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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival at 18 months

Safety Issue:

No

Principal Investigator

Vincent J. Picozzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000298776

NCT ID:

NCT00059826

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Rush University Medical Center Chicago, Illinois  60612-3824
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky  40202
Fairview University Medical Center - University Campus Minneapolis, Minnesota  55455
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Baylor University Medical Center - Houston Houston, Texas  77030-2399
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Brigham and Women's Hospital Boston, Massachusetts  02115
Presbyterian Hospital of Dallas Dallas, Texas  75231