Trial of Poor Performance Status Patients (ToPPS)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00892710
First received: April 30, 2009
Last updated: May 12, 2015
Last verified: May 2015
Results First Received: April 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Interventions: Drug: Pemetrexed
Drug: Bevacizumab
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
10 patients were enrolled/randomized, but never treated due to their reqeust, physician's request or if they were deemed ineligible. 4 of these patients were on the Pemetrexed/Bevacizumab arm and 6 were on the Pemetrexed/Bevacizumab/Carboplatin arm

Reporting Groups
  Description
Pemetrexed Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
Pemetrexed/Bevacizumab

Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days

Bevacizumab: 15 mg/kg IV every 21 days

Pemetrexed/Bevacizumab/Carboplatin

Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days

Bevacizumab: 15 mg/kg IV every 21 days

Carboplatin: AUC=5 IV every 21 days


Participant Flow:   Overall Study
    Pemetrexed     Pemetrexed/Bevacizumab     Pemetrexed/Bevacizumab/Carboplatin  
STARTED     48     59     55  
COMPLETED     0 [1]   0 [1]   0 [1]
NOT COMPLETED     48     59     55  
[1] Patients remained on study until disease progression or intolerable toxicity occurred



  Baseline Characteristics
  Hide 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.
Includes all patients who were enrolled (whether they recieved treatment or not)

Reporting Groups
  Description
Pemetrexed Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
Pemetrexed/Bevacizumab

Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days

Bevacizumab: 15 mg/kg IV every 21 days

Pemetrexed/Bevacizumab/Carboplatin

Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days

Bevacizumab: 15 mg/kg IV every 21 days

Carboplatin: AUC=5 IV every 21 days

Total Total of all reporting groups

Baseline Measures
    Pemetrexed     Pemetrexed/Bevacizumab     Pemetrexed/Bevacizumab/Carboplatin     Total  
Number of Participants  
[units: participants]
  48     63     61     172  
Age  
[units: years]
Median (Full Range)
  72    (51 to 84)     72    (50 to 90)     73    (48 to 90)     72    (48 to 90)  
Gender  
[units: participants]
       
Female     18     27     27     72  
Male     30     36     34     100  
Region of Enrollment  
[units: participants]
       
United States     48     63     61     172  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: 18 months ]

2.  Secondary:   Overall Response Rate (ORR), the Number of Patients Who Experience an Objective Benefit From Treatment   [ Time Frame: 18 months ]

3.  Secondary:   Time to Progression (TTP)   [ Time Frame: 18 months ]

4.  Secondary:   Time to Treatment Failure (TTTF)   [ Time Frame: 18 months ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: 18 months ]

6.  Secondary:   6-month and 12-month Overall Survival Probability   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


No publications provided


Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00892710     History of Changes
Other Study ID Numbers: SCRI LUN 196
Study First Received: April 30, 2009
Results First Received: April 24, 2015
Last Updated: May 12, 2015
Health Authority: United States: Food and Drug Administration