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Completed

NCT Number: NCT00231075

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

70 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hosptalier Emile Roux, Eaubonne, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paraplatin

Drug

paclitaxel

Drug

Primary outcomes

  1. 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 outcomes

  1. Toxicity assessment

  2. Overall survival

  3. Progression-free survival

  4. Rate of response

  5. Quality of life

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Registry information

Official study 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

Important dates

Study start
2001
Study completion
2007
First posted
Oct 4, 2005
Registry last updated
Nov 3, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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