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

ARCAGY/ GINECO GROUP

Status and phase: Completed; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: Paclitaxel; Drug: Paraplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00231075

FAG-2

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)