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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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Paraplatin
Paclitaxel
Sponsored by
ARCAGY/ GINECO GROUP
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Epithelial ovary cancer F.I.G.O. stages III or IV, 70 years or older

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Centre Hosptalier Emile Roux
  • Centre Hospitalier Lyon-sud

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 30, 2005
Last Updated
November 2, 2005
Sponsor
ARCAGY/ GINECO GROUP
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1. Study Identification

Unique Protocol Identification Number
NCT00231075
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ARCAGY/ GINECO GROUP

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Epithelial ovary cancer F.I.G.O. stages III or IV, 70 years or older

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Paraplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Toxicity assessment
Title
Overall survival
Title
Progression-free survival
Title
Rate of response
Title
Quality of life

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Freyer, MD, PhD
Organizational Affiliation
Centre Hospitalier Lyon-Sud 69495 Pierre-Bénite cedex
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hosptalier Emile Roux
City
Eaubonne
ZIP/Postal Code
95600
Country
France
Facility Name
Centre Hospitalier Lyon-sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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