Status:
COMPLETED
Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer
Lead Sponsor:
Sanofi
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy and the safety of the treatment.
Eligibility Criteria
Inclusion
- Histologically/cytologically confirmed, optimally debulked stage III-IV epithelial ovarian cancer excluding clear cell histology.
- ECOG Performance Status is 0-2
- No prior chemotherapy for this malignancy,
- Acceptable hematological profile (as defined by a leukocyte count ≥ 3000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl or creatinine clearance by formulation ≥ 60 mL/min), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 1.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)
Exclusion
- Concomitant use of another anti-cancer therapy
- Unstable medical condition that makes the patient unable to take part in a clinical study (congestive heart failure, serious arrythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 3 months, massive pleural, peritoneal or pericardial effusion; or presence of serious uncontrolled infection.
- Presence of other tumours different from basal cell carcinoma of the skin.
- Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
- Social or psychological condition that render the patient inadequate for the follow-up of the study
- Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)
- 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 :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00772863
Start Date
September 1 2003
Last Update
October 29 2009
Active Locations (1)
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1
Sanofi aventis administrative office
Istanbul, Turkey (Türkiye)