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.
Study Type
OBSERVATIONAL
Enrollment
30
60-75 mg/m²
AUC 5
Sanofi-Aventis
Dhaka, Bangladesh
Measurements of the disease (assessed clinically and/or by CA-125)
Time frame: At baseline and from administration of drug to end of treatment
Response rate
Time frame: From start to end of treatment
Clinical examination including neurologic examination, vital signs (blood pressure, heart rate, temperature), weight, assessment of any residual toxicity due to previous therapy, assessment of performance status.
Time frame: From the beginning to the end of study
Adverse events
Time frame: From the beginning to the end of the study
Progression free survival
Time frame: From administration of drug up to end of study
Overall survival
Time frame: From administration of drug to end of study
Biology and Hematology laboratory determinations
Time frame: From the beginning to the end of the study
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