Clinical trial NCT00463840: Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer
Official title: A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: Locally advanced pancreatic cancer
oxaliplatin
chemoradiation
5FU
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2007-04-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Resectability After Chemoradiation
timeFrame: 7.5 weeks
Secondary outcomes:
measure: Median Overall Survival
timeFrame: up to 10 years since the start of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital
state: New York
city: New York
country: United States
facility: NYU Cancer Institute
state: New York
Study officials:
affiliation: NYU Langone Health
name: Theresa Ryan, MD
role: PRINCIPAL_INVESTIGATOR
References: