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A Trial for Treatment of Stage IIIB or IV Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00735891
Recruitment Status : Terminated (Not Stated)
First Posted : August 15, 2008
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Chandra P. Belani, Milton S. Hershey Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Interventions: Drug: First-Line Treatment
Drug: Maintenance
Drug: Second-Line Treatment

  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
No text entered.

Reporting Groups
  Description
First Line Treatment

All patients will receive first-line treatment in 21-day cycles for up to 6 cycles. All first-line medications are administered intravenously on Day 1 of each cycle. Response is assessed every 2 cycles until disease progression.

First-Line Treatment: Docetaxel 75 mg/m2, Carboplatin AUC=6,Bevacizumab 15 mg/kg administered in 21-day cycles on day 1 of each cycle.

Maintenance

Patients who have not progressed will continue on bevacizumab maintenance

Maintenance: Bevacizumab 15 mg/kg maintenance in 21 day cycles for up to 18 cycles.

Second-Line Treatment

Upon disease progression, eligible patients will be randomized for second-line treatment to one of two treatment arms. All second line medications are administered intravenously on Day 1 of each 21 day cycle until disease progression. Response is assessed every 2 cycles.

Second-Line Treatment: Arm A: Pemetrexed 500 mg/m2 plus Bevacizumab 15 mg/kg administered in 21 day cycles on Day 1 of each cycle. Arm B: Pemetrexed 500 mg/m2 administered in 21 day cycles on Day 1 of each cycle.


Participant Flow:   Overall Study
    First Line Treatment   Maintenance   Second-Line Treatment
STARTED   2   0   0 
COMPLETED   2   0   0 
NOT COMPLETED   0   0   0 



  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.
No text entered.

Reporting Groups
  Description
First Line Treatment

All patients will receive first-line treatment in 21-day cycles for up to 6 cycles. All first-line medications are administered intravenously on Day 1 of each cycle. Response is assessed every 2 cycles until disease progression.

First-Line Treatment: Docetaxel 75 mg/m2, Carboplatin AUC=6,Bevacizumab 15 mg/kg administered in 21-day cycles on day 1 of each cycle.

Maintenance

Patients who have not progressed will continue on bevacizumab maintenance

Maintenance: Bevacizumab 15 mg/kg maintenance in 21 day cycles for up to 18 cycles.

Total Total of all reporting groups

Baseline Measures
   First Line Treatment   Maintenance   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   0   2 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%   0      0   0.0% 
Between 18 and 65 years      1  50.0%   0      1  50.0% 
>=65 years      1  50.0%   0      1  50.0% 
Age 
[Units: Years]
Median (Standard Deviation)
 70  (31)      70  (31) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  50.0%   0      1  50.0% 
Male      1  50.0%   0      1  50.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%   0      0   0.0% 
Not Hispanic or Latino      2 100.0%   0      2 100.0% 
Unknown or Not Reported      0   0.0%   0      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%   0      0   0.0% 
Asian      0   0.0%   0      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%   0      0   0.0% 
Black or African American      0   0.0%   0      0   0.0% 
White      2 100.0%   0      2 100.0% 
More than one race      0   0.0%   0      0   0.0% 
Unknown or Not Reported      0   0.0%   0      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   2      2 


  Outcome Measures

1.  Primary:   Survival   [ Time Frame: 24 months ]

2.  Secondary:   Progression-free Survival Time.   [ Time Frame: 12 months ]


  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 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: Dr. Chandra Belani
Organization: MS HERSHEY MC
phone: 717-531-1003
e-mail: cbelani@psu.edu



Responsible Party: Chandra P. Belani, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00735891     History of Changes
Other Study ID Numbers: PSHCI 08-009
First Submitted: August 14, 2008
First Posted: August 15, 2008
Results First Submitted: August 21, 2017
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017