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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCAGY/ GINECO GROUP
• Treatments: Carboplatin; 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