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Irinotecan and Carboplatin in Treating Patients With Metastatic or Recurrent Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387660
First Posted: October 13, 2006
Last Update Posted: May 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Pfizer
Information provided by (Responsible Party):
University of California, Davis
Results First Submitted: January 13, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: carboplatin
Drug: irinotecan

  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
The recruitment period was 6 years. Subjects were recruited at 4 large medical centers.

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
Arm A - Metastatic SCLC (no Previous Chemo) Extensive small cell lung cancer with no previous chemotherapy
Arm B - Relapsed SCLC (Previous Chemo) Relapsed small cell lung cancer with previous chemotherapy

Participant Flow:   Overall Study
    Arm A - Metastatic SCLC (no Previous Chemo)   Arm B - Relapsed SCLC (Previous Chemo)
STARTED   40   40 
COMPLETED   40   40 
NOT COMPLETED   0   0 



  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.
No text entered.

Reporting Groups
  Description
Arm A Metastatic small cell lung cancer with no previous chemotherapy
Arm B Relapsed small cell lung cancer with previous chemotherapy
Total Total of all reporting groups

Baseline Measures
   Arm A   Arm B   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   80 
Age 
[Units: Years]
Median (Full Range)
 67 
 (50 to 81) 
 65 
 (43 to 80) 
 65 
 (43 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18  45.0%      23  57.5%      41  51.2% 
Male      22  55.0%      17  42.5%      39  48.8% 
Region of Enrollment 
[Units: Participants]
     
United States   40   40   80 


  Outcome Measures
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1.  Primary:   Overall Response Rate   [ Time Frame: Up to 36 months ]

2.  Secondary:   Median Survival of Patients Treated With This Regimen   [ Time Frame: Up to 36 months ]

3.  Secondary:   Number of Participants With Toxicity   [ Time Frame: Up to 36 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Of the 80 patients, 72 were assessable.


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


Results Point of Contact:  
Name/Title: Analyst
Organization: University of California, Davis
phone: 916-734-8053
e-mail: nlogihara@ucdavis.edu


Publications of Results:

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00387660     History of Changes
Obsolete Identifiers: NCT00462800
Other Study ID Numbers: UCDCC-124
P30CA093373 ( U.S. NIH Grant/Contract )
PFIZER-Z1000752 ( Other Grant/Funding Number: Pfizer )
First Submitted: October 12, 2006
First Posted: October 13, 2006
Results First Submitted: January 13, 2017
Results First Posted: May 1, 2017
Last Update Posted: May 1, 2017