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

Pancreatic Cancer Clinical Trial

Official title:

Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00275119
• Other study ID #: CDR0000454568
• Secondary ID: GERCOR-D03-1EU-2
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 10, 2006
• Last updated: February 6, 2009
• Start date: November 2003

Study information

• Verified date: January 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the pancreas

• Locally advanced, nonresectable disease

• Residual disease after surgical resection (R1, R2) OR recurrent disease after radical surgery

• No visceral or peritoneal metastases

• No adenocarcinoma of the bile ducts or the ampulla of Vater

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Stable or controlled pain with analgesics

• Not pregnant or nursing

• Neutrophil count = 1,500/mm³

• Platelet count = 100,000/mm³

• Creatinine = 1.5 times normal OR < 3 mg/dL

• Creatinine clearance = 40 mL/min

• Bilirubin = 1.5 times normal

• Alkaline phosphatase < 5 times normal

• No medical condition that would preclude study treatment

• No active infection

• Negative pregnancy test

• No serious cardiac or respiratory disease

• No uncontrolled or persistent hypercalcemia

• No pre-existing neuropathy

• No biliary or gastro-duodenal obstruction

• No other malignancy except nonmelanomatous skin cancer, prostate cancer, or carcinoma in situ of the cervix or bladder

• No familial, social, geographical, or psychological condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior abdominal radiotherapy (encompassing the liver, pancreas, or spleen)

• At least 2 months since prior radiotherapy

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• fluorouracil

• gemcitabine hydrochloride

• oxaliplatin

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon
France	Clinique Tivoli	Bordeaux
France	Hopital Saint Andre	Bordeaux
France	Hopital Drevon	Dijon
France	CHU de Grenoble - Hopital de la Tronche	Grenoble
France	Hopital Saint - Louis	La Rochelle
France	Clinique Victor Hugo	Le Mans
France	Clinique Saint Jean	Lyon
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille
France	Hopital Saint Antoine	Paris
France	Hopital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

References & Publications (2)

Moureau-Zabotto L, Phélip J, Afchain P, et al.: Concomitant administration of weekly oxaliplatin, 5FU continuous infusion and radiotherapy in locally advanced pancreatic cancer (LAPC): a Gercor phase II study. [Abstract] Int J Radiat Oncol Biol Phys 66 (3

Moureau-Zabotto L, Phélip JM, Afchain P, Mineur L, André T, Vendrely V, Lledo G, Dupuis O, Huguet F, Touboul E, Balosso J, Louvet C. Concomitant administration of weekly oxaliplatin, fluorouracil continuous infusion, and radiotherapy after 2 months of gem — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival			No
Secondary	Tolerability			Yes
Secondary	Recurrence-free survival			No
Secondary	Overall survival			No
Secondary	Response rate			No
Secondary	Quality of life			No
Secondary	Clinical benefits			No
Secondary	Locoregional and metastatic progression-free survival			No