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A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Resectability After Chemoradiation

Outcome Description:

This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).

Outcome Time Frame:

7.5 weeks

Safety Issue:


Principal Investigator

Theresa Ryan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

December 2013

Related Keywords:

  • Pancreatic Cancer
  • Locally advanced pancreatic cancer
  • oxaliplatin
  • chemoradiation
  • 5FU
  • Pancreatic Neoplasms



NYU Cancer Institute New York, New York  10016
Bellevue Hospital New York, New York  10016