Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	ACOSOG-Z05031 NCT00059826

Objectives

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

Entry 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

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

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/mm³
• Absolute neutrophil count greater than 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Overall survival at 18 months

Toxicity
Disease-free survival
Local-regional disease control
Distant disease control

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.

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.

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Vincent Picozzi, MD, Protocol chair		Ph: 206-223-6193 Email: hemvjp@vmmc.org

Registry Information
Official Title		A Phase II Study of Interferon-Based Chemoradiation in Patients with Resected Pancreatic Adenocarcinoma
Trial Start Date		2003-03-17
Registered in ClinicalTrials.gov		NCT00059826
Date Submitted to PDQ		2003-03-06
Information Last Verified		2006-01-01
NCI Grant/Contract Number		CA076001

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