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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00231075 |
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Date of registration:
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30/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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January 2001 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00231075 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Gilles Freyer, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Lyon-Sud 69495 Pierre-Bénite cedex |
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Key inclusion & exclusion 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
Age minimum:
70 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Cancer
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Intervention(s)
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Drug: Paclitaxel
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Drug: Paraplatin
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Primary Outcome(s)
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Feasibility of the combination Paraplatine + Taxol (at least 6 cures have been administered for a given patient and for the treated population, 50% feasibility)
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Secondary Outcome(s)
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Progression-free survival
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Quality of life
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Toxicity assessment
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Rate of response
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Overall survival
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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