Chemotherapy, Interferon Alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborators:
Schering-Plough
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00068575
First received: September 10, 2003
Last updated: February 13, 2012
Last verified: February 2012
Results First Received: January 23, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Biological: Recombinant Interferon Alfa
Drug: Cisplatin
Drug: Fluorouracil
Radiation: Radiation Therapy

  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
Recruitment Period: May 31, 2002 to January 14, 2010. All recruitment was done at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 29 participants who were enrolled, one patient dropped out prior to receiving study treatment.

Reporting Groups
  Description
Postoperative Chemoradiation Regimen Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.

Participant Flow:   Overall Study
    Postoperative Chemoradiation Regimen  
STARTED     28  
COMPLETED     28  
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
Postoperative Chemoradiation Regimen Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.

Baseline Measures
    Postoperative Chemoradiation Regimen  
Number of Participants  
[units: participants]
  28  
Age  
[units: years]
Median ( Full Range )
  60.5  
  ( 39 to 69 )  
Gender  
[units: participants]
 
Female     8  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     28  



  Outcome Measures

1.  Primary:   Median Overall Survival (OS)   [ Time Frame: Participants followed till disease progression or death (approximately 6 years) ]


  Serious Adverse Events


  Other Adverse Events


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


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.  


Results Point of Contact:  
Name/Title: Peter Pisters, MD / Professor
Organization: UT MD Anderson Cancer Center
e-mail: asanmigu@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00068575     History of Changes
Obsolete Identifiers: NCT01053351
Other Study ID Numbers: ID02-040, P30CA016672, MDA-ID-02040, CDR0000327752
Study First Received: September 10, 2003
Results First Received: January 23, 2012
Last Updated: February 13, 2012
Health Authority: United States: Food and Drug Administration