OCSTUD: Docetaxel and Carboplatin as First-line Chemotherapy in Early Stage as Well as Advanced or Metastatic Ovarian Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Injection of Docetaxel 3-hour gap Injection of carboplatin |
Drug: Docetaxel
60-75 mg/m²
Drug: Carboplatin
AUC 5
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Progression free survival [From administration of drug up to end of study]
- Overall survival [From administration of drug to end of study]
- Biology and Hematology laboratory determinations [From the beginning to the end of the study]
Eligibility Criteria
Criteria
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: ≥2X109/L; Platelet: ≥150X109/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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis | Dhaka | Bangladesh |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Rezaul-Farid Khan, Dr, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TAX_BD1_601