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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231075
• Other study ID #: FAG-2
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2005
• Last updated: November 2, 2005
• Start date: January 2001
• Est. completion date: May 2007

Study information

• Verified date: September 2005
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Paraplatin

• Paclitaxel

Locations

Country	Name	City	State
France	Centre Hosptalier Emile Roux	Eaubonne
France	Centre Hospitalier Lyon-sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Toxicity assessment
Secondary	Overall survival
Secondary	Progression-free survival
Secondary	Rate of response
Secondary	Quality of life