Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This study has been terminated.
(Incidence of GI Perforation)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00378573
First received: September 19, 2006
Last updated: January 21, 2010
Last verified: January 2010
Results First Received: September 17, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Interventions: Drug: docetaxel
Drug: gemcitabine
Drug: bevacizumab

  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
No text entered.

Reporting Groups
  Description
Docetaxel, Gemcitabine and Bevacizumab Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.

Participant Flow for 2 periods

Period 1:   Treatment Period
    Docetaxel, Gemcitabine and Bevacizumab  
STARTED     17  
COMPLETED     0 [1]
NOT COMPLETED     17  
Adverse Event                 9  
Physician Decision                 1  
Withdrawal by Subject                 2  
Disease Progression                 4  
Sponsor decision to close study                 1  
[1] Patients who did not complete treatment moved directly to the follow-up phase of the study.

Period 2:   Follow-up
    Docetaxel, Gemcitabine and Bevacizumab  
STARTED     17  
COMPLETED     3  
NOT COMPLETED     14  
Death                 12  
Lost to Follow-up                 1  
Withdrawal by Subject                 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.
No text entered.

Reporting Groups
  Description
Docetaxel, Gemcitabine and Bevacizumab Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.

Baseline Measures
    Docetaxel, Gemcitabine and Bevacizumab  
Number of Participants  
[units: participants]
  17  
Age  
[units: Participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation
  64.1  ± 11.74  
Gender  
[units: Participants]
 
Female     11  
Male     6  
Region of Enrollment  
[units: Participants]
 
USA     17  
Disease Stage at 1st diagnosis  
[units: Participants]
 
IA     0  
IB     0  
IIA     0  
IIB     1  
IIIA     0  
IIIB     2  
IV     14  
Eastern Cooperative Oncology Group (ECOG) Performance Status  
[units: Participants]
 
0 - Fully Active     7  
1 - Ambulatory, Restricted Activity     8  
2 - Ambulatory, No Work Activities     2  
3 - Limited Self Care, Partly Confined To Bed     0  
4 - Completely Disabled, No Self Care     0  
Histopathological Grade  
[units: Participants]
 
G1 (well differentiated)     1  
G2 (moderately differentiated)     3  
G3 (poorly differentiated)     3  
G4 (undifferentiated)     1  
Unknown     9  
Tumor Histology  
[units: Participants]
 
Adenocarcinoma     15  
Bronchoalveolar Cell     1  
Large Cell     1  
Body Surface Area (BSA)  
[units: m²]
Mean ± Standard Deviation
  1.766  ± 0.1737  
Weight  
[units: kg]
Mean ± Standard Deviation
  68.22  ± 12.648  



  Outcome Measures
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1.  Primary:   Progression Free Survival for Subjects With Locally Advanced or Metastatic (Stage IIIB or Stage IV) Non-Small Cell Lung Cancer (NSCLC) After Systemic Treatment With Gemcitabine, Docetaxel, and Bevacizumab as First Line Therapy   [ Time Frame: 1 year post-registration ]

2.  Secondary:   Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: 1 year from start of treatment ]

3.  Secondary:   Overall Survival   [ Time Frame: 2 years post-registration ]


  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
Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Affairs study director
Organization: sanofi-aventis
e-mail: publicregistryUSMA@sanofi-aventis.com


No publications provided


Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00378573     History of Changes
Other Study ID Numbers: DOCET_L_00730
Study First Received: September 19, 2006
Results First Received: September 17, 2009
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration