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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


Phase 2
70 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Feasibility of the combination Paraplatine + Taxol (at least 6 cures have been administered for a given patient and for the treated population, 50% feasibility)

Principal Investigator

Gilles Freyer, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Lyon-Sud 69495 Pierre-Bénite cedex

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

FAG-2

NCT ID:

NCT00231075

Start Date:

January 2001

Completion Date:

May 2007

Related Keywords:

  • Ovarian Cancer
  • Epithelial ovary cancer F.I.G.O. stages III or IV
  • 70 years or older
  • Ovarian Neoplasms

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