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

NCT00463840 | Terminated Phase 1 Results DMC

• 3 other identifiers: 03-64H11640Sanofi-Aventis 0x 03-030
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pancreatic Cancer

Keywords

Locally advanced pancreatic cancer; oxaliplatin; chemoradiation; 5FU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Median Overall Survival

  up to 10 years since the start of the study

Study Arms (1)

Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6

EXPERIMENTAL

Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal; Combined with : 5FU 200 mg/m\^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m\^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m\^2 Oxaliplatin were tested). Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable. Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle): Day 1 hour 0: Oxaliplatin 85 mg/m\^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m\^2 IV bolus followed by 2400 mg/m\^2 IV over 46 hours.

Drug: Oxaliplatin; Drug: 5FU; Radiation: Radiation; Procedure: Surgery; Drug: FOLFOX 6

Interventions

Oxaliplatin DRUG

Also known as: Oxaliplatin: Eloxatin

Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6

5FU DRUG

Also known as: 5-Fluorouracil

Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6

Radiation RADIATION

Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6

Surgery PROCEDURE

Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6

FOLFOX 6 DRUG

this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin

Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Sanofi: collaborator

Study Sites (2)

Bellevue Hospital

New York, New York, 10016, United States

Location

NYU Cancer Institute

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin; Fluorouracil; Radiation; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Physical Phenomena

Limitations and Caveats

This study did not reach its target accrual due to slow accrual. Small number of patients were analyzed.

Results Point of Contact

• Title: Theresa Ryan, MD
• Organization: New York University Cancer Institute

theresa.ryan@nyumc.org

212-731-5430

Study Officials

• Theresa Ryan, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 20, 2007
• Study Start: June 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2015
• Last Updated: December 5, 2017
• Results First Posted: May 1, 2012

Record last verified: 2017-10

Locations

US (2)