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Trial record 76 of 579 for:    Advanced | cancer | bevacizumab

A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00661778
Recruitment Status : Completed
First Posted : April 18, 2008
Results First Posted : July 10, 2014
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Interventions: Drug: Bevacizumab
Drug: Cisplatin
Drug: Docetaxel

  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
The data listed in Participant Flow are for discontinuation from treatment, not discontinuation from the study. Data for discontinuation from the study are not available.

Reporting Groups
  Description
Bevacizumab + Cisplatin + Docetaxel Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.

Participant Flow:   Overall Study
    Bevacizumab + Cisplatin + Docetaxel
STARTED   50 
COMPLETED   0 
NOT COMPLETED   50 
Disease Progression                23 
Adverse Event                18 
Reason not Specified                6 
Protocol Violation                2 
Withdrawal of Consent                1 



  Baseline Characteristics

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.
Intent-to-treat population: All enrolled participants who received at least 1 treatment.

Reporting Groups
  Description
Bevacizumab + Cisplatin + Docetaxel Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.

Baseline Measures
   Bevacizumab + Cisplatin + Docetaxel 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.31  (9.54) 
Gender 
[Units: Participants]
 
Female   12 
Male   38 


  Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: Baseline to the end of the study (up to 4 years) ]

2.  Secondary:   Percentage of Participants With an Objective Response   [ Time Frame: Baseline to the end of the study (up to 4 years) ]

3.  Secondary:   Overall Survival   [ Time Frame: Baseline to the end of the study (up to 4 years) ]

4.  Secondary:   1-year Survival   [ Time Frame: Baseline to 1 year ]

5.  Secondary:   Duration of the Objective Response   [ Time Frame: Baseline to the end of the study (up to 4 years) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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 Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00661778     History of Changes
Other Study ID Numbers: ML20081
2006-005619-88 ( EudraCT Number )
First Submitted: April 17, 2008
First Posted: April 18, 2008
Results First Submitted: May 27, 2014
Results First Posted: July 10, 2014
Last Update Posted: July 10, 2014