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:
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00231075
First received: September 30, 2005
Last updated: November 2, 2005
Last verified: September 2005

September 30, 2005
November 2, 2005
January 2001
Not Provided
Feasibility of the combination Paraplatine + Taxol (at least 6 cures have been administered for a given patient and for the treated population, 50% feasibility)
Same as current
Complete list of historical versions of study NCT00231075 on ClinicalTrials.gov Archive Site
  • Toxicity assessment
  • Overall survival
  • Progression-free survival
  • Rate of response
  • Quality of life
Same as current
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: Paraplatin
  • Drug: Paclitaxel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
May 2007
Not Provided

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
Female
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00231075
FAG-2
Not Provided
Not Provided
ARCAGY/ GINECO GROUP
Not Provided
Principal Investigator: Gilles Freyer, MD, PhD Centre Hospitalier Lyon-Sud 69495 Pierre-Bénite cedex
ARCAGY/ GINECO GROUP
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP