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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00463840
• Other study ID #: 03-64
• Secondary ID: H11640Sanofi-Ave
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: April 18, 2007
• Last updated: October 30, 2017
• Start date: June 2004
• Est. completion date: October 2015

Study information

• Verified date: October 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: October 2015
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Oxaliplatin

• 5FU

Radiation:
• Radiation

Procedure:
• Surgery

Drug:
• FOLFOX 6
this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin

Locations

Country	Name	City	State
United States	Bellevue Hospital	New York	New York
United States	NYU Cancer Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resectability After Chemoradiation	This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).	7.5 weeks
Secondary	Median Overall Survival	This is the time at which 50% of patients are alive from the trial entry .	up to 10 years since the start of the study