Clinical trial NCT01359007: FOLFIRINOX in Patients With Inoperable Pancreatic Cancer
Official title: A Phase II Study Evaluating the Rate of R0 Resection (Microscopically Negative Margins) After Induction Therapy With 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan (FOLFIRINOX) in Patients With Borderline Resectable or Locally Advanced Inoperable Pancreatic Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Adenocarcinoma of Pancreas
Keywords: Locally advanced unresectable adenocarcinoma of pancreas
Borderline resectable adenocarcinoma of pancreas
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced unresectable or borderline resectable adenocarcinoma of pancreas
* Patients must have measurable disease as defined by RECIST 1.1 RECIST evaluations must have occurred within 4 weeks prior to study entry
* No evidence of hepatic or pulmonary metastatic disease by CT or CT/PET scans
* Male or non-pregnant and non-lactating female age \> or equal to 18 years and \< or equal to 70 years of age
* Patient must have received no prior therapy for the treatment of locally advanced unresectable or borderline resectable pancreatic cancer
* Patients must have adequate blood counts at baseline and blood chemistry levels
* Patient has ECOG Performance Status 0 to 1

Exclusion Criteria:

* Patients with islet cell neoplasms excluded
* Patients with known brain metastases
* Therapeutic Coumadin for a history of pulmonary emboli or deep vein thrombosis (DVT)
* Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
* Known infection with HIV, hepatitis B or hepatitis C
* Major surgery or vascular device placement within 4 weeks prior to Day 1 of treatment in study
* Prior chemotherapy or radiation for pancreatic cancer
* History of allergy or hypersensitivity to the study drugs
* Patient is enrolled in any other clinical protocol or investigational trial
* Metastatic disease on radiological staging
* Prior malignancy within last 3 years
* Significant cardiac disease
* Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation in which in opinion of the investigator may place the patient at increased risk
* peripheral sensory neuropathy \> or equal to grade 2 at baseline

Primary outcomes:
measure: To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.
timeFrame: 2 years
measure: Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
measure: Number of Participants Who Experienced Toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Shubham Pant, MD
role: PRINCIPAL_INVESTIGATOR
References: