Clinical trial NCT02243007: Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer
Official title: Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Resectable Pancreatic Cancer
Pancreatic Ductal Carcinoma
Keywords: Resectable pancreatic cancer
Pancreatic Ductal Carcinoma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery.

Detailed description: Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B

* Treatment will be administered on an outpatient basis.
* Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
* After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without progressive disease will proceed to radiation therapy with capecitabine .
* Between 2 and 4 weeks after radiation is complete, participants will proceed for surgical resection of pancreatic cancer

Eligibility criteria: Inclusion Criteria:

* Cytologic or histologic proof of pancreatic ductal carcinoma is required prior to study entry.
* No evidence of metastatic disease as determined by chest CT scan, and abdominal CT scan (or MRI with gadolinium and/or manganese) and laparoscopy. All patients must be staged with a physical exam, chest CT, abdominal CT with intravenous contrast (or abdominal MRI with gadolinium and/or manganese). Only potentially resectable patients are eligible. Potentially resectable is defined as a) no extrapancreatic disease, b) no evidence (on CT) of involvement of the celiac axis or SMA, c) no evidence (CT or MRI) of occlusion of the SMV or SMPV confluence, and d) no evidence of gross peritoneal or distant metastases by laparoscopy.
* Patients must be 18 years old or older. There will be no upper age restriction.
* ECOG Performance Status of 0 or 1 are eligible.
* Life expectancy of greater than 3 months.
* Lab Values:

  * ANC ≥ 1500 cells/mm3
  * Platelet count at least 100,000 cells/mm3.
  * AST and ALT ≤2.5 x upper limit of normal
  * Total Bilirubin ≤ 5 x upper limit of normal if patient is s/p biliary stenting AND decreasing at least two time points after stenting.
  * Total Bilirubin ≤ 1.5 x upper limit of normal if no biliary stenting was done
  * Serum Creatinine ≤1.5mg/dl OR
  * Creatinine Clearance greater than or equal to 30ml/min (as estimated by Cockroft Gault Equation) (140 - age \[yrs\]) (body wt \[kg\])

    * Creatinine clearance for males = ------------ (72) (serum creatinine \[mg/dL\])
    * Creatinine clearance for females = 0.85 x male value
* The effects of radiation on the developing human fetus are known to be teratogenic. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment plus 30 days from the last date of study drug administration. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients who fulfill any of the following criteria will be excluded:

* The presence of metastatic disease on imaging or laparoscopy.
* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever.
* Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
* Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
* Diagnosis for other invasive carcinomas (except basal cell carcinoma/squamous cell carcinoma of the skin) within the last five years. Carcinoma in-situ is allowed.
* Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
* Unwillingness to participate or inability to comply with the protocol for the duration of the study.
* Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
* History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance or oral drug intake.
* Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery.

Primary outcomes:
measure: Survival Rate at 18 Month
timeFrame: 18 Month
Secondary outcomes:
measure: Pathologic Complete Response Rate (pCR).
timeFrame: 18 Months
measure: Overall Survival Rate
timeFrame: Baseline, 5 Years
measure: Number of Participants With Serious and Non-Serious Adverse Events
timeFrame: Baseline, 28 Days
measure: Surgical Morbidity Rate
timeFrame: within 30 days of surgery
measure: 30-day Post-operative Mortality Rate
timeFrame: 30 Days
measure: Correlation of Biomarkers With PFS
timeFrame: 2 Years
measure: Rate of Pathologic Downstaging
timeFrame: 2 Years
measure: Local Control Rate
timeFrame: 2 Years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David Ryan, MD
role: PRINCIPAL_INVESTIGATOR
References: