Clinical trial NCT02178709: A Phase II Study of Neoadjuvant FOLFIRINOX
Official title: A Phase II Study of Neoadjuvant FOLFIRINOX in Patients With Resectable Pancreatic Ductal Adenocarcinoma With Tissue Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Resectable Pancreatic Ductal Adenocarcinoma
Keywords: Pancreatic
Cancer
Resectable
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the rate of pathologic complete response to neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer using a tissue collection component.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years old at the time of informed consent
2. Able to provide written informed consent and HIPAA authorization
3. ECOG performance status of 0 or 1
4. Patient must be eligible for abdominal surgery
5. Histologically confirmed adenocarcinoma of the pancreas that has been documented to be resectable by standardized radiographic criteria by a pancreatic surgeon
6. Patients must to have tumor tissue collected prior to enrolling on this trial. Up to 10 patients will be accepted with no pre-treatment research tissue collection or tissue collection from an outside institution.

   a.If the tissue is from an outside institution, it must be reviewed at Indiana University Health Pathology Department if a biopsy was performed outside of this institution.
7. Women of childbearing potential definition (WOCBP) must have a negative serum or urine pregnancy test performed within 14 days prior to initiation of FOLFIRINOX.

   Any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) is classified as WOCBP if she meets the following criteria:
   1. Has not undergone a hysterectomy or bilateral oophorectomy; or
   2. Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
8. WOCBP and men must agree to use adequate contraception prior, to study entry, for the duration of study participation, and 8 weeks after the end of treatment.
9. Patients must have adequate organ function as defined by the following laboratory values at study entry:

   1. Hemoglobin ≥ 9 g/dL (transfusions are acceptable)
   2. ANC ≥ 1.5 x 109/L
   3. Platelets ≥ 100 x 109/L
   4. Creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)
   5. Total bilirubin ≤ 1.5 x ULN
   6. AST/ALT ≤ 3 x ULN

Exclusion Criteria:

1. Prior therapy for pancreatic adenocarcinoma
2. Other malignancies within the past 3 years except for the following: adequately treated cervical or vulvar carcinoma in situ, treated basal cell or squamous carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), ductal carcinoma in situ (DCIS) of the breast and low grade prostate cancer. Any cancer curatively treated \>3 years prior to entry with no clinical evidence of recurrence is permitted.
3. Hypersensitivity to 5FU, oxaliplatin (or other platinum agents), irinotecan (or to their excipients).
4. Participation in any investigational drug study within 4 weeks preceding the start of study treatment. Patients are not permitted to participate in another investigational drug study while being treated on this protocol.
5. Inability to receive a port or PICC line.
6. History of or suspected Gilbert's Disease (testing not required if presence is not suspected).
7. Baseline peripheral neuropathy/paresthesia grade ≥ 1.
8. Active hepatitis B, unless patient has been on antiviral agents for at least 2 months (baseline testing not required).
9. Active clinically serious infections (\> grade 2).
10. Major surgery or significant traumatic injury within 8 weeks of first study drug. A core pancreatic or liver biopsy does not preclude the patient from the study.
11. Unable or unwilling to discontinue use of ketoconazole or St John's wort. Use of phenytoin, carbamazepine, phenobarbital, rifampin and rifabutin is discouraged, but not contraindicated. If patients require phenytoin, carbamazepine or phenobarbital monitoring of drug levels is suggested during the study.
12. Pregnant or lactating women.
13. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Primary outcomes:
measure: Percentage of Patients With Pathologic Complete Response
timeFrame: Up to 4 months
Secondary outcomes:
measure: Number of Patients With Treatment-Related Adverse Events Grade 3 or Above
timeFrame: Every 15 days for approximately 6 months
measure: Percentage of Patients Who Successfully Underwent Surgery After Neoadjuvant FOLFIRINOX
timeFrame: Up to 4 months
measure: Rate of R0 Resection
timeFrame: Up to 4 months
measure: Disease Free Survival
timeFrame: Up to 3 years
measure: Overall Survival
timeFrame: Up to 4 years
measure: Objective Response Rate (Percentage of Patients With Complete Response or Partial Response)
timeFrame: Up to 4 months
measure: Disease Control Rate (Percentage of Patients With Complete Response, Partial Response, or Stable Disease)
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Michael House, M.D.
role: PRINCIPAL_INVESTIGATOR
References: