Docetaxel and Carboplatin as First-line Chemotherapy in Early Stage as Well as Advanced or Metastatic Ovarian Cancer

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

Primary objective:

To assess response rate. To record the clinical improvement in relation to stage and histopathological grading.

Secondary objective:

To determine progression free survival. To find out overall survival. To evaluate the safety of the study regimen.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Carboplatin; Docetaxel

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 adequate contraception).

• 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.