A Phase II Study of Neoadjuvant FOLFIRINOX

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT02178709
First received: June 24, 2014
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Resectable Pancreatic Ductal Adenocarcinoma
Drug: FOLFIRINOX
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant FOLFIRINOX in Patients With Resectable Pancreatic Ductal Adenocarcinoma With Tissue Collection

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • The rate of pathologic complete response evaluated by MRI or CT [ Time Frame: After approximately 2 months ] [ Designated as safety issue: No ]
    The primary objective of this study is to evaluate the rate of pathologic complete response to neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer.


Secondary Outcome Measures:
  • Safety of FOLFIRINOX when administered preoperatively determined by toxicity monitoring [ Time Frame: Every 15 days for approximately 24 weeks ] [ Designated as safety issue: Yes ]
    To describe the adverse events associated with FOLFIRINOX when administered preoperatively in patients with resectable pancreatic cancer.

  • Ability of patients who can successfully undergo surgery after chemotherapy determined by toxicity monitoring [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    To estimate the fraction of patients who can successfully undergo surgery after neoadjuvant chemotherapy.

  • To estimate the overall resectability rate after the administration of FOLFIRINOX as determined by toxicity monitoring. [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    3. To estimate the overall resectability rate, rate of R0 resection, disease free survival (DFS), overall survival (OS), overall response rate (ORR; complete response (CR) + partial response (PR)), and disease control rate (DCR; CR + PR + stable disease (SD)) after administration of FOLFIRINOX in patients with resectable pancreatic cancer.


Estimated Enrollment: 48
Study Start Date: June 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOLFIRINOX

FOLFIRINOX consists of the following combination of drugs:

  1. Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle
  2. Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle
  3. Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle
  4. 5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle.
  5. 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle.
Drug: FOLFIRINOX

FOLFIRINOX consists of the following combination of drugs:

  1. Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle
  2. Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle
  3. Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle 4.5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle.

5.5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle.

Other Names:
  • FOLFIRINOX
  • Oxaliplatin (Eloxatin)
  • Leucovorin
  • Irinotecan (Camptosar)
  • 5 FU (Adrucil)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02178709

Contacts
Contact: Safi Shahda, M.D. 317-278-4688 shahdas@iu.edu

Locations
United States, Indiana
Indiana University Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Safi Shahda, M.D.    317-278-4688    shahdas@iu.edu   
Contact: Janet Flynn, R.N.    317-274-0972    janflynn@iupui.edu   
Principal Investigator: Safi Shahda, M.D.         
Sub-Investigator: Janet Flynn, R.N.         
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Safi Shahda, M.D. Indiana University
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT02178709     History of Changes
Other Study ID Numbers: IUCRO-0473
Study First Received: June 24, 2014
Last Updated: June 27, 2014
Health Authority: United States: Indiana University

Keywords provided by Indiana University:
Pancreatic
Cancer
Resectable

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma, Ductal, Breast
Breast Diseases
Breast Neoplasms
Carcinoma
Carcinoma, Ductal
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Skin Diseases
Irinotecan
Oxaliplatin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014