A Phase II Study of Interferon-Based Chemoradiation in Patients With Resected Pancreatic Adenocarcinoma
18 Years
N/A
Both
Pancreatic Cancer
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 |
