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

Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Cancer

Intervention: Oxaliplatin (Drug); 5FU (Drug); Radiation (Radiation); Surgery (Procedure); FOLFOX 6 (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: New York University School of Medicine

Official(s) and/or principal investigator(s):
Theresa Ryan, MD, Principal Investigator, Affiliation: New York University School of Medicine

Summary

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

Clinical Details

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

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

Primary outcome: Resectability After Chemoradiation

Secondary outcome: Median Overall Survival

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Bellevue Hospital, New York, New York 10016, United States

NYU Cancer Institute, New York, New York 10016, United States

Additional Information

Starting date: June 2004
Last updated: March 27, 2015

Page last updated: August 20, 2015

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