Status:
COMPLETED
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
Lead Sponsor:
ARCAGY/ GINECO GROUP
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
70+ years
Phase:
PHASE2
Brief Summary
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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00231075
Start Date
January 1 2001
End Date
May 1 2007
Last Update
November 3 2005
Active Locations (2)
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1
Centre Hosptalier Emile Roux
Eaubonne, France, 95600
2
Centre Hospitalier Lyon-sud
Pierre-Bénite, France, 69495