FOLFIRINOX in Patients With Inoperable Pancreatic Cancer

Adenocarcinoma of Pancreas Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01359007
• Other study ID #: 1977
• Status: Terminated
• Phase: Phase 2
• First received: May 23, 2011
• Last updated: February 23, 2018
• Start date: May 2011
• Est. completion date: October 2013

Study information

• Verified date: February 2018
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Pancreas
• Pancreatic Neoplasms

Intervention

Drug:
• Irinotecan, Oxaliplatin, Leucovorin, 5-FU
5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.		2 years
Secondary	Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.		2 years
Secondary	Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)		2 years
Secondary	Overall Survival		2 years
Secondary	Number of Participants Who Experienced Toxicity		2 years