Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01523457
First received: January 23, 2012
Last updated: May 19, 2014
Last verified: May 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
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: NCT01523457

Locations
United States, Connecticut
Smilow Cancer Center
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Jill Lacy, MD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01523457     History of Changes
Other Study ID Numbers: 1108008901
Study First Received: January 23, 2012
Last Updated: May 19, 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 October 01, 2014