Text Size

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:
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00215930
First received: September 15, 2005
Last updated: March 11, 2011
Last verified: March 2011
History of Changes
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
  Show All Outcome Measures

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

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

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: 24 Months ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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.


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: Gerald Bepler, M.D.
Organization: Karmanos Cancer Institute (formerly at Moffitt Cancer Center)
phone: 313-576-8665
e-mail: beplerg@karmanos.org


No publications provided


Responsible Party: Gerold Bepler, M.D., Ph.D., Karmanos Cancer Center
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: March 11, 2011
Health Authority: United States: Food and Drug Administration