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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2007-05-31

Brief Summary

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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

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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.

Conditions

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Ovarian Cancer

Keywords

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Epithelial ovary cancer F.I.G.O. stages III or IV 70 years or older

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Paraplatin

Intervention Type DRUG

Paclitaxel

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Gilles Freyer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Lyon-Sud 69495 Pierre-Bénite cedex

Locations

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Centre Hosptalier Emile Roux

Eaubonne, , France

Site Status

Centre Hospitalier Lyon-sud

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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FAG-2

Identifier Type: -

Identifier Source: org_study_id