Page 12 - Delaware Medical Journal - June 2016
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CANCER CLINICAL TRIAL
NCI PROTOCOL OF THE MONTH
CTSU S1505: A Randomized Phase II Study of Perioperative mFOLFIRINOX versus Gemcitabine/nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma
The objectives of the trial are:
Primary Objective:
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:
1. Frequency and severity of adverse events associated with chemotherapy in the perioperative setting.
2. Proportion of patients going to surgery for resection after preoperative chemotherapy.
3. Proportion of patients achieving R0 resection after preoperative chemotherapy.
4.
response, per RECIST 1.1.
5. Pathologic response rates after R0 or R1 resection.
6. Patterns of recurrence (loco-regional, distant) after R0 or R1 resection.
7. Disease-free survival from the time of R0 or R1 resection.
Eligibilty:
1. Patients must have histologically or cytologically proven pancreatic adenocarcinoma.
2. Patients must have measurable disease in the pancreas. 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 of the chest, abdomen, and pelvis.
4. CT scans or MRIs used to assess disease at baseline must be submitted for central review.
5. Patients must have surgical consult to verify patient is a surgical candidate within 21 days prior to registration.
6. Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy
for pancreatic cancer.
7. Patients must have adequate hematologic, hepatic, and kidney function.
8. 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.
9. 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.
10. Patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective
contraceptive.
11.
Treatment:
Arm 1: mFOLFIRINOX will receive 3 cycles of the following treatment, surgery, and 3 additional cycles of the following treatment
Oxaliplatin 85 mg/m2 IV over 2 hours Days1, 15 Prior to irinotecan
Irinotecan 180 mg/m2 IV over 1.5 hours 1, 15 Following oxaliplatin
5-FU 2,400 mg/m2 IV over 46 hours 1-3, 15-17 Following oxaliplatin and irinotecan
Arm 2: Gemcitabine/nab-Paclitaxel will receive 3 cycles of the following treatment, surgery, and an additional 3 cycles of the following treatments
nab-Paclitaxel 125 mg/m2 IV over 30 min 1, 8, 15 Prior to gemcitabine Gemcitabine 1,000 mg/m2 IV over 30 min 1, 8, 15 Following nab-paclitaxel
The Delaware Cancer Treatment Program (DCTP) provides medical insurance coverage to uninsured Delawareans for the treatment of cancer. Call 302-7441040 for more information.
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
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