Clinical trial NCT01523457: Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer
Official title: Phase II Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Pancreatic Cancer
Keywords: metastatic pancreatic cancer
locally advanced pancreatic cancer
FOLFIRINOX
phase II
progression free survival
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was 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 included: 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.

Detailed description: A phase II open label single arm multi-institutional study at Yale's Smilow Cancer Hospital (New Haven, CT, USA), the Smilow Cancer Hospital Care Centers (regional community-based clinics), the VA Connecticut Healthcare System West Haven Campus (West Haven, CT, USA) and Bridgeport Hospital (Bridgeport, CT, USA). The primary objective of this study was to determine the PFS in patients with MPC and LAPC treated with a dose attenuated modification of FOLFIRINOX.

NOTE: Upon results reporting (2016), the registration record was reorganized to display MPC and LAPC groups in individual arms. The most meaningful comparison is between MPC/LAPC and historical controls. That is how results are reported in the published paper, see citations.

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 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 24 weeks
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 24 weeks
measure: Overall Survival
timeFrame: 24 weeks
measure: Toxicity
timeFrame: 24 weeks
measure: Rate of Resection in Patients With Locally Advanced Disease
timeFrame: 24 weeks
measure: Correlate Time to Progression, Objective Response, and Overall Survival With Early Changes in Glucose Metabolism Using FDG-positron Emission Tomography (PET) Scanning
timeFrame: 24 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Smilow Cancer Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Jill Lacy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stein SM, James ES, Deng Y, Cong X, Kortmansky JS, Li J, Staugaard C, Indukala D, Boustani AM, Patel V, Cha CH, Salem RR, Chang B, Hochster HS, Lacy J. Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer. Br J Cancer. 2016 Mar 29;114(7):737-43. doi: 10.1038/bjc.2016.45.