogue, tartrate salt, XL119
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Objective Response Rate Estimated as the Proportion of Responders
Description
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.
Time Frame
Up to 4 years
Title
Progression Free Survival
Description
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.
Time Frame
Up to 4 years
Title
Overall Survival
Description
Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
Percentage of patients that are progression free at 6 months.
Time Frame
6 months
Title
Overall Survival
Description
Percentage of patients alive at 1 year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afshin Dowlati
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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