Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00274859
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2006
Last Update Posted : July 24, 2008
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: gemcitabine hydrochloride Drug: oxaliplatin Phase 2

Detailed Description:



  • Determine the objective response rate in patients with metastatic cancer not amenable to anthracycline or taxane therapy treated with gemcitabine hydrochloride and oxaliplatin.


  • Determine the clinical benefit and tolerability of this regimen in these patients.
  • Determine the progression-free and overall survival of patients treated with this regimen.

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

Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Study Evaluating Gemcitabine and Oxaliplatin in the Treatment of Patients Suffering From Metastatic Breast Cancer Who Are Not Candidates For Treatment With Antracyclines and Taxanes
Study Start Date : August 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Objective response rate

Secondary Outcome Measures :
  1. Clinical benefit
  2. Tolerability
  3. Progression-free
  4. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed cancer

    • Metastatic disease
  • Measurable metastatic disease ≥ 1 cm by spiral CT scan and/or cutaneous lesion ≥ 2 cm
  • Not a candidate for anthracycline or taxane chemotherapy
  • No brain metastases


  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • Neutrophil count > 1,000/mm^3
  • Platelet count > 100,000/mm^3
  • Alkaline phosphatase < 5 times upper limit of normal (ULN)
  • Bilirubin < 1.5 times ULN
  • Creatinine < 1.5 times ULN OR creatinine clearance > 30 mL/min
  • SGOT and SGPT < 3 times ULN (5 times ULN if liver metastases present)
  • No pre-existing neuropathy
  • Not pregnant or nursing
  • No uncontrolled hypercalcemia
  • No familial, social, geographical, or psychological condition that would preclude study treatment
  • No other malignancy that is not considered cured


  • No prior chemotherapy for metastatic disease, including anthracyclines or taxanes
  • Prior hormonal therapy allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00274859

C.H.G. Beauvais
Beauvais, France, 60021
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Centre Hospitalier Docteur Duchenne
Boulogne Sur Mer, France, 62200
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Intercommunal Hospital
Montfermeil, France, 93370
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Polyclinique De Courlancy
Reims, France, F-51100
Centre Rene Huguenin
Saint Cloud, France, 92210
Centre Hospitalier de Saint-Quentin
Saint-Quentin, France, 02321
C.H. Senlis
Senlis, France, 60309
Centre Paul Strauss
Strasbourg, France, 67065
Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
Toulon - Cedex, France, 83056
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Chair: Joseph Gligorov, MD Hopital Tenon Identifier: NCT00274859     History of Changes
Other Study ID Numbers: CDR0000454320
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: May 2007

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs