Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00059826
First received: May 6, 2003
Last updated: June 12, 2015
Last verified: June 2015
  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
Biological: interferon-alfa-2b
Drug: cisplatin
Drug: 5-fluorouracil
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Interferon-Based Adjuvant Chemoradiation in Patients With Resected Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Overall survival at 18 months [ Time Frame: at 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: at 18 months ] [ Designated as safety issue: Yes ]
  • Disease-free survival [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
  • Local-regional disease control [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
  • Distant disease control [ Time Frame: at 18 months ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: March 2003
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interferon-based chemoradiation therapy

Cycle 1: Chemoradiotherapy (CRT)

  • 5-fluorouracil continuous infusion (CI) via an ambulatory infusion pump into a central venous catheter at 175 mg/m2/day for 38 consecutive days, unless toxicity occurs
  • cisplatin given on the first day only of each week of this cycle (days 1, 8, 15, 22, 29, 36)
  • IFN-alpha-2b 3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks
  • XRT 5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday - Friday, for 5½ weeks

Cycles 2 and 3: Post-CRT Chemotherapy

Post-CRT chemotherapy starts 4 - 6 weeks after completion of Cycle 1, unless the study physician deems further delay is necessary. Patients will be given 2 cycles of chemotherapy (cycles 2 and 3).

-- 5-fluorouracil continuous infusion via an ambulatory infusion pump into a central venous catheter at 200 mg/m2/day for 6 weeks followed by 2 weeks of rest

Biological: interferon-alfa-2b
IV
Other Name: IFN-alpha-2b
Drug: cisplatin
IV
Drug: 5-fluorouracil
IV
Other Name: 5-FU
Radiation: radiation therapy
Other Name: XRT

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Vincent J. Picozzi, MD Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center
  More Information

Additional Information:
Publications:
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.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00059826     History of Changes
Other Study ID Numbers: ACOSOG-Z05031, CDR0000298776
Study First Received: May 6, 2003
Last Updated: June 12, 2015
Health Authority: United States: Central Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Fluorouracil
Interferon-alpha
Interferons
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015