PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00454779
First received: March 29, 2007
Last updated: July 22, 2014
Last verified: July 2014
Results First Received: October 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
Interventions: Drug: Cisplatin
Drug: Panitumumab
Drug: Docetaxel

  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
Subjects were enrolled from 29 January 2007 to 1 September 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The planned number of subjects to enroll was 110. The actual number of subjects enrolled was 113.

Reporting Groups
  Description
Panitumumab Plus Chemotherapy Panitumumab + Docetaxel + Cisplatin, experiment
Chemotherapy Alone Docetaxel + Cisplatin, control

Participant Flow for 2 periods

Period 1:   First-line Treatment Phase
    Panitumumab Plus Chemotherapy     Chemotherapy Alone  
STARTED     56     57  
Received Study Medication     56     55  
COMPLETED     51 [1]   49 [1]
NOT COMPLETED     5     8  
Lack of Efficacy                 0                 2  
Withdrawal by Subject                 2                 4  
Lost to Follow-up                 1                 0  
Protocol Violation                 0                 1  
Ended follow-up prior to analysis                 1                 1  
Ongoing                 1                 0  
[1] Disease progression (radiographically determined) or death

Period 2:   Second-line Treatment Phase
    Panitumumab Plus Chemotherapy     Chemotherapy Alone  
STARTED     0 [1]   30 [2]
COMPLETED     0 [3]   27 [3]
NOT COMPLETED     0     3  
Withdrawal by Subject                 0                 1  
Ended follow-up prior to analysis                 0                 1  
Ongoing                 0                 1  
[1] Subjects in this arm do not have second-line treatment period
[2] Second-line Panitumumab Monotherapy
[3] Disease progression (radiographically determined) or death



  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.
No text entered.

Reporting Groups
  Description
Panitumumab Plus Chemotherapy Panitumumab + Docetaxel + Cisplatin, experiment
Chemotherapy Alone Docetaxel + Cisplatin, control
Total Total of all reporting groups

Baseline Measures
    Panitumumab Plus Chemotherapy     Chemotherapy Alone     Total  
Number of Participants  
[units: participants]
  56     57     113  
Age  
[units: Years]
Mean ± Standard Deviation
  58.2  ± 8.6     58.9  ± 7.4     58.6  ± 8.0  
Gender  
[units: Participants]
     
Female     9     5     14  
Male     47     52     99  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival (PFS) During the First-line Treatment Phase   [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ]

2.  Secondary:   Overall Response Rate (ORR) During the First-line Treatment Phase   [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ]

3.  Secondary:   Rate of Disease Control (RDC) During the First-line Treatment Phase   [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ]

4.  Secondary:   Duration of Response (DOR) During the First-line Treatment Phase   [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ]

5.  Secondary:   Time to Response (TTR) During the First-line Treatment Phase   [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ]

6.  Secondary:   Overall Survival (OS) for the First-line Treatment   [ Time Frame: Until death, up to 67 months ]

7.  Secondary:   Progression Free Survival (PFS) During the Second-line Treatment Phase   [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ]

8.  Secondary:   Overall Response Rate (ORR) During the Second-line Treatment Phase   [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ]

9.  Secondary:   Rate of Disease Control (RDC) During the Second-line Treatment Phase   [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ]

10.  Secondary:   Duration of Response (DOR) During the Second-line Treatment Phase   [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ]

11.  Secondary:   Time to Response (TTR) During the Second-line Treatment Phase   [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ]

12.  Secondary:   Overall Survival (OS) for the Second-line Treatment   [ Time Frame: Until death, up to 57 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: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications:
Wirth L. PARTNER: A study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer: the PARTNER trial. Community Oncology;2008;5(Supp 14):1-4


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00454779     History of Changes
Other Study ID Numbers: 20050236
Study First Received: March 29, 2007
Results First Received: October 11, 2013
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board