Clinical trial · Interventional
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
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
NCT00231075CI-TRIAL-00000197completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Paraplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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)
Secondary outcomes (5)
- measure
- Toxicity assessment
- measure
- Overall survival
- measure
- Progression-free survival
- measure
- Rate of response
- measure
- Quality of life
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.