Randomised Study With Docetaxel, Cisplatin and Cyclophosphamide vs Docetaxel and Carboplatin as First Line Chemotherapy With Advanced or Metastatic Ovarian Cancer
- Performance status Karnofsky index ≥ 60%.
- Early stage as well as advanced/metastatic ovarian cancer proven by abdominal
ultrasonography, chest x-ray, Computerized axial tomography scan.
- Histologically: epithelial/germ cell
- Haematology: absolute neutrophil count: ≥2X10^9/L; Platelet: ≥150X10^9/L;
Haemoglobin: ≥ 10g/dL
- Liver function: total bilirubin: ≤1X UNL (upper normal limit); Aspartate transaminase
& Alanine aminotransferase: ≤2.5 x UNL; Alkaline phosphatase: ≤2.5 UNL
- Renal function: Creatinine: ≤130 µmol/L; If creatinine > 130 µmol/L, the 24 hour
creatinine clearance should be > 60 ml/min.
- Symptomatic peripheral neuropathy > grade 1 by National Cancer Institute - Common
Toxicity Criteria scale
- Uncontrolled diabetes mellitus and uncontrolled hypertension
- Pregnant, or lactating patients(patients of childbearing potential must be using
- Active infection or other serious underlying medical condition not compatible with
program entry eg. congestive heart failure, previous myocardial infarction within 6
months prior to treatment.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.