Gemcitabine and Oxaliplatin in Treating Patients With Metastatic 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:
NCT00274859
First received: January 10, 2006
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 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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: gemcitabine hydrochloride
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Masking: 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

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 benefit [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Progression-free [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: August 2005
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for metastatic disease, including anthracyclines or taxanes
  • Prior hormonal therapy allowed
  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: NCT00274859

Locations
France
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 Tenon
Paris, France, 75970
Hopital Saint Antoine
Paris, France, 75571
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
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Joseph Gligorov, MD Hopital Tenon
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274859     History of Changes
Other Study ID Numbers: CDR0000454320, GERCOR-SEGEMOX-S04-1, LILLY-GERCOR-SEGEMOX-S04-1, SANOFI-GERCOR-SEGEMOX-S04-1, EU-20571
Study First Received: January 10, 2006
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
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 August 28, 2014