Gemcitabine Hydrochloride, and Radiation Therapy in Patients With Borderline Resectable Pancreatic Cancer
Condition: Pancreatic Adenocarcinoma; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer; Stage III Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Intervention: Fluorouracil; Gemcitabine Hydrochloride; Intensity-Modulated Radiation Therapy; Irinotecan Hydrochloride; Leucovorin Calcium; Oxaliplatin
Intervention description: Given IV; Given IV; Undergo IMRT; Given IV; Given IV; Given IV
Intervention MeSH terms: Calcium, Dietary; Leucovorin; Folic Acid; Gemcitabine; Fluorouracil; Oxaliplatin; Irinotecan; Camptothecin; Calcium; Levoleucovorin
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

Summary:

      This phase II trial studies how well combination chemotherapy, gemcitabine hydrochloride, and
      radiation therapy before surgery works in treating patients with pancreatic cancer that has
      not spread to other places in the body and can be removed by surgery. Drugs used in
      chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan hydrochloride,
      oxaliplatin, and gemcitabine hydrochloride, work in different ways to stop the growth of
      cancer cells, either by killing the cells or by stopping them from dividing. Fluorouracil,
      irinotecan hydrochloride, and gemcitabine hydrochloride may also stop the growth of tumor
      cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy
      and gemcitabine hydrochloride with radiation therapy before surgery may make the tumor
      smaller and reduce the amount of normal tissue that needs to be removed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas

          -  Only patients that have not received any prior treatment for pancreas cancer are
             eligible for this treatment protocol

          -  Patients are not required to have measurable disease by traditional Response
             Evaluation Criteria in Solid Tumors (RECIST) criteria, as lesions in the pancreas are
             notoriously hard to measure radiographically; however, patients must have disease
             which is evaluable for resection

          -  Disease should be determined as "borderline resectable" according to the Expert
             Consensus Statement published by Callery et al:

               -  No distant metastasis

               -  Venous involvement of the superior mesenteric vein (SMV)/portal vein
                  demonstrating tumor abutment with or without impingement and narrowing of the
                  lumen, encasement of the SMV/portal vein but without encasement of the nearby
                  arteries, or short segment venous occlusion resulting from either tumor thrombus
                  or encasement but with suitable vessel proximal and distal to the area of vessel
                  involvement, allowing for safe resection and reconstruction

               -  Gastroduodenal artery encasement up to the hepatic artery with either short
                  segment encasement or direct abutment of the hepatic artery, without extension to
                  the celiac axis

               -  Tumor abutment of the superior mesenteric artery (SMA) not to exceed greater than
                  180 degrees of the circumference of the vessel wall

          -  Life expectancy of greater than 6 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)

          -  Leukocytes >= 3,000/microliter (mcL)

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin =< 2 mg/dl

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 2.5 X institutional upper limit of normal

          -  Creatinine within normal institutional limits OR creatinine clearance >= 60
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Patients may not be receiving any other concurrent chemotherapy, immunotherapy, or
             radiotherapy

        Exclusion Criteria:

          -  Patients who have had prior chemotherapy or radiotherapy for the treatment of pancreas
             cancer

          -  Patients may not be receiving any other investigational agents

          -  Evidence of extent of pancreatic cancer beyond that defined as "borderline resectable"
             above (locally advanced or distant disease); peripancreatic lymph node involvement,
             either confirmed or suspected, will not be considered distant disease unless the lymph
             node involvement extends outside of the field of resection

          -  Patients with known brain metastases should be excluded from this clinical trial

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to 5-fluorouracil, oxaliplatin, irinotecan or gemcitabine

          -  Any concurrent active malignancy other than non-melanoma skin cancers or
             carcinoma-in-situ of the cervix; patients with previous malignancies but without
             evidence of disease for > 3 years will be allowed to enter the trial; patients with a
             history of a T1a or b prostate cancer (detected incidentally at transurethral
             resection of the prostate [TURP] and comprising less than 5% of resected tissue) may
             participate if the prostate-specific antigen (PSA) remained within normal limits since
             TURP removal

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated

          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy are ineligible