Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00463840
First received: April 18, 2007
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.


Condition Intervention Phase
Pancreatic Cancer
Drug: Oxaliplatin
Drug: 5FU
Radiation: Radiation
Procedure: Surgery
Drug: FOLFOX 6
Phase 1
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 I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Resectability After Chemoradiation [ Time Frame: 7.5 weeks ] [ Designated as safety issue: No ]
    This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).


Secondary Outcome Measures:
  • Median Overall Survival [ Time Frame: up to 10 years since the start of the study ] [ Designated as safety issue: No ]
    This is the time at which 50% of patients are alive from the trial entry .


Enrollment: 24
Study Start Date: June 2004
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6

Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery

Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;

Combined with :

5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).

Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.

Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):

Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours.

Drug: Oxaliplatin
Other Name: Oxaliplatin: Eloxatin
Drug: 5FU
Other Name: 5-Fluorouracil
Radiation: Radiation Procedure: Surgery Drug: FOLFOX 6
this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin

Detailed Description:

Previous studies have demonstrated that neoadjuvant chemoradiation can lead to improved survival with a portion of patients proceeding to resection. This trial will incorporate a similar trial structure using newer agents in patients who present with locally advanced unresectable pancreatic cancer. Specifically oxaliplatin will be used owing to its greater activity in comparison to cisplatin and favorable therapeutic index in combination with radiation compared to gemcitabine.

In summary, the primary outcome measure of the phase I portion of the trial is to determine the maximum tolerated dose of this combination. Following the determination of this dose, the phase II portion of the trial will characterize the toxicity of this regimen as well as evaluate for long-term efficacy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically documented pancreatic adenocarcinoma deemed unresectable due to local involvement of vessels or organs
  • Patients with a clear clinical diagnosis of localized pancreatic cancer deemed unresectable, who have undergone at least 2 biopsies which were not diagnostic of adenocarcinoma, may be entered at the discretion of the principal investigator.
  • No prior chemotherapy or abdominal radiation therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Clinically measurable or evaluable disease.
  • Life expectancy of at least 12 weeks.
  • Adequate bone marrow reserve, granulocyte count >= 1500/uL, platelet count >= 100,000/uL, hemoglobin >= 9 g/dL.
  • Adequate renal function with creatinine =< 1.5 times upper limit of normal (ULN)
  • Adequate biliary function with bilirubin < 3.0 g/dL (including patients who have been bypassed or treated with percutaneous drainage), serum glutamic pyruvic transaminase (SGPT) (alanine transaminase) =< 2.5
  • Age > 18 years
  • Signed informed consent.
  • No known allergy to one of the study drugs
  • For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
  • No prior malignancy within last 5 years
  • No central nervous system metastases
  • No peripheral neuropathy > grade2
  • No other serious concomitant illness

Exclusion Criteria:

  • Active infection or uncontrolled infection
  • Presence of metastatic disease.
  • Inadequate organ function as discussed above.
  • Pregnancy
  • Serious concomitant systemic disorder.
  • Use of any investigational agent within a month of treatment
  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: NCT00463840

Locations
United States, New York
NYU Cancer Institute
New York, New York, United States, 10016
Bellevue Hospital
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Sanofi
Investigators
Principal Investigator: Theresa Ryan, MD New York University School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00463840     History of Changes
Other Study ID Numbers: 03-64, H11640, Sanofi-Aventis 0x 03-030
Study First Received: April 18, 2007
Results First Received: March 5, 2012
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
Locally advanced pancreatic cancer
oxaliplatin
chemoradiation
5FU

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Oxaliplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014