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

Pancreatic Cancer Clinical Trial

Official title:

A Phase II Study of Interferon-Based Adjuvant Chemoradiation in Patients With Resected Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059826
• Other study ID #: ACOSOG-Z05031
• Secondary ID: CDR0000298776
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2003
• Last updated: December 5, 2016
• Start date: March 2003
• Est. completion date: February 2011

Study information

• Verified date: December 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 2011
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient must be > 18 years of age.

2. Patient must have a documented ECOG/Zubrod performance status of 0 or 1, within 7 days prior to registration.

3. Patient must have pathological stage T1-3, N0-1, M0 adenocarcinoma of the head of the pancreas according to the American Joint Committee on Cancer (AJCC) staging system.

• NOTE: The pathology report must be submitted to ACOSOG on the Pathology Report Shuttle CRF.

4. Patient must have undergone a potentially curative gross total resection by pancreaticoduodenectomy (includes R0 [no residual tumor] or R1 [microscopic residual tumor]) within 56 days prior to beginning treatment. NOTE: The operative report must be submitted to ACOSOG on the Operative Report Shuttle CRF.

5. Patient must have stable or increasing weight in the 14 days prior to the start of treatment, otherwise supplemental nutrition (e.g. feeding jejunostomy, PEG, TPN) must be initiated prior to the start of treatment.6. Patient must have adequate bone marrow, hepatic and renal function, within 7 days prior to registration:

• WBC > 3,000 mm^3

• ANC > 1,500 mm^3

• hemoglobin > 9.5 mg/dl

• platelet count > 100,000 mm^3

• total bilirubin < 3 mg/dl

• AST (SGOT) < 2.0 times institutional upper limit of normal (ULN)

• ALT (SGPT) < 2.0 times institutional ULN

• alkaline phosphatase < 2.0 times institutional ULN

• serum creatinine < 1.5 times institutional ULN

7. Patient must have a baseline diagnostic CT scan of the chest and CT scan with IV contrast (or MRI) of abdomen/pelvis, within 30 days prior to registration, to exclude metastatic disease.

8. If female of childbearing potential, patient must have a negative urine or serum pregnancy test, within 7 days prior to registration. NOTE: Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered not of childbearing potential.

9. Patient (male or female) of reproductive potential must agree to use medically acceptable contraception during the study. NOTE: Medically acceptable contraceptives include: (1) surgical sterilization, (2) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).

10. Patient, or the patient's legally acceptable representative, must sign and date an informed consent PRIOR to registration and the performance of any study related procedures.

11. Patient, or the patient's legally acceptable representative, must provide written authorization to allow the use and disclosure of their protected health information.

• NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration.

12. If patient is a cancer survivor, all of the following criteria must be met and documented in the patient's medical record:

1. Patient has undergone potentially curative therapy for all prior malignancies.

2. No evidence of prior malignancies for at least 5 years (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or nonmelanoma skin cancer).

3. No evidence of recurrence of any prior malignancy.

Exclusion Criteria:

1. Patient has pancreaticoduodenectomy histopathology of adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma.

2. Patient is pregnant or lactating.

3. Patient has recurrent pancreatic cancer.

4. Patient has received prior systemic chemotherapy or radiotherapy for pancreatic cancer.

5. Patient has received external beam photon (x-ray) therapy to the chest, abdomen or pelvis.

6. Patient has received any biologic/ immunologic therapies.

7. Patient has received chronic immunotherapy (e.g. prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality.

8. Patient has a preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorders.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• interferon-alfa-2b
IV

Drug:
• cisplatin
IV
• 5-fluorouracil
IV

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Rush University Medical Center	Chicago	Illinois
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	Baylor University Medical Center - Houston	Houston	Texas
United States	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Fairview University Medical Center - University Campus	Minneapolis	Minnesota
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Picozzi VJ, Abrams RA, Decker PA, Traverso W, O'Reilly EM, Greeno E, Martin RC, Wilfong LS, Rothenberg ML, Posner MC, Pisters PW; American College of Surgeons Oncology Group.. Multicenter phase II trial of adjuvant therapy for resected pancreatic cancer u — View Citation

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] America

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival at 18 months		at 18 months	No
Secondary	Toxicity		at 18 months	Yes
Secondary	Disease-free survival		at 18 months	No
Secondary	Local-regional disease control		at 18 months	No
Secondary	Distant disease control		at 18 months	No