Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer

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:
NCT00268411
First received: December 20, 2005
Last updated: May 23, 2008
Last verified: May 2007
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days.

PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.


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 II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical benefits and tolerability [ Designated as safety issue: Yes ]
  • Progression-free and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2004
Detailed Description:

OBJECTIVES:

Primary

  • Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin.

Secondary

  • Compare the clinical benefits and tolerability of these regimens in these patients.
  • Compare the progression-free and overall survival of patients treated with these regimens.

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

  • Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2.
  • Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1.

In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the pancreas

    • Metastatic disease
  • Measurable disease (primary tumor or metastasis)

    • At least 1 cm in diameter by spiral CT scan
  • No ampulla of Vater carcinoma or biliary adenocarcinoma
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
  • Life expectancy more than 12 weeks
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Alkaline phosphatase < 5 times normal
  • Bilirubin < 1.5 times normal
  • Creatinine < 1.5 times normal
  • No pre-existing neuropathy
  • No unstable or uncontrolled pain
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No serious cardiovascular disease
  • No serious respiratory disease
  • No uncontrolled or persistent hypercalcemia
  • No psychological, familial, social, or geographical condition that would preclude study treatment
  • No other active malignancy

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy
  • No concurrent corticosteroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268411

Locations
France
Hopital Duffaut
Avignon, France, 84902
C.H.G. Beauvais
Beauvais, France, 60021
Hopital Drevon
Dijon, France, 21000
Centre Hospitalier de Dreux
Dreux, France, 28100
Centre Hospitalier Departemental
La Roche Sur Yon, France, F-85025
Hopital Saint - Louis
La Rochelle, France, 17000
Hopital Louis Pasteur - Le Coudray
Le Coudray, France, 28630
Clinique Victor Hugo
Le Mans, France, F-72000
Polyclinique des Quatre Pavillons
Lormont, France, 33310
Clinique Saint Jean
Lyon, France, 69008
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Polyclinique De Courlancy
Reims, France, F-51100
C.H. Senlis
Senlis, France, 60309
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Christophe Louvet, MD, PhD Hopital Saint Antoine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00268411     History of Changes
Other Study ID Numbers: CDR0000453849, GERCOR-D04-1-GEMOX, EU-20569, SANOFI-GERCOR-D04-1-GEMOX
Study First Received: December 20, 2005
Last Updated: May 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
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 April 22, 2014