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Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer
This study is currently recruiting participants.
Verified by New York University School of Medicine, May 2008
Sponsors and Collaborators: New York University School of Medicine
Sanofi-Aventis
Information provided by: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00463840
  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, Fluorouracil, Radiation
Phase I
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Fluorouracil Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer

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

Primary Outcome Measures:
  • Maximum tolerated dose
  • Toxicity profile for the combination treatment

Secondary Outcome Measures:
  • Time to Progression
  • Overall Survival
  • Tolerance and safety

Estimated Enrollment: 24
Study Start Date: June 2004
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 objective 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:

Inclusion:

  1. Pathologically documented pancreatic adenocarcinoma deemed unresectable due to local involvement of vessels or organs
  2. No prior chemotherapy or Radiation therapy
  3. ECOG Performance Status 0-1
  4. Clinically measurable or evaluable disease
  5. Life expectancy of at least 12 weeks
  6. Granulocyte count > 1500/uL
  7. Platelet count > 100,000/uL
  8. Hemoglobin > 9 g/dL
  9. Adequate renal function with creatinine < 1.5 times ULN
  10. Adequate biliary function with bilirubin < 3.0 g/dL (including patients who have been bypassed or treated with percutaneous drainage)
  11. SGPT (ALT) < 2.5
  12. Age > 18 years

Exclusion Criteria:

  1. Known allergy to one of the study drugs
  2. Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy and women who are pregnant and breastfeeding
  3. Prior malignancy
  4. CNS metastases
  5. Peripheral neuropathy > grade2
  6. Serious concomitant systemic disorder or illness
  7. Active infection or uncontrolled infection
  8. Presence of metastatic disease
  9. Inadequate organ function as discussed above
  10. Use of any investigational agent within a month of treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463840

Locations
United States, New York
NYU Cancer Institute Recruiting
New York, New York, United States, 10016
Contact: Hyemin Choi, RN     212-263-5403     hyemin.choi@nyumc.org    
Principal Investigator: Theresa Ryan, MD            
Sponsors and Collaborators
New York University School of Medicine
Sanofi-Aventis
Investigators
Principal Investigator: Theresa Ryan, MD New York University School of Medicine
  More Information

Responsible Party: New York University School of Medicine ( Theresa Ryan )
Study ID Numbers: 03-64, H11640
Study First Received: April 18, 2007
Last Updated: May 21, 2008
ClinicalTrials.gov Identifier: NCT00463840  
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Locally advanced pancreatic cancer

Study placed in the following topic categories:
Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Fluorouracil
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009