FOLFIRINOX in Patients With Inoperable Pancreatic Cancer

This study has been terminated.
(The principal investigator elected to terminate the study due to inactivity and low enrollment)
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01359007
First received: May 23, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of Pancreas
Drug: Irinotecan, Oxaliplatin, Leucovorin, 5-FU
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • To estimate, among patients with locally advanced unresectable and borderline resectable pancreatic cancer, the proportion in whom R0 resection is achieved after neoadjuvant therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients whose pancreatic cancer is operable (resulting in R0 or R1 resection) following induction therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Response rate (either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 criteria) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 4. Toxicity (proportion of patients in whom any grade adverse events are observed) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: June 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOLFIRINOX
Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359007

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Shubham Pant, MD University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01359007     History of Changes
Other Study ID Numbers: FOLFIRINOX
Study First Received: May 23, 2011
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Locally advanced unresectable adenocarcinoma of pancreas
Borderline resectable adenocarcinoma of pancreas

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Oxaliplatin
Irinotecan
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 28, 2014