The 'MADe IT' Clinical Trial: Molecular Analyses Directed Individualized Therapy for Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Aventis Pharmaceuticals
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00215930
First received: September 15, 2005
Last updated: December 13, 2013
Last verified: March 2011
Results First Received: October 8, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Interventions: Drug: Vinorelbine
Drug: Docetaxel
Drug: Gemcitabine
Drug: Carboplatin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Assignments: High ERCC1 expression and High RRM1 Expression - vinorelbine plus docetaxel (DV); High ERCC1 expression but NOT High RRM1 expression - docetaxel plus gemcitabine (GD); High ERCC1 expression, but HAVE High RRM1 - carboplatin plus docetaxel (DC); High ERCC1 expression and do NOT have High RRM1 - carboplatin plus gemcitabine (GC)

Reporting Groups
  Description
Double Agent Chemotherapy Molecular Analysis-Directed Chemotherapy Assignment based on gene expression of Ribonucleotide reductase subunit 1(ERCC1) and Excision repair cross-complementing group 1 gene (RRM1). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days. DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days. DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days. GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days.

Participant Flow:   Overall Study
    Double Agent Chemotherapy  
STARTED     53  
COMPLETED     53  
NOT COMPLETED     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.
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Reporting Groups
  Description
Double Agent Chemotherapy Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.

Baseline Measures
    Double Agent Chemotherapy  
Number of Participants  
[units: participants]
  53  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     37  
>=65 years     16  
Age, Customized  
[units: years]
Median ( Full Range )
  63  
  ( 38 to 78 )  
Gender  
[units: participants]
 
Female     22  
Male     31  
Region of Enrollment  
[units: participants]
 
United States     53  



  Outcome Measures
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1.  Primary:   Best Disease Response After a Maximum of Six Cycles.   [ Time Frame: 24 Months ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: 24 Months ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: 24 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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerald Bepler, M.D., via Moffitt Cancer Center
Organization: Karmanos Cancer Institute (formerly at Moffitt Cancer Center)
phone: 813-745-4398
e-mail: beplerg@karmanos.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00215930     History of Changes
Other Study ID Numbers: MCC-13208
Study First Received: September 15, 2005
Results First Received: October 8, 2010
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration