Ovarian Neoplasms
Conditions
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 find out overall survival. To evaluate the safety of the study regimen.
Interventions
DRUGDocetaxel
60-75 mg/m²
DRUGCarboplatin
AUC 5
Sponsors
Sanofi
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurements of the disease (assessed clinically and/or by CA-125) | At baseline and from administration of drug to end of treatment |
| Response rate | 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. | From the beginning to the end of study |
| Adverse events | From the beginning to the end of the study |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | From administration of drug to end of study |
| Biology and Hematology laboratory determinations | From the beginning to the end of the study |
| Progression free survival | From administration of drug up to end of study |
Countries
Bangladesh
Outcome results
None listed