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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.


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Adenocarcinoma of Pancreas

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Shubham Pant, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma

Authority:

United States: Institutional Review Board

Study ID:

FOLFIRINOX

NCT ID:

NCT01359007

Start Date:

June 2011

Completion Date:

May 2013

Related Keywords:

  • Adenocarcinoma of Pancreas
  • Locally advanced unresectable adenocarcinoma of pancreas
  • Borderline resectable adenocarcinoma of pancreas
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

Name

Location

University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104