A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma

February 24, 2021 updated by: Abramson Cancer Center of the University of Pennsylvania
Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial is a randomized Phase II study of FOLFIRINOX versus gemcitabine/abraxane in patients with completely resected pancreatic cancer (Stages I-III). Patients will receive eight weeks of chemotherapy, then 5-FU/radiation, then another 8 weeks.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma.
  • Patients must have had all gross disease resected (R0 or R1 resection, patients who underwent an R2 resection are not eligible).
  • Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer.
  • Age > 18 years.
  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Patients must have normal organ and marrow function measured within 2 weeks, prior to registration as follows:

Absolute Neutrophil Count (ANC) > 1,500/µL Platelets > 100,000/µL Total bilirubin less than 2-fold upper limit of normal (ULN) Aspartate Aminotransferase (AST)/alanine aminotransferase (ALT)<2.5X institutional upper limit of normal Creatinine clearance > 60mL/min for patients with creatinine levels above institutional normal.

  • Patients must be > 4 weeks and < 12 weeks post-surgery at time of study registration.
  • Women of childbearing potential and sexually active males are strongly advised to use appropriate contraceptive measures.
  • Women must not be pregnant or breast-feeding.

Exclusion Criteria:

  • Patients receiving any other investigational agents.
  • Patients with known metastases.
  • Patients with wounds that have not fully healed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1 - FOLFIRINOX

FOLFIRINOX:

Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles over 8 weeks

Chemoradiation:

Radiation to begin no sooner than 28 days from last day of chemotherapy.

On Day 1(+ 2days to accommodate scheduling difficulties):

Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined.

FOLFIRINOX:

Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
Drug: FOLFIRINOX
Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
Radiation: Chemoradiation
EXPERIMENTAL: Arm 2 - Gemcitabine / Abraxane

Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles over 8 weeks

Chemoradiation:

Radiation to begin no sooner than 28 days from last day of chemotherapy. On Day 1 (+ 2days to accommodate scheduling difficulties) Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined.

Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles, if tolerated
Radiation: Chemoradiation
Drug: Gemcitabine
1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15
Other Names:
  • Gemzar
Drug: Abraxane
125 mg/m2 IV over 30 minutes, day 1, 8, 15
Other Names:
  • Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Relapse-free Survival
Time Frame: 20 months
In this small trial we will regard a median progression-free survival of 20 months as indicative of potential therapeutic benefit meriting additional study.
20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2013

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

July 1, 2017

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (ESTIMATE)

April 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 03213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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