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A Phase II Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients With Borderline Resectable Pancreatic Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

A Phase II Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients With Borderline Resectable Pancreatic Cancer


Gemcitabine has been the cornerstone of systemic therapy for pancreas cancer over this past
decade. Recently, a combination of 5-fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX)
was reported to have significant efficacy in advanced pancreatic cancer. Preclinical data
suggests synergy between irinotecan and 5FU as well as between oxaliplatin and 5FU. Results
of a phase II trial in advanced disease were reported in 2005 demonstrating a 26% confirmed
response rate and median overall survival of 10.2 months. A follow-up phase III trial
comparing FOLFIRINOX with gemcitabine for patients <75 years of age with advanced pancreatic
cancer was presented at ASCO 2010 revealing improvement in PFS (6.4 vs 3.3 months, p=<.0001)
and improved disease control rate (CR+PR+SD) (70.2% vs 50.9%, p=.0003). The most notable
result was an impressive improvement in median overall survival with FOLFIRINOX compared to
gemcitabine (11.1vs 6.8 months, p-value = <.0001, HR=.57). The main toxicity was grade 3/4
neutropenia (45.7% vs 18.7%, p=.0001) and increased risk of febrile neutropenia (5.4% vs
0.6%, p=.009)31.


Inclusion Criteria:



- Patients must have cytologic or histologic confirmation of carcinoma arising in the
pancreas.

- Patients must be deemed to have borderline resectable disease with no radiologic
evidence of distant metastatic disease prior to registration.

- Specifically, patients must have at least one designation of borderline resectable
and no designation of unresectable disease.

- Patients must have a life expectancy of at least 12 weeks, a Zubrod performance
status of < 1 and be willing and medically able to undergo surgical resection.

- Patients must have adequate organ function defined as follows: absolute neutrophil
count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin <
2.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary
stent).

- Patients must be free of other active systemic malignancy, ongoing infection, or any
other serious uncontrolled, concomitant systemic disorders or psychiatric condition
that would interfere with the safe delivery of protocol therapy.

- Patients of reproductive potential must agree to use an effective contraceptive
method during participation in this trial due to the unacceptable teratogenic
toxicity of abdominal radiation and cytotoxic chemotherapy.

- Patients must be aware of the investigational nature of the therapy and provide
written informed consent.

Exclusion Criteria:

- Patients with neuroendocrine tumors are excluded.

- Active systemic malignancy, ongoing infection, or any other serious uncontrolled,
concomitant systemic disorders or psychiatric condition that would interfere with the
safe delivery of protocol therapy.

- Patients with preexisting peripheral neuropathy > grade 2 are ineligible

- Pregnant or nursing women are ineligible.

- Patients must have no history of previous chemotherapy for pancreatic cancer or any
abdominal radiation therapy.

- Patients may not have used any investigational agent within 4 weeks prior to
enrollment into the study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Resection

Outcome Description:

To determine the frequency of achieving an R0 resection using a neoadjuvant regimen of FOLFIRINOX followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine in patients with borderline resectable pancreatic cancer.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Mark Zalupski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

UMCC 2011.007

NCT ID:

NCT01661088

Start Date:

June 2011

Completion Date:

June 2017

Related Keywords:

  • Pancreatic Cancer
  • Neoadjuvant FOLFIRINOX
  • FDR-Gemcitabine
  • Concurrent
  • IMRT
  • Borderline Resectable Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752