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

Sponsor:	M.D. Anderson Cancer Center
Collaborators:	National Cancer Institute (NCI) Schering-Plough
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00068575

Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa may interfere with the growth of the tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and interferon alfa with radiation therapy after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and interferon alfa together with radiation therapy works in treating patients who have undergone surgery for stage I, stage II, or stage III pancreatic cancer.

Condition	Intervention	Phase
Pancreatic Cancer	Biological: Recombinant Interferon Alfa Drug: Cisplatin Drug: Fluorouracil Radiation: Radiation Therapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Trial of Pancreaticoduodenectomy Plus Postoperative Cisplatin, Interferon Alfa-2b, and 5-FU Combined With Radiation Treatment for Patients With Resected Pancreatic Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Fluorouracil Cisplatin Interferon alfa-2a Interferon alfa-2b Interferon alfa-n1 Interferons

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number of Patients with Overall survival at 2 Years [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Toxicity by Patient [ Time Frame: Assessed every 2-3 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	29
Study Start Date:	May 2003
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Postoperative Chemoradiation Regimen Postoperative Cisplatin 30 mg/m^2 IV weekly for 6 doses, Interferon Alfa-2b 3 million units SQ MWF days 1-19 and 29-45 for 17 total doses, and 5-FU 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.	Biological: Recombinant Interferon Alfa 3 million units subcutaneously every other day (Monday, Wednesday and Friday) during Days 1-19 and 29-45, for 6 1/2 weeks totaling 17 doses. Other Names: Interferon alfa-2b IFN Drug: Cisplatin 30 mg/m^2 IV over 60 minutes on days 1, 8, 15, 29, 36, 43 - weekly for total 6 doses, during 5 1/2 weeks radiation therapy. Other Names: Platinol-AQ Platinol CDDP Drug: Fluorouracil 175 mg/m^2/day continuous infusion over 6 1/2 weeks for total 3 courses: Days 1-19 and 29-45, Days 71-108 and Days 127-168. Other Names: 5-fluorouracil Adrucil Efudex Radiation: Radiation Therapy External beam radiation on days 1-19 and days 29-45, 9 day treatment break on day 20. Other Names: RT Radiatherapy

Arms

Assigned Interventions

Experimental: Postoperative Chemoradiation Regimen

Postoperative Cisplatin 30 mg/m^2 IV weekly for 6 doses, Interferon Alfa-2b 3 million units SQ MWF days 1-19 and 29-45 for 17 total doses, and 5-FU 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.

Biological: Recombinant Interferon Alfa

3 million units subcutaneously every other day (Monday, Wednesday and Friday) during Days 1-19 and 29-45, for 6 1/2 weeks totaling 17 doses.

Other Names:

Interferon alfa-2b
IFN

Drug: Cisplatin

30 mg/m^2 IV over 60 minutes on days 1, 8, 15, 29, 36, 43 - weekly for total 6 doses, during 5 1/2 weeks radiation therapy.

Other Names:

Platinol-AQ
Platinol
CDDP

Drug: Fluorouracil

175 mg/m^2/day continuous infusion over 6 1/2 weeks for total 3 courses: Days 1-19 and 29-45, Days 71-108 and Days 127-168.

Other Names:

5-fluorouracil
Adrucil
Efudex

Radiation: Radiation Therapy

External beam radiation on days 1-19 and days 29-45, 9 day treatment break on day 20.

Other Names:

RT
Radiatherapy

Detailed Description:

OBJECTIVES:

Primary

Determine the overall survival of patients with previously resected pancreatic adenocarcinoma treated with postoperative cisplatin, interferon alfa, fluorouracil, and concurrent radiotherapy.
Determine the toxic effects of this regimen in these patients.

Secondary

Determine the disease-specific, biochemical failure-free, and symptom/treatment-free survival of patients treated with this regimen.
Determine the quality of life of patients treated with this regimen.

OUTLINE:

Chemoradiotherapy: Patients receive fluorouracil IV continuously and interferon alfa subcutaneously (SQ) 3 times per week (total of 17 doses) on days 1-19 and 29-45 and cisplatin IV over 6 hours on days 1, 8, 15, 29, 36 and 43. Patients also undergo concurrent radiotherapy once daily, 5 days a week in weeks 1-3 and 5-7 (28 fractions).
Post-chemoradiotherapy fluorouracil: Patients receive fluorouracil IV continuously on days 71-108 and 127-168.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Eligibility

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

Criteria

Inclusion Criteria:

Biopsy proven completely resected (R0 or R1) pancreatic adenocarcinoma of the pancreatic head or uncinate process (AJCC Stage I-III). Surgery (pancreaticoduodenectomy) may be performed at M. D. Anderson Cancer Center or prior to referral to M. D. Anderson Cancer Center. Protocol treatment must begin within 12 weeks of surgery.
Postoperative (pre-treatment) CT scan without evidence of radiographically defineable residual primary/metastatic disease or clinically significant post-surgical changes.
Staging studies completed within three weeks +/- 3 days of protocol registration.
Hb >9.0 g/%, WBC >3,000 cells/mm3 (ANC >1,500 cells/mm3), platelets >75,000 cells/mm3.
Postoperative serum CA 19-9 < 100.
Performance status: Zubrod 0 or 1.
Creatinine £1.5 mg/dL and calculated or measured creatinine clearance (CrCl) of 60 ml/min or greater by the following formula: CrCl = (140 - age) x Wt (kg) x 0.85 (female) OR x 1.00 (male) 72 x serum creatinine
Patients should have bilateral renal function, as determined on excretory urogram (IVP) or abdominal CT, or ³ 2/3 of one functioning kidney must be able to be shielded from the radiation beam.
No acute infections at the time of therapy initiation.
Women of childbearing potential must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent.
Patients must sign a study-specific consent form, which is attached to this protocol.
Patients with a prior history of non-pancreatic malignancy who are free of disease from their primary cancer may be eligible at the discretion of the study chair.

Exclusion Criteria:

Residual (clinical or CT definable) metastatic or incompletely resected local disease.
Patients with positive peritoneal cytology (for adenocarcinoma) detected at laparotomy for pancreaticoduodenectomy or as part of prior laparoscopic assessment of peritoneal cytology.
Patients with a history of hypersensitivity to interferon alfa-2b.
Patients with significant cardiovascular disease, such as unstable angina or congestive heart failure.
Pregnancy or breastfeeding.
Patients with severe pulmonary disease.
Children under the age of 18 are excluded (as the disease is rare and toxicity profile of this regimen untested in pediatric patients).
Presence or history of severe depression.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068575

Locations

United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Schering-Plough

Investigators

Study Chair:

Peter W. Pisters, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

UT MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Peter W. Pisters, M.D., UT MD 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
Last Updated:	December 10, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:

Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b

Interferons
Fluorouracil
Cisplatin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 09, 2012