Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer (UGIH09067)

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Aram Hezel, University of Rochester
ClinicalTrials.gov Identifier:
NCT01308840
First received: August 9, 2010
Last updated: July 7, 2016
Last verified: July 2016
Results First Received: May 11, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Biliary Tract Cancer
Gallbladder Cancer
Interventions: Drug: Panitumumab
Drug: oxaliplatin
Drug: gemcitabine

  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
38 participants were screened.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
5 subjects were not eligible to enroll. 2 participants did not receive the intervention.

Reporting Groups
  Description
Panitumumab

Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)

Panitumumab: Day 1 and 15 = 6 mg/kg IV

oxaliplatin: Days 1 and 15 = 85mg/m2 IV

gemcitabine: Days 1 and 15 = 1000 mg/m2 IV


Participant Flow:   Overall Study
    Panitumumab  
STARTED     31  
COMPLETED     31  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
Panitumumab

Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)

Panitumumab: Day 1 and 15 = 6 mg/kg IV

oxaliplatin: Days 1 and 15 = 85mg/m2 IV

gemcitabine: Days 1 and 15 = 1000 mg/m2 IV


Baseline Measures
    Panitumumab  
Number of Participants  
[units: participants]
  31  
Age  
[units: years]
Median (Full Range)
  61  
  (36 to 74)  
Gender  
[units: participants]
 
Female     14  
Male     17  
Region of Enrollment  
[units: participants]
 
United States     31  
Eastern Cooperative Oncology Group (ECOG) Performance status [1]
[units: participants]
 
0     10  
1     21  
Extent of disease  
[units: participants]
 
locally advanced     2  
metastatic     29  
primary tumor site  
[units: participants]
 
intrahepatic cholangiocarcinoma     25  
gallbladder     3  
extrahepatic cholantiocarcinoma     3  
metastases  
[units: participants]
 
lymph nodes     24  
lung     8  
bone     4  
omentum/peritoneal     4  
adrenal     3  
pelvic soft tissue     1  
[1] ECOG describes a patient’s level of functioning in terms of their ability to care for themself, daily activity, and physical ability. It ranges from 0-5 with higher numbers indicating reduced ability to care for themself.



  Outcome Measures
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1.  Primary:   The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.   [ Time Frame: end of cycle 2 of treatment ]

2.  Secondary:   Median Progression Free Survival   [ Time Frame: time to cancer progression or death ]

3.  Secondary:   Median Overall Survival   [ Time Frame: enrollment until date of death ]

4.  Secondary:   The Number of Participants Who Experience an Adverse Event   [ Time Frame: baseline to study completion ]


  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: Aram F Hezel
Organization: University of Rochester
phone: 585-275-5823
e-mail: aram_hezel@urmc.rochester.edu



Responsible Party: Aram Hezel, University of Rochester
ClinicalTrials.gov Identifier: NCT01308840     History of Changes
Other Study ID Numbers: UGIH09067
Study First Received: August 9, 2010
Results First Received: May 11, 2016
Last Updated: July 7, 2016
Health Authority: United States: Food and Drug Administration