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Pancreatic Clinical Trials

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Alliance A021501

Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Physician

    Asim Ali, MD

    Study Coordinator

    Kendra Campbell, MA

    484-526-7952

    Kendra.campbell@sluhn.org
  • Treatment Agent: Xaliplatin, irinotecan, leucovorin, and 5-fluorouracil.

    Synopsis: The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiation prior to surgery. This study will allow the researchers to know whether which approach is better, the same, or worse than the other.

  • Pre-Registration Eligibility Criteria:

    • Documentation of Disease:
      • Pathology: Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process. Diagnosis should be verified by local pathologist.
      • TNM Stage: TX, T1-4N0-1orNxM0*
        • M1 disease includes spread to distant lymph nodes, organs, and ascites
      • Criteria for borderline resectable disease: Local radiographic reading must be consistent with borderline resectable cancer of the pancreatic head as defined by intergroup radiographic criteria and must meet any one or more of the following on CT/MRI:
        • An interface is present between the primary tumor and the superior mesenteric vein or portal vein and measures ≥ 180° of the circumference of the vessel wall
        • Short-segment occlusion of the SMV-PV is present with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction
        • Short segment interface (of any degree) is present between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction
        • An interface is present between the tumor and superior mesenteric artery or celiac axis measuring < 180° of the circumference of the vessel wall
      • Patients with less extensive disease than the above four (4) criteria are considered potentially resectable and are NOT eligible.
      • Patients with more extensive disease than the above 4 criteria are considered locally advanced and are NOT eligible.
      • In addition patients with the following are considered locally advanced and are NOT eligible: Any interface between the tumor and the aorta.
      • See the protocol for additional clarification and definitions of less and more extensive disease.

    Registration Eligibility Criteria:

    • Disease Status - Confirmation of radiographic stage as borderline resectable disease by real-time Alliance central radiographic review
    • Prior Treatment
      • No prior chemotherapy or radiation for pancreatic cancer
      • No definitive resection of pancreatic cancer
    • Concomitant Medications
      • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. See the protocol for more information.
      • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment. See the protocol for more information.
    • Medical History
      • No grade ≥ 2 neuropathy
      • No known Gilbert's Syndrome or known homozygosity for UGAT1A1*28 polymorphism
      • No uncontrolled gastric ulcer disease (Grade 3 gastric ulcer disease) within 28 days of registration
    • Pregnancy and Nursing Status - Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.
    • Age ≥ 18 years
    • ECOG Performance Status 0 or 1
    • Required Initial Laboratory Values:
      • Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
      • Platelet Count ≥ 100,000/mm3
      • Creatinine ≤ 1.5 x upper limit of normal (ULN) or
      • Calc. Creatinine Clearance > 45 mL/min
      • Total Bilirubin ≤ 2.0 mg/dL
      • AST / ALT ≤ 2.5 x ULN

SWOG 1505

A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Kendra Campbell, MA 
    484-526-7952

    Kendra.campbell@sluhn.org
  • Treatment Agent: mFOLFIRINOX, Gemcitabine

    Synopsis: The purpose of this study is to compare the effects of two different combinations of FDA-approved chemotherapy drugs. These two combinations are called mFOLFIRINOX (oxaliplatin, irinotecan, and fluorouracil) and gemcitabine plus nab-paclitaxel. These chemotherapy drugs will be given before and after surgery. The addition of these chemotherapy drugs before surgery is a new approach that is being tested in this study. This new approach could prevent your cancer from returning, but it could also cause side-effects. This study will allow the researchers to know if it is a good idea to treat pancreatic cancer with chemotherapy drugs before surgery, and if so, to see which of the two drug combinations is better. To be better, the study approach should increase the number of people alive at 2 years from about 40% with the usual approach to about 58% with the newer approach. There will be about 112 people taking part in this study.

     

    • Patients must have histologically or cytologically proven pancreatic adenocarcinoma; histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible
    • Patients must have measurable disease in the pancreas; computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess measurable disease must have been completed within 28 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form
    • Patients must have resectable primary tumor based on contrast-enhanced CT or MRI (CT or MRI without contrast as part of positron emission tomography [PET]/CT or PET/MRI is NOT acceptable; CT or MRI with contrast as part of PET/CT or PET/MRI is acceptable) of the chest, abdomen, and pelvis, where resectable is defined as:

      • No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery)
      • No involvement, or < 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein; and patent portal vein/splenic vein confluence
      • No evidence of metastatic disease
      • Note: for tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease
    • CT scans or MRIs used to assess disease at baseline must be submitted for central review
    • Patients must have surgical consult to verify patient is a surgical candidate within 21 days prior to registration
    • Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer
    • Patients must have a Zubrod performance status of 0-1
    • Absolute neutrophil count (ANC) >= 1,500/mcL
    • Platelets >= 100,000/mcL
    • Hemoglobin >= 9 g/dL
    • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN
    • Serum albumin >= 3 g/dL
    • Serum creatinine =< IULN within 14 days prior to registration
    • Patients with 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 will NOT be eligible
    • No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer, in situ breast (ductal or lobular) cancer, or other cancer for which the patient has been disease and treatment-free for two years
    • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method for up to 3 months after the final administered dose of chemotherapy; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he/she is responsible for beginning contraceptive measures
    • Sites must seek additional patient consent for the future use of specimens
    • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
    • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
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