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Trial of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation in Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT01128387
Recruitment Status : Terminated (slow accrual)
First Posted : May 21, 2010
Results First Posted : January 23, 2018
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cancer
Intervention: Drug: Panitumumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the University of Wisconsin Hospital and Clinics between 2010 and 2013.

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
Dose Level 1

Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.

1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU (Fluorouracil)

Dose Level -1

Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.

1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU


Participant Flow:   Overall Study
    Dose Level 1   Dose Level -1
STARTED   5   6 
COMPLETED   5   5 
NOT COMPLETED   0   1 
Physician Decision                0                1 



  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
Dose Level 1

Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.

1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU

Dose Level -1

Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.

1.5mg/kg Panitumumab, 60mg/m2 cisplatin, 750mg/m2 5FU

Total Total of all reporting groups

Baseline Measures
   Dose Level 1   Dose Level -1   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   6   11 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      3  60.0%      3  50.0%      6  54.5% 
>=65 years      2  40.0%      3  50.0%      5  45.5% 
Age 
[Units: Years]
Mean (Full Range)
 60.3 
 (51 to 69) 
 62.6 
 (53 to 69) 
 61.5 
 (51 to 69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      5 100.0%      6 100.0%      11 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      5 100.0%      6 100.0%      11 100.0% 
Unknown or Not Reported      0   0.0%      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   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      5 100.0%      6 100.0%      11 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   5   6   11 


  Outcome Measures

1.  Primary:   MTD of Panitumumab in Combination With Cisplatin/Fluorouracil and Radiation for Locally Advanced Esophageal Cancer Determined by Number of Participants Experiencing DLT   [ Time Frame: approximately 18 weeks ]

2.  Secondary:   Pathologic Response   [ Time Frame: 20 weeks. ]


  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
The Standard of Care changed during this protocol, and the protocol was terminated prematurely.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mark Ritter
Organization: University of Wisconsin Carbone Cancer Center
phone: 608-263-8500
e-mail: ritter@humonc.wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01128387     History of Changes
Other Study ID Numbers: H-2009-0214
RO09211 ( Other Identifier: UWCCC )
First Submitted: May 17, 2010
First Posted: May 21, 2010
Results First Submitted: November 8, 2017
Results First Posted: January 23, 2018
Last Update Posted: March 14, 2018