Status:
COMPLETED
Docetaxel and Carboplatin as First-line Chemotherapy in Early Stage as Well as Advanced or Metastatic Ovarian Cancer
Lead Sponsor:
Sanofi
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
15-75 years
Brief 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 fi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00452985
Start Date
February 1 2002
End Date
November 1 2010
Last Update
August 14 2012
Active Locations (1)
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1
Sanofi-Aventis
Dhaka, Bangladesh