Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer


Metastatic Pancreatic Cancer | Pancreatic Cancer

Trial Phase

Phase 2

Trial Purpose and Description

Trial 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.

Participation Guidelines

18 Years - N/A

Eligibility 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

- 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
Yale University
October 2011
Last Updated:
May 19, 2014
Study HIC#:

Clinicaltrials.gov ID: NCT01523457