Chemotherapy and Radiation Following Pancreatic Surgery - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00660270

Purpose

Primary Objective: To describe the overall survival and disease-free survival in pancreatic cancer patients treated with adjuvant chemoradiation with cisplatin, continuous infusion 5FU and interferon alpha followed by gemcitabine.

Secondary Objective: To describe the toxicities associated with adjuvant chemoradiation with cisplatin. 5FU and interferon alfa followed by gemcitabine in patients with pancreatic cancers.

Condition	Intervention	Phase
Pancreatic Cancer	Procedure: Pancreatic Resection Drug: Cisplatin, 5-FU and Alpha-Interferon Drug: Gemcitabine	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine Fluorouracil Interferon alfa-2b Interferons Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial Of Adjuvant Chemoradiation Following Pancreatic Resection For Adenocarcinomas Of The Pancreas Using 3-D Conformal Radiation With Cisplatin, 5fu, And Alpha- Interferon As Radiosensitizing Agents Followed By Gemcitabine

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Primary: To describe the overall survival and disease-free survival in pancreatic cancer patients treated with adjuvant chemoradiation with cisplatin, continuous infusion 5FU and interferon alpha followed by gemcitabine. [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary: To describe the toxicities associated with adjuvant chemoradiation with cisplatin. 5FU and interferon alfa followed by gemcitabine in patients with pancreatic cancers. [ Designated as safety issue: Yes ]

Enrollment:	53
Study Start Date:	May 2002
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Surgery followed by Radiation Therapy followed by Chemotherapy with Cisplatin, 5-FU, and Alpha-Interferon with concurrent radiation for 6 weeks followed by Gemcitabine for 2 cycles.	Procedure: Pancreatic Resection Drug: Cisplatin, 5-FU and Alpha-Interferon Cisplatin: Cisplatin will be given as a 1 hour intravenous infusion at 25 mg/m2 on days 1, 8, 15, 22, 29 and 36 during radiation. Pre- and post chemotherapy hydration as well as standard antiemetic regimens will be given. 5-fluorouracil: 5-FU will be given as a continuous intravenous infusion at 175 mg/m2/d on days 1-38 without interruption during radiation. 5FU infusion will terminate on the last day of radiation. Patients will need a central line and portable infusion pump. Alpha-interferon (Intron A): Intron A will be given as a subcutaneous injection at 3,000,000 Units on Mondays, Wednesdays and Fridays during radiation therapy. Drug: Gemcitabine Gemcitabine: Gemcitabine will be given as an intravenous 30-minute infusion at 1000/mg/m2 4 weeks after the conclusion of radiation ( on a 3 weeks on/ 1 week off schedule for 2 cycles) on days 71, 78, 85, 99, 106, 113.

Arms

Assigned Interventions

1: Experimental

Surgery followed by Radiation Therapy followed by Chemotherapy with Cisplatin, 5-FU, and Alpha-Interferon with concurrent radiation for 6 weeks followed by Gemcitabine for 2 cycles.

Procedure: Pancreatic Resection Drug: Cisplatin, 5-FU and Alpha-Interferon

Cisplatin: Cisplatin will be given as a 1 hour intravenous infusion at 25 mg/m2 on days 1, 8, 15, 22, 29 and 36 during radiation. Pre- and post chemotherapy hydration as well as standard antiemetic regimens will be given.

5-fluorouracil: 5-FU will be given as a continuous intravenous infusion at 175 mg/m2/d on days 1-38 without interruption during radiation. 5FU infusion will terminate on the last day of radiation. Patients will need a central line and portable infusion pump.

Alpha-interferon (Intron A): Intron A will be given as a subcutaneous injection at 3,000,000 Units on Mondays, Wednesdays and Fridays during radiation therapy.

Drug: Gemcitabine

Gemcitabine: Gemcitabine will be given as an intravenous 30-minute infusion at 1000/mg/m2 4 weeks after the conclusion of radiation ( on a 3 weeks on/ 1 week off schedule for 2 cycles) on days 71, 78, 85, 99, 106, 113.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Resected adenocarcinoma of the pancreas
ECOG performance status 0 or 1
No prior chemotherapy or radiation therapy for cancer within the last five years.
Prior history of other malignancies allowable, if stable or requiring no active therapy.
Absolute neutrophil count >/= 1,500/mm3, platelet count >/= 100,000/mm3, and hemoglobin >/= 9 g/dL.
Serum creatinine </= 2 mg/dL.
Serum bilirubin </= 3.0 mg/dL.
Serum transaminases ( SGOT and SGPT) </= 5-fold the institutional upper limits.
No co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
Able to sign an informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660270

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63119

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

David Linehan, MD

Washington University School of Medicine

More Information

Publications indexed to this study:

Linehan DC, Tan MC, Strasberg SM, Drebin JA, Hawkins WG, Picus J, Myerson RJ, Malyapa RS, Hull M, Trinkaus K, Tan BR Jr. Adjuvant interferon-based chemoradiation followed by gemcitabine for resected pancreatic adenocarcinoma: a single-institution phase II study. Ann Surg. 2008 Aug;248(2):145-51.

Responsible Party:	Washington University School of Medicine ( David Linehan, MD )
Study ID Numbers:	02-0307
Study First Received:	April 11, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00660270
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

Chemotherapy
Radiation

Study placed in the following topic categories:

Interferon-alpha
Interferon Type I, Recombinant
Digestive System Neoplasms
Pancreatic Neoplasms
Interferons
Endocrine System Diseases
Pancrelipase
Digestive System Diseases
Cisplatin

Fluorouracil
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Interferon Alfa-2a
Adenocarcinoma
Gemcitabine
Interferon Alfa-2b
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents

Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009