Details

Details

Title A Randomized Phase II Study of Perioperative mFolfirinox Versus Gemcitabine/Nab-Paclitaxel as Therapy for resectable Pancreatic Adenocarcinoma

IRB S1505

CC 15-1472

Hospital Fairview, Hillcrest, Independence, Main Campus, Mansfield, North Coast Cancer, South Pointe, Strongsville, Wooster

Phase Phase 2

Disease Pancreas

Drug Folfirinox, Gemcitabine , Nab-Paclitaxel

Description

Description

Primary Objectives
  • To assess 2-year overall survival in each treatment arm (mFOLFIRINOX and gemcitabine/nab-paclitaxel) in patients with resectable pancreatic cancer.
  • If the stated threshold is met in one or both arms: to choose the better regimen with respect to 2-year overall survival.
Secondary Objectives
  • To estimate, for all patients and within treatment arms:
    • Frequency and severity of adverse events associated with chemotherapy in the perioperative setting.
    • Proportion of patients going to surgery for resection after preoperative chemotherapy.
    • Proportion of patients achieving R0 resection after preoperative chemotherapy.
    • Overall response rate following preoperative chemotherapy, including confirmed and unconfirmed, complete and partial response, per RECIST 1.1.
    • Pathologic response rates after R0 or R1 resection.
    • Patterns of recurrence (loco-regional, distant) after R0 or R1 resection.
    • Disease-free survival from the time of R0 or R1 resection.
Inclusion Criteria

Inclusion Criteria

Disease Related Criteria

  1. Patients must have histologically or cytologically proven pancreatic adenocarcinoma. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible.
  2. Patients must have measurable disease in the pancreas as defined in Section 10.1. CT scans or 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.
  3. Patients must have resectable primary tumor based on contrast-enhanced CT or MRI (CT or MRI without contrast as part of 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 < 180o 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.
  4. CT scans or MRIs used to assess disease at baseline must be submitted for central review (see Section 15.1).
  5. Patients must have surgical consult to verify patient is a surgical candidate within 21 days prior to registration.

Prior/Concurrent Therapy Criteria

  1. Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer.

Clinical/Laboratory Criteria

  1. Patients must have a Zubrod Performance Status of 0-1 (see Section 10.5).
  2. Patients must be > 18 and < 75 years old.
  3. Patients must have adequate hematologic function as evidenced by all of the following within 14 days prior to registration: ANC > 1,500/mcL; platelets > 100,000/mcL; and hemoglobin > 9 g/dL.
  4. Patients must have adequate hepatic function as evidenced by all of the following within 14 days prior to registration: total bilirubin < 1.5 x Institutional Upper Limit of Normal (IULN); AST and ALT both < 2.5 x IULN; and serum albumin > 3 g/dL.
  5. Patients must have adequate kidney function as evidenced by serum creatinine < IULN within 14 days prior to registration.
  6. 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.
  7. No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease and treatment-free for two years.
  8. Patients must not be pregnant or nursing due to risk of fetal or nursing infant harm. 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 outlined in the protocol, he/she is responsible for beginning contraceptive measures.

Specimen Submission Criteria

  1. Sites must seek additional patient consent for the future use of specimens as described in Section 15.2.

Regulatory Criteria

  1. 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.
  2. As a part of the OPEN registration process (see Section 13.2 for OPEN access instructions) 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.

Exclusion Criteria

Exclusion Criteria

Exclusion Criteria Not Available