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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00231075

Enrollment

Registered

2005-10-04

Start date

2001-01-31

Completion date

2007-05-31

Last updated

2005-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Epithelial ovary cancer F.I.G.O. stages III or IV, 70 years or older

Brief summary

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.

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.

Interventions

DRUGParaplatin

DRUGPaclitaxel

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

70 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Toxicity assessment	—
Overall survival	—
Progression-free survival	—
Rate of response	—
Quality of life	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026