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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

This study has been completed.
Sponsor:
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00231075
First received: September 30, 2005
Last updated: November 2, 2005
Last verified: September 2005
History of Changes
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
 Drug: Paraplatin
Drug: Paclitaxel
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ARCAGY/ GINECO GROUP:

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

Estimated Enrollment: 75
Study Start Date: January 2001
Estimated Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231075

Locations
France
Centre Hosptalier Emile Roux
Eaubonne, France, 95600
Centre Hospitalier Lyon-sud
Pierre-Bénite, France, 69495
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
Principal Investigator: Gilles Freyer, MD, PhD Centre Hospitalier Lyon-Sud 69495 Pierre-Bénite cedex
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00231075     History of Changes
Other Study ID Numbers: FAG-2
Study First Received: September 30, 2005
Last Updated: November 2, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by ARCAGY/ GINECO GROUP:
Epithelial ovary cancer F.I.G.O. stages III or IV
70 years or older

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
 Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 18, 2013