Phase III of RRM1 & ERCC1 Directed Customized Chemotherapy for the Treatment of Patients With NSCLC

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00499109
First received: July 10, 2007
Last updated: June 25, 2014
Last verified: June 2014
Results First Received: September 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: Docetaxel
Drug: Vinorelbine
Drug: Carboplatin
Drug: Gemcitabine

  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
Participants were registered onto the trial between May 8, 2007 and December 23, 2010. Study sites included Moffitt Cancer Center and 8 other institutions with locations in the United States, Puerto Rico and Germany.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
E. Dual Agent Chemotherapy

Experimental Arm E.

Patients received treatment according to gene expression strata with four doublet regimens.

Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.

Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.

High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.

High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group.

C. Standard of Care Control Arm

Control Arm C: Gemcitabine and Carboplatin (GCb).

All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed.


Participant Flow:   Overall Study
    E. Dual Agent Chemotherapy     C. Standard of Care Control Arm  
STARTED     183     92  
COMPLETED     165     85  
NOT COMPLETED     18     7  



  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.
All Participants

Reporting Groups
  Description
E. Dual Agent Chemotherapy

Experimental Arm E.

Patients received treatment according to gene expression strata with four doublet regimens.

Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.

Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.

High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.

High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group.

C. Standard of Care Control Arm

Control Arm C: Gemcitabine and Carboplatin (GCb).

All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed.

Total Total of all reporting groups

Baseline Measures
    E. Dual Agent Chemotherapy     C. Standard of Care Control Arm     Total  
Number of Participants  
[units: participants]
  183     92     275  
Age  
[units: years]
Mean ( Full Range )
  64.1  
  ( 42.1 to 85 )  
  62.3  
  ( 39.6 to 82.5 )  
  63.5  
  ( 39.6 to 85 )  
Gender  
[units: participants]
     
Female     93     49     142  
Male     90     43     133  
Region of Enrollment  
[units: participants]
     
United States     156     75     231  
Puerto Rico     3     1     4  
Germany     24     16     40  



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: 6 months ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: 12 months ]

3.  Secondary:   Response Rate (RR)   [ Time Frame: 6 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
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  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: Charles C. Williams, M.D., Study Chair
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-7282
e-mail: charles.williams@moffitt.org


No publications provided by H. Lee Moffitt Cancer Center and Research Institute

Publications automatically indexed to this study:

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00499109     History of Changes
Other Study ID Numbers: MCC-15005, 105372, IST 12223, CA129343
Study First Received: July 10, 2007
Results First Received: September 12, 2013
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board