Chemoradiation in Locally Advanced Pancreatic Cancer

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Interferon alfa may interfere with the growth of tumor cells. Giving combination chemotherapy and radiation therapy together with interferon alfa before surgery may shrink the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy and radiation therapy together with interferon alfa works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Cisplatin; Fluorouracil; Interferon alpha-2; Interferon-alfa-1b; Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

• Patient must have newly diagnosed computated tomography (CT) and endoscopic ultrasound(EUS) stage Tx-4, N0-1, M0 adenocarcinoma of pancreas according to the American Joint Committee on Cancer (AJCC) staging system. The following cell types will NOT be eligible: adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma

• Treatment must begin within 60 days of diagnosis

• Must have locally advanced inoperable pancreatic cancer with no metastatic spread as determined by a baseline diagnostic CT scan of the chest, endoscopic ultrasound and CT scan with intravenous (IV) contrast (or MRI) of abdomen/pelvis, within 30 days prior to registration.

• No prior systemic chemotherapy or radiation therapy for pancreatic cancer

• Documented Eastern Cooperative Oncology Group (ECOG/Zubrod) performance status 0-1 within 14 days prior to registration

• Adequate hematologic, renal and hepatic function as defined by the following laboratory values (completed within 14 days prior to registration)

• white blood cell (WBC) > 3,000 mm3

• absolute neutrophil count (ANC) > 1,500 mm3

• platelet count ≥ 100,000 mm3

• hemoglobin > 9.5 g/dl

• serum creatinine < 1.5 times institutional upper limit of normal (ULN)

• total bilirubin ≤ 3 mg/dl

• AST (SGOT) < 4.0 times institutional ULN

• ALT (SGPT) < 4.0 times institutional ULN

• alkaline phosphatase < 2.0 times institutional ULN

• Age ≥ 18 years

• Life expectancy ≥ 12 weeks

• Patient (male or female) of reproductive potential are required to use a medically acceptable contraception during treatment and for 3 months after the last dose of chemotherapy.

• Not pregnant or breastfeeding since the drugs used in this study are Pregnancy Category D: Clear evidence of risk in pregnancy. A negative pregnancy test is required within 7 days of registration if pre- or perimenopausal (i.e., last menstrual period within one year of registration)

• If patient has a previous diagnosis of cancer, all of the following criteria must be met and documented in the patient's medical record:

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

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

• No evidence of recurrence of any prior malignancy.

• Patient who is receiving chronic immunotherapy (e.g. prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality are not eligible.

• Not requiring one or more of the contraindicated medications

• Patient must be able to understand the potential risks and benefits associated with this study. Patient able to give informed consent and would likely to comply with the study parameters.