FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer

NCT01688336 | Terminated Phase 2 Results DMC

• 1 other identifier: LCCC 1105
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This single arm, multi-center phase II clinical trial will assess the safety and efficacy of FOLFIRINOX in the first-line setting in patients with unresectable locally advanced (ULA) and borderline resectable (BR) pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

Pancreatic; Phase II; FOLFIRINOX; Unresectable; Regimen; First-line; Resectable; Borderline; Oxaliplatin; Leucovorin; Irinotecan; 5FU; Lineberger; University of North Carolina

Outcome Measures

Primary Outcomes (1)

• Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer

  All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).

  Up to 3 years

Secondary Outcomes (5)

• Overall Survival for Borderline Resectable Patients

  Up to 3 years

• Progression Free Survival (PFS)

  the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

• Objective Response Rate

  Up to 3 years

• Disease Control Rate (DCR)

  Up to 3 years

• Rate of Resectability (RR)

  Up to 3 years

Other Outcomes (1)

• Correlation of Tumor Markers (Ca19-9, CEA) With Outcomes (RR, DCR, PFS, and OS).

  Up to 3 years

Study Arms (1)

FOLFIRINOX

EXPERIMENTAL

FOLFIRINOX given to all subjects

Drug: FOLFIRINOX

Interventions

FOLFIRINOX DRUG

FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order: * Oxaliplatin (85 mg/m2) * Leucovorin (400mg/ m2) * Irinotecan (180 mg/m2) * 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours

Also known as: FOLFIRINOX is a chemotherapy regimen comprised of the following drugs, given in combination, -Oxaliplatin, -Leucovorin, -Irinotecan, -5FU

FOLFIRINOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy confirmed adenocarcinoma of the pancreas.
• Measurable or non-measurable but evaluable (as determined by Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\]) unresectable locally advanced (ULA) or borderline resectable (BR) disease that is not amenable to curative intent therapy. Baseline CT abdomen and chest (or MRI abdomen) within 28 days prior to initiation of FOLFIRINOX is required.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• No prior chemotherapy or chemoradiotherapy for pancreatic cancer.
• Age ≥ 18 years of age.
• Laboratory requirements at study entry:
• Hemoglobin ≥ 10 g/dL (transfusions are acceptable)
• absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelets ≥ 100 x 109/L
• Creatinine ≤ 1.5 x upper limit of normal (ULN), or creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)
• Total bilirubin ≤ 1.5 x ULN
• aspartate aminotransferase/Alanine Aminotransferase (AST/ALT) ≤ 3 x ULN
• Gamma-Glutamyl Transferase (GGT) ≤ 5 x ULN
• Life expectancy of at least 6 months.
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test performed within 14 days prior to initiation of FOLFIRINOX.

You may not qualify if:

• Local recurrence or resectable recurrence of pancreatic cancer.
• Other malignancies within the past 3 years except for adequately treated cervical or vulvar carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \>3 years prior to entry is permitted.
• Hypersensitivity to 5FU, oxaliplatin or other platinum agent, or irinotecan or to their excipients. Known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment. Patients are not permitted to participate in another investigational drug study while being treated on this protocol.
• Cardiac disease: Congestive heart failure symptoms \> class II New York Heart Association (NYHA). Unstable angina (anginal symptoms at rest) or new onset angina beginning within the last 3 months. Myocardial infarction within the past 6 months. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• History of or suspected Gilbert's Disease (baseline testing not required).
• Baseline peripheral neuropathy/paresthesia grade ≥ 1.
• Active hepatitis B, unless patient has been on stable meds for at least 2 months (baseline testing not required).
• Active clinically serious infections (\> grade 2).
• Any other hemorrhage/bleeding event \> CTCAE Grade 3 within the 12 weeks prior to the first dose FOLFIRINOX.
• Evidence or history of bleeding diathesis or coagulopathy. Note: If therapeutic anticoagulation required, the investigator is encouraged to switch patient to (or maintain on) low molecular weight heparin during the trial.
• Major surgery, open biopsy or significant traumatic injury within 8 weeks of first study drug. A core pancreatic or liver biopsy does not preclude the patient from the study.
• Unable or unwilling to discontinue use of ketoconazole or St John's wort. Use of CYP3A4 enzyme-inducing drugs and strong CYP3A4 inhibitors is discouraged, but not contraindicated.
• Active drug or alcohol abuse.
• Pregnant or lactating women.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center homepage
• National Cancer Institute (NCI) homepage

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox; Oxaliplatin; Leucovorin; Irinotecan; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• Autumn J McRee, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: September 19, 2012
• Study Start: January 1, 2012
• Primary Completion: August 22, 2016
• Study Completion: November 22, 2016
• Last Updated: October 6, 2017
• Results First Posted: August 21, 2017

Record last verified: 2017-09

Locations

US (1)