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Paclitaxel, Bevacizumab and Pemetrexed in Patients With Untreated, Advanced Non-Small Cell Lung Cancer Using Web-Based Data Collection, Patient Self-Reporting of Adverse Effects and Automated Response Assessment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00807573
First received: December 11, 2008
Last updated: November 24, 2015
Last verified: November 2015
Results First Received: October 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: Paclitaxel
Drug: Pemetrexed
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
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Reporting Groups
  Description
Paclitaxel, Bevacizumab & Pemetrexed Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.

Participant Flow:   Overall Study
    Paclitaxel, Bevacizumab & Pemetrexed  
STARTED     44  
COMPLETED     42  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Adverse Event                 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.
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Reporting Groups
  Description
Paclitaxel, Bevacizumab & Pemetrexed Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced NSCLC. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1, 15 and 19.

Baseline Measures
    Paclitaxel, Bevacizumab & Pemetrexed  
Number of Participants  
[units: participants]
  44  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     28  
>=65 years     16  
Gender  
[units: participants]
 
Female     22  
Male     22  
Region of Enrollment  
[units: participants]
 
United States     44  



  Outcome Measures

1.  Primary:   Objective Response Rate (CR + PR by RECIST) Paclitaxel, Pemetrexed, and Bevacizumab in Patients With Advanced Non-Small Lung Cancer Who Have Received no Prior Treatment for Metastatic Disease.   [ Time Frame: 2 years ]


  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: Dr. Maria Pietanza, Assistant Attending
Organization: Memorial Sloan Kettering Cancer Center
phone: +1646-888-4203
e-mail: PietanzM@mskcc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00807573     History of Changes
Other Study ID Numbers: 08-109
Study First Received: December 11, 2008
Results First Received: October 19, 2015
Last Updated: November 24, 2015
Health Authority: United States: Institutional Review Board