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Home > "A" Clinical Trials Conditions > Adjuvant Chemoradiotherapy and Interferon alfa in Treating Patients With Resected Pancreatic Cancer  Adjuvant Chemoradiotherapy and Interferon alfa in Treating Patients With Resected Pancreatic Cancer
Adjuvant Chemoradiotherapy and Interferon alfa in Treating Patients With Resected Pancreatic Cancer
For Condition: stage 1 pancreatic cancer,adenocarcinoma of the pancreas,stage 2 pancreatic cancer
Status: Recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, use 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 adjuvantchemoradiotherapy and interferon alfa in treating patients who have resectedstage I or stage II pancreatic cancer.
Details: 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 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the head of the pancreas - Stage I or II (T1-3, 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
VincentPicozzi, Study Chair, Cancer Institute at Virginia Mason Medical Center
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting David Rothenberger 612-626-6122
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting William Burak 614-293-8550
Rush-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612-3833
United States
Recruiting Jules Harris 312-942-3322
Presbyterian Hospital of Dallas *Recruiting*
Dallas, Texas, 75231
United States
Recruiting Archana Ganaraj 214-345-8382
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Murray Brennan 212-639-8691
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-100277
United States
Recruiting Robert W. Marsh 352-392-0058
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting John Cameron 410-955-5166
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center *Recruiting*
Savannah, Georgia, 31403-3089
United States
Recruiting Steven Brower 912-350-7412
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting David Johnstone 585-275-1509
Cancer Institute at Virginia Mason Medical Center *Recruiting*
Seattle, Washington, 98111
United States
Recruiting Richard Thirlby 206-223-6636
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York, 14263-0001
United States
Recruiting William Kraybill 716-845-3284
Additional Information:
Study ID Numbers: CDR0000298776; ACOSOG-Z05031
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059826
Other Adenocarcinoma Of The Pancreas Studies:
1. Gemcitabine and Radiation Therapy Compared With Observation in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
2. Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas
3. Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
4. Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
5. Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer
Related Studies:
Other adenocarcinoma of the pancreas Clinical Trials
Other Florida Clinical Trials
Other Gainesville Clinical Trials
Adjuvant Chemoradiotherapy and Interferon alfa in Treating Patients With Resected Pancreatic Cancer
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