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

Phase 2

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT00231075
• Lead Sponsor: ARCAGY/ GINECO GROUP

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 III and IV and to determine principal predictive factors of this feasibility.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2001-01
• Status Verified: 2005-09
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-04
• Last Update Submitted: 2005-11-02
• Last Update Posted: 2005-11-03
• Study Completion: 2007-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of the combination Paraplatine + Taxol (at least 6 cures have been administered for a given patient and for the treated population, 50% feasibility)

Secondary Outcome Measures

Name	Time	Method
Toxicity assessment
Overall survival
Progression-free survival
Rate of response
Quality of life

Trial Locations

Locations (2)

Centre Hospitalier Lyon-sud; 🇫🇷 Pierre-Bénite, France

Centre Hosptalier Emile Roux; 🇫🇷 Eaubonne, France