The Evaluation of Efficacy and Safety of Subsequent Cisplatin and Docetaxel Regimen In The First Line Treatment of Advanced Epithelial Ovarian Cancer

Sanofi1 site in 1 country37 target enrollmentSeptember 2003

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ovarian Neoplasms
Sponsor: Sanofi
Enrollment: 37
Locations: 1
Primary Endpoint: Efficacy by response rate according to RECIST criteria and safety
Status: Completed
Last Updated: 16 years ago

The purpose of this study is to assess the efficacy and the safety of the treatment.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

June 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Sponsor

•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)

•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.

Efficacy by response rate according to RECIST criteria and safety

Time Frame: After the 2nd cycle, 4th cycle and 8th cycle and at the follow up period

Time to disease progression or relapse(Until progression througout the study)
Survival time(Througout the study)
Quality of life based on the questionnaire EORTC QLQ-C30 filled by the patients(Prior to entry, after completion of treatment and at the first follow-up visit)