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

This study has been completed.

Study NCT00068575 Information provided by M.D. Anderson Cancer Center

First Received on September 10, 2003. Last Updated on January 23, 2012 History of Changes

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

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 14k, 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

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) ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

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
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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:	January 23, 2012
Health Authority:	United States: Food and Drug Administration