Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075452
First received: January 9, 2004
Last updated: July 23, 2008
Last verified: May 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
ClinicalTrials.gov Identifier: NCT00075452     History of Changes
Other Study ID Numbers: CDR0000346480, FRE-GERCOR-GEM-GEMOX/D00-3, EU-20324
Study First Received: January 9, 2004
Last Updated: July 23, 2008
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:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014