Chemoradiation in Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: recombinant interferon alfa; cisplatin; fluorouracil; radiation therapy; Resection of tumor
Intervention description: administered subcutaneously (SQ)at a dose of 3 million units Day 1,3, and 5 each week in Cycle 1; administered at a dose of 30 mg/m2 intravenously (IV) day 1 each week in Cycle 1; administered at a dose of 175 mg/m^2/day continuous infusion (CI) for 38 days in Cycle 1 and then 500 mg/m^2 intravenously (IV) each week for 6 weeks followed by a 2 week rest (1 cycle = 8 weeks)in Cycle 2 and 3; 5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks (days 1-5, 8-12, 15-19, 22-26, 29-33, 36-38).; After Cycle 1 treatment (if resectable)- In the absence of metastatic disease, special emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. Surgical exploration will start with a diagnostic laparoscopy. If no evidence of carcinomatosis, liver metastases or other evidence of metastatic disease is encountered, then a laparotomy will be performed. In the absence of clear technical unresectability, a radical pancreaticoduodenectomy, distal or total pancreatectomy (and resection of any involved structures) will be performed as mandated by tumor anatomy.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Interferon-alfa-1b; Cisplatin; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas

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.
    

Eligibility 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.