Trial | NCT00231075  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    75
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.
Study Started
Jan 31
2001
Study Completion
May 31
2007
Last Update
Nov 03
2005
Estimate

Drug Paraplatin

Drug Paclitaxel

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
No Results Posted