Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer

This study is currently recruiting participants.
Verified January 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Jill Lacy, Yale University
ClinicalTrials.gov Identifier:
NCT01523457
First received: January 23, 2012
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

The primary objective of this study is to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX). Secondary endpoints include: determine objective response rate according to RECIST; determine overall survival; evaluate toxicity; determine rate of resection in locally advanced unresectable stratum; correlate time to progression, objective response, and overall survival with early changes in glucose metabolism using [18F]-fluorodeoxyglucose (FDG)-positron emission tomography (PET) scanning.


Condition Intervention Phase
Metastatic Pancreatic Cancer
Pancreatic Cancer
Drug: Folfirinox
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The primary objective of this study is to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of FOLFIRINOX.


Secondary Outcome Measures:
  • Objective response rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) at 8 week intervals in patients with metastatic disease and in patients with locally advanced disease.

  • Overall survival [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Overall survival will be determined in patients with metastatic disease and in patients with locally advanced disease.

  • Toxicity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0. Rates of grade 3 and 4 toxicities will be compared to historical controls (Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011;364:1817-25.)

  • Rate of resection in patients with locally advanced unresectable disease [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The rate of surgical resection in the cohort of patients with locally advanced unresectable disease will be determined.

  • Correlate time to progression, objective response, and overall survival with early changes in glucose metabolism using FDG-positron emission tomography (PET) scanning [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The time to progression, objective response rate, and overall survival will be correlated with early changes in glucose metabolism using FDG-positron emission tomography (PET) scanning in patients with metastatic disease and locally advanced disease.


Estimated Enrollment: 67
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: modified FOLFIRINOX Drug: Folfirinox
  • Oxaliplatin 85 mg/m2 IV infused over two hours, followed by
  • Leucovorin 400 mg/m2 IV over two hours
  • Irinotecan 135 mg/m2 IV over 90 minutes (concurrent with leucovorin during the last 90 min of the leucovorin infusion)
  • 5-FU 300mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46 hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologic or cytologic documentation of pancreatic adenocarcinoma
  • Metastatic or locally advanced unresectable disease, including borderline unresectable disease
  • Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemoradiation
  • Measurable or non-measurable assessable disease
  • No prior treatment (chemotherapy, biological therapy, or radiotherapy) for metastatic or non-metastatic locally advanced unresectable pancreatic cancer
  • 6 months since completion of any prior neoadjuvant or adjuvant therapy (chemotherapy or radiotherapy) for resected pancreatic cancer
  • No prior treatment with oxaliplatin or irinotecan
  • No prior treatment with fluoruouracil or capecitabine unless administered as a radiosensitizing drug during adjuvant/neoadjuvant chemoradiotherapy after/before resection of pancreatic cancer
  • Patients who received chemotherapy > 2 years ago for malignancies other than pancreatic cancer are eligible, provided that chemotherapy was completed > 2 years ago and there is no evidence of the second malignancy at the time of study entry
  • > 4 weeks since major surgery
  • No other concurrent anticancer therapy
  • ECOG Performance Status: 0-1
  • Age > 18
  • No other malignancy within past two years except basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer
  • Paraffin block or slides must be available
  • Adequate organ function
  • No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • No > grade 1 sensory peripheral neuropathy
  • No uncontrolled seizure disorder, active neurological disease, or known CNS disease
  • No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
  • No history of chronic diarrhea
  • Not pregnant and not nursing
  • No other medical condition or reason that, in the opinion of the investigator, would preclude study participation
  • Laboratory parameters as follows: absolute neutrophil count ≥ 1,500/uL, platelet count ≥ 100,000/uL, hemoglobin ≥ 9 g,/dL, creatinine < 1.5 X ULN or estimated GFR > 30 ml/min, bilirubin < 1.5 X ULN, AST and ALT < 3 X ULN, negative pregnancy test in women of childbearing age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523457

Contacts
Contact: Jill Lacy, MD 203.737-1600 jill.lacy@yale.edu
Contact: Stacey Stein, MD 203-737-5312

Locations
United States, Connecticut
Smilow Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Jill Lacy, MD         
Sub-Investigator: Stacey Stein, MD         
Sub-Investigator: Howard S Hochster, MD         
Sub-Investigator: Krisha Gunturu, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Jill Lacy, MD Yale University
  More Information

No publications provided

Responsible Party: Jill Lacy, Principle Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01523457     History of Changes
Other Study ID Numbers: 1108008901
Study First Received: January 23, 2012
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
metastatic pancreatic cancer
locally advanced pancreatic cancer
FOLFIRINOX
phase II
progression free survival

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014