Neoadjuvant Folfirinox Followed by Capecitabine and Limited Field Radiation for Localized Pancreatic Head Adenocarcinoma

NCT01677988 | Terminated Phase 2 Results DMC

• 1 other identifier: 101822
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research study is to determine the safety and effectiveness of modified Folfirinox and radiation therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening tests will be done to determine if subjects are eligible for participation in this study. If subjects are eligible to participate and agree to participate they will begin chemotherapy. After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of completing radiation therapy, subjects will have surgery. There will also be post-treatment and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after their initial registration.

Conditions

Adenocarcinoma of Head of Pancreas

Keywords

NEOADJUVANT FOLFIRINOX CHEMOTHERAPY; LOCALIZED PANCREATIC HEAD ADENOCARCINOMA; RADIATION THERAPY

Outcome Measures

Primary Outcomes (1)

• Estimate the R0/R1 Resection Rate

  Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor.

  at time of surgery

Secondary Outcomes (4)

• Radiographic Tumor Response

  From enrollment to Surgery

• Histopathologic Tumor Response

  at the time of surgery

• Time to Recurrence:

  2 years

• Overall Survival:

  2 years

Other Outcomes (3)

• Feasibility Objective

  From enrollment to end of chemotherapy part of the study

• CTC Analysis

  End of study

• CTC Expression

  2 years

Study Arms (1)

Chemotherapy, Chemoradiation, Surgery

EXPERIMENTAL

Neoadjuvant Chemotherapy- Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles for 3 cycles with growth factor support Chemoradiation Surgical Resection

Drug: Neo-adjuvant Chemotherapy; Radiation: Chemoradiation; Procedure: Surgical Resection

Interventions

Neo-adjuvant Chemotherapy DRUG

1. Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles, for three (3) cycles with growth factor support. 2. Restaging # 1. (CT or MRI; use same modality as baseline staging unless otherwise indicated by Study Team) 1. Progressive Disease (PD) → Off study. Subsequent treatment per patient's primary MD. 2. Stable Disease (SD) or Tumor Response → Continue to Registration #2 for Chemoradiation.

Also known as: FOLFIRINOX chemotherapy

Chemotherapy, Chemoradiation, Surgery

Chemoradiation RADIATION

1. Chemoradiation may be administered at selected approved CTN sites. 2. Determination of resectability as reviewed and documented by MUSC-HCC GI Tumor Board. 1. Unresectable → Off study. Subsequent treatment per patient's primary MD. 2. Resectable → Continue to Registration #3 for Surgical Resection

Chemotherapy, Chemoradiation, Surgery

Surgical Resection PROCEDURE

1. Meets criteria for resectable\* →pancreaticoduodenectomy (POD) 2. At time of resection, snap frozen tumor specimen sent for correlative biomarker studies

Chemotherapy, Chemoradiation, Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has histologically or cytologically confirmed borderline resectable adenocarcinoma of the pancreas. Patients with islet cell or other neuroendocrine neoplasms are excluded.
• Borderline resectable disease as outlined in the protocol
• ≥ 18 years of age.
• Male or non-pregnant and non-lactating female. If a female patient is of childbearing potential, she must have a negative serum pregnancy test (β hCG) documented within 72 hours of the first administration of study drug.
• If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator.
• Patient must not have received prior chemotherapy or radiation for pancreatic cancer and no exposure to systemic chemotherapy.
• Patient have acceptable blood counts, chemistries \& coagulation at baseline as outlined in the protocol
• Patient has an ECOG performance status PS 0-1.
• Patient has been informed about the nature of the study and has agreed to participate in the study and signed the Informed Consent Form prior to participation in any study-related activities.
• Endoscopic ultrasound (EUS) with FNA for cytology.
• Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics.

You may not qualify if:

• Patient has localized resectable, locally advanced unresectable or advanced metastatic disease. Patients with adenocarcinoma of the pancreatic body or tail are ineligible.
• Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
• Patient has known infection with HIV.
• Patient has undergone major surgery, other than diagnostic surgery (i.e.surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
• Prior chemotherapy, immunotherapy or radiation for pancreatic cancer.
• Patient has a history of allergy or hypersensitivity to the study drugs.
• Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapy.
• Patients must not require chronic use of immunosuppressive agents (e.g. methotrexate, cyclosporine).
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years.
• Patients must not have clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) \< 1 year before randomization.
• Patients must not have a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.
• Patient is unwilling or unable to comply with study procedures.
• Patient is enrolled in any other therapeutic clinical protocol or investigational trial.
• Patients aged \> 70

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Results Point of Contact

• Title: Paul O'Brien, MD
• Organization: Medical University of South Carolina

obrienpe@musc.edu

843-792-4271

Study Officials

• Paul E. O'Brien, MD

  Medical University of South 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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: September 3, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2015
• Last Updated: January 15, 2016
• Results First Posted: January 15, 2016

Record last verified: 2015-07

Locations

US (1)