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

This study has been terminated.
(Drug availability)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00084487
First received: June 10, 2004
Last updated: November 12, 2013
Last verified: November 2013
Results First Received: November 12, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Extensive Stage Small Cell Lung Cancer
Limited Stage Small Cell Lung Cancer
Recurrent Small Cell Lung Cancer
Intervention: Drug: rebeccamycin analogue

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited for Cleveland area medical hospitals between November 2004 and November 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Rebeccamycin Analogue)

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.

becatecarin : Given IV


Participant Flow:   Overall Study
    Treatment (Rebeccamycin Analogue)  
STARTED     21  
COMPLETED     20  
NOT COMPLETED     1  
Death                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One patient died prior to start of treatment and is not included on any data analysis.

Reporting Groups
  Description
Treatment (Rebeccamycin Analogue)

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.

becatecarin : Given IV


Baseline Measures
    Treatment (Rebeccamycin Analogue)  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 45 to 72 )  
Gender  
[units: participants]
 
Female     10  
Male     10  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     16  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     20  
ECOG Performance Status [1]
[units: participants]
 
0     5  
1     10  
2     5  
Prior Therapy [2]
[units: participants]
 
Chemotherapy     20  
Radiation     8  
[1] Based on a scale of 0-4 with 0=100 Asymptomatic; 1=80-90 Symptomatic, fully ambulatory; 2=60-70 Symptomatic, in bed less than 50% of the day; 3=40-50 Symptomatic, in bed more than 50% of the day, but not bedridden; 4=20-30 Bedridden
[2] Number of patients exceeds number on study as some patients had both chemo and radiation.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate Estimated as the Proportion of Responders   [ Time Frame: Up to 4 years ]

2.  Primary:   Progression Free Survival   [ Time Frame: Up to 4 years ]

3.  Primary:   Overall Survival   [ Time Frame: Up to 4 years ]

4.  Secondary:   Progression Free Survival   [ Time Frame: 6 months ]

5.  Secondary:   Overall Survival   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Afshin Dowlati MD
Organization: Case Comprehensive Cancer Center
phone: 216-844-1228
e-mail: afshin.dowlati@uhhospitals.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00084487     History of Changes
Other Study ID Numbers: NCI-2012-02587, NCI-2012-02587, NCI-1990, CASE-1503, CDR0000365315, CASE-CWRU-1503, 1990, U01CA062502
Study First Received: June 10, 2004
Results First Received: November 12, 2013
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration