Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

Phase 2

• Conditions: Pancreatic Cancer

• Registration Number: NCT00275119
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES:

Primary

* Compare progression-free survival of patients with locally advanced, nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy, fluorouracil, and oxaliplatin.

Secondary

* Determine the tolerability of this regimen, in both the short- and long-term, in these patients.

* Determine recurrence-free survival, overall survival, and response rate in patients treated with this regimen.

* Determine the quality of life of patients treated with this regimen.

* Determine the clinical benefits of this regimen in these patients.

* Determine locoregional and metastatic progression-free survival of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

* Chemotherapy: Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are restaged at day 15-21 of the fourth course of chemotherapy. Patients with nonmetastatic disease proceed to chemoradiotherapy.

* Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29 in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at restaging, and at day 28 after completion of chemoradiotherapy.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Study Timeline

• Study Start: 2003-11
• Status Verified: 2006-01
• Study First Submitted: 2006-01-10
• Study First Submitted QC: 2006-01-10
• Study First Posted: 2006-01-11
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival

Secondary Outcome Measures

Name	Time	Method
Response rate
Quality of life
Recurrence-free survival
Overall survival
Tolerability
Clinical benefits
Locoregional and metastatic progression-free survival

Trial Locations

Locations (11)

Institut Sainte Catherine; 🇫🇷 Avignon, France

CHU de Grenoble - Hopital de la Tronche; 🇫🇷 Grenoble, France

Hopital Saint - Louis; 🇫🇷 La Rochelle, France

Clinique Victor Hugo; 🇫🇷 Le Mans, France

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France

Clinique Saint Jean; 🇫🇷 Lyon, France

Hopital Saint Andre; 🇫🇷 Bordeaux, France

Clinique Tivoli; 🇫🇷 Bordeaux, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Hopital Drevon; 🇫🇷 Dijon, France

Hopital Tenon; 🇫🇷 Paris, France