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Evaluation of the Safety and Efficacy of Paraplatin in Combination With Taxol in Patients of 70 Years and Older With Ovary Cancer F.I.G.O. Stages III-IV

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00231075
First Posted: October 4, 2005
Last Update Posted: December 9, 2005
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.
Information provided by:
ARCAGY/ GINECO GROUP
  Purpose
Safety and Efficacy of Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV.

Condition Intervention Phase
Ovarian Cancer Drug: Paraplatin Drug: Paclitaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: National, Phase II Study Designed to Evaluate the Safety and Efficacy of Paraplatin in Combination With Taxol in Patients of 70 Years and Older With Ovary Cancer F.I.G.O. Stages III and IV. FAG-2

Resource links provided by NLM:


Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:
  • Feasibility of the combination Paraplatine + Taxol (at least 6 cures have been administered for a given patient and for the treated population, 50% feasibility)

Secondary Outcome Measures:
  • Toxicity assessment
  • Overall survival
  • Progression-free survival
  • Rate of response
  • Quality of life

Estimated Enrollment: 75
Study Start Date: January 2001
Estimated Study Completion Date: May 2007
Detailed Description:
The Main objective of this study is to evaluate the faisibility of chemotherapy with Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV and to determine principal predictive factors of this feasibility.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological proven diagnosis of epithelial ovary cancer F.I.G.O stages III or IV (when only cytological proven diagnosis is available: malignant cells and pelvis tumoral mass and increased CA-125 must be diagnosed simultaneously)
  • Patient aged > 70 years
  • Neutrophil polynuclears > 1500/mm3 and Platelets > 100 000/mm3
  • No clinical icterus
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Previous diagnosis of malignancy
  • Previous chemotherapy treatment
  • Previous radiotherapy
  • Hypersensitivity to products containing Cremophore EL
  • Hepatic values: bilirubine > 2*LSN, SGOT-SGPT > 2*LSN and/or Alkalin phosphatase > 3*LSN
  • Myocardiopathy with arrhythmia
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00231075


Locations
France
Centre Hosptalier Emile Roux
Eaubonne, France, 95600
Centre Hospitalier Lyon-sud
Pierre-Bénite, France, 69495
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
Principal Investigator: Gilles Freyer, MD, PhD Centre Hospitalier Lyon-Sud 69495 Pierre-Bénite cedex
  More Information

ClinicalTrials.gov Identifier: NCT00231075     History of Changes
Other Study ID Numbers: FAG-2
First Submitted: September 30, 2005
First Posted: October 4, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by ARCAGY/ GINECO GROUP:
Epithelial ovary cancer F.I.G.O. stages III or IV
70 years or older

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Antineoplastic Agents