Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer - Full Text View

Sponsors and Collaborators:	American College of Surgeons National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00059826

Purpose

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

PURPOSE: Phase II trial to study the effectiveness of adjuvant chemoradiotherapy and interferon alfa in treating patients who have resected stage I, stage II, or stage III pancreatic cancer.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: cisplatin Drug: fluorouracil Drug: recombinant interferon alfa Procedure: adjuvant therapy Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Interferon-Based Chemoradiation in Patients With Resected Pancreatic Adenocarcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival at 18 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Disease-free survival [ Designated as safety issue: No ]
Local-regional disease control [ Designated as safety issue: No ]
Distant disease control [ Designated as safety issue: No ]

Study Start Date:

March 2003

Detailed Description:

OBJECTIVES:

Determine the disease-free and overall survival of patients with resected pancreatic adenocarcinoma treated with adjuvant chemoradiotherapy comprising fluorouracil, cisplatin, and interferon alfa.
Determine the rate and severity of acute and late toxic effects in patients treated with this regimen.
Determine the local-regional disease control and distant disease control in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Chemoradiotherapy (CRT): Patients receive fluorouracil IV continuously on days 1-38; cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36; and interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, and 38. Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38.
Post-CRT chemotherapy: Beginning 4-6 weeks after the completion of CRT, patients receive fluorouracil IV continuously on days 1-42. Treatment repeats every 56 days for a total of two courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 93 patients will be accrued for this study within 2 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the head of the pancreas
- Stage I, II, or III (T1-4, N0-1, M0)
- No recurrent pancreatic cancer
Must have undergone a potentially curative gross total resection by pancreaticoduodenectomy within the past 56 days
- Must have R0 (no residual tumor) or R1 (microscopic residual tumor) grade disease post-resection
No pancreaticoduodenectomy histopathology indicating any of the following types:
- Adenosquamous carcinoma
- Ampullary carcinoma
- Carcinoid tumor
- Cystadenocarcinoma
- Cystadenoma
- Distal common bile duct carcinoma
- Duodenal carcinoma
- Islet cell carcinoma
No metastatic disease by CT scan of the chest and CT scan with intravenous contrast (or MRI) of abdomen/pelvis

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1 OR
Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

WBC at least 3,000/mm^3
Absolute neutrophil count greater than 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin greater than 9.5 g/dL

Hepatic

Bilirubin no greater than 3 mg/dL
AST and ALT no greater than 2 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2 times ULN

Renal

Creatinine no greater than 1.5 times ULN

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Stable or increasing weight within 14 days before start of study treatment (otherwise supplemental nutrition, such as feeding jejunostomy, percutaneous endoscopic gastrostomy, or total parenteral nutrition, must be initiated)
No evidence of recurrence of any prior malignancy
No other malignancies within the past 5 years except successfully treated carcinoma in situ of the cervix, lobular carcinoma in situ of the breast, or nonmelanoma skin cancer
No preexisting psychiatric condition (especially depression) or a history of severe psychiatric disorders

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior biologic or immunologic therapies
No concurrent biological response modifiers for pancreatic cancer
No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
No concurrent oprelvekin

Chemotherapy

No prior systemic chemotherapy for pancreatic cancer

Endocrine therapy

No concurrent dexamethasone

Radiotherapy

No prior radiotherapy for pancreatic cancer
No prior external beam photon (x-ray) therapy to the chest, abdomen, or pelvis
No concurrent intensity modulated radiotherapy

Surgery

See Disease Characteristics

Other

Underwent potentially curative therapy for any prior malignancies
No prior chronic immunosuppressive therapy (e.g., prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality
No concurrent theophylline
No concurrent aminoglycoside antibiotics
No concurrent halogenated antiviral agents (e.g., sorivudine)
No other concurrent investigational drugs for pancreatic cancer
No other concurrent systemic or loco-regional therapy for pancreatic cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059826

Locations

United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kentucky
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Minnesota
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States, 55455
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

American College of Surgeons

National Cancer Institute (NCI)

Investigators

Study Chair:

Vincent J. Picozzi, MD

Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center

More Information

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

Publications of Results:

Picozzi VJ, Abrams RA, Traverso LW, et al.: ACOSOG Z05031: initial report of a multicenter, phase II trial of a novel chemoradiation protocol using cisplatin, 5-FU, and alpha- interferon as adjuvant therapy for resected pancreas cancer. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-125, 2008.

Picozzi VJ, Abrams RA, Traverso LW, et al.: ACOSOG Z05031: report on a multicenter, phase II trial for adjuvant therapy of resected pancreatic cancer using cisplatin, 5- FU, and alpha-interferon. [Abstract] J Clin Oncol 26 (Suppl 15): A-4505, 2008.

Study ID Numbers:	CDR0000298776, ACOSOG-Z05031
Study First Received:	May 6, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00059826
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

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
Adenocarcinoma
Interferon Alfa-2a
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
Immunosuppressive Agents

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

ClinicalTrials.gov processed this record on January 16, 2009