Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma - Full Text View

Sponsor:	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075452

Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.

PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: gemcitabine hydrochloride Drug: oxaliplatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Oxaliplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to response [ Designated as safety issue: No ]
Clinical benefit [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]

Study Start Date:

November 2003

Detailed Description:

OBJECTIVES:

Primary

Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin.

Secondary

Compare the time of response in patients treated with these regimens.
Compare the clinical benefit of and tolerance to these regimens in these patients.
Compare the quality of life of patients treated with these regimens.
Compare the progression-free survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity.

After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy.

Quality of life is assessed at baseline and then every 2 months.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed pancreatic adenocarcinoma
- Locally advanced or metastatic disease
- Unresectable disease
Measurable disease
- At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner
No adenocarcinoma of the bile ducts or ampulla of Vater
No known brain metastases

PATIENT CHARACTERISTICS:

Age

18 to 75

Performance status

ECOG 0-2 OR
Karnofsky 60-100%

Life expectancy

More than 12 weeks

Hematopoietic

Absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3

Hepatic

Bilirubin less than 1.5 times normal
Alkaline phosphatase less than 5 times normal

Renal

Creatinine less than 1.5 times normal
No uncontrolled or persistent hypercalcemia

Cardiovascular

No serious cardiac failure

Pulmonary

No serious respiratory failure

Other

Pain must be stabilized or controlled before initiation of study treatment
Not pregnant or nursing
Fertile patients must use effective contraception
No other untreatable malignant tumor
No serious psychological, familial, social, or geographical condition that would preclude study participation
No neuropathy that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

No concurrent corticosteroids except for antiemetic therapy

Radiotherapy

No prior radiotherapy

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075452

Locations

France
American Hospital of Paris
Neuilly Sur Seine, France, F-92202
C. H. De Saumur
Saumur, France, 49403
C. H. Du Mans
Le Mans, France, 72037
C.H. Senlis
Senlis, France, 60309
C.H.G. Beauvais
Beauvais, France, 60021
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Centre Hospitalier de Lagny
Lagny Sur Marne, France, 77405
Centre Hospitalier Departemental
La Roche Sur Yon, France, F-85025
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Centre Jean Bernard
Le Mans, France, 72000
Centre Paul Papin
Angers, France, 49036
CHU Ambroise Pare
Boulogne Billancourt, France, F-92104
CHU Pitie-Salpetriere
Paris, France, 75651
Chu-Hopital Gabriel Montpied
Clermont Ferrand, France, F-63000
Clinique Saint Jean
Lyon, France, 69008
Clinique Ste - Marie
Pontoise, France, 95300
CMC Bligny
Briis Sous Forges, France, 91640
Hopital Andre Mignot
Le Chesnay, France, 78157
Hopital Beaujon
Clichy, France, 92118
Polyclinique De Courlancy
Reims, France, F-51100
Hopital de la Croix Rousse
Lyon, France, 69317
Hopital de la Croix St. Simon
Paris, France, 75020
Hopital Drevon
Dijon, France, 21000
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Haut Leveque
Pessac, France, 33604
Hopital Louis Mourier
Colombes, France, F-92701
Hopital Louis Pasteur
Chartres, France, 28018
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Hopital Robert Boulin
Libourne, France, 33500
Hopital Saint - Louis
La Rochelle, France, 17000
Hopital Saint Andre
Bordeaux, France, 33075
Hopital Saint Antoine
Paris, France, 75571
Hopital Saint-Louis
Paris, France, 75475
Hopital Tenon
Paris, France, 75970
Institut Gustave Roussy
Villejuif, France, F-94805
Intercommunal Hospital
Montfermeil, France, 93370
Maison Medicale Marzet
Pau, France, 64000
Hopital Bichat - Claude Bernard
Paris, France, 75018

Sponsors and Collaborators

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators

Investigator:

Christophe Louvet, MD, PhD

Hopital Saint Antoine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, Andre T, Zaniboni A, Ducreux M, Aitini E, Taieb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16.

Huguet F, Andre T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31.

Study ID Numbers:	CDR0000346480, FRE-GERCOR-GEM-GEMOX/D00-3, EU-20324
Study First Received:	January 9, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00075452 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Oxaliplatin
Neoplasms by Site
Therapeutic Uses
Gemcitabine
Endocrine Gland Neoplasms
Digestive System Neoplasms

Neoplasms by Histologic Type
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009