Docetaxel and Carboplatin as First-line Chemotherapy in Early Stage as Well as Advanced or Metastatic Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Randomised Study With Docetaxel, Cisplatin and Cyclophosphamide vs Docetaxel and Carboplatin as First Line Chemotherapy With Advanced or Metastatic Ovarian Cancer

Conditions
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Ovarian Neoplasms

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Injection of Docetaxel 3-hour gap Injection of carboplatin | Drug: Docetaxel<br>* 60-75 mg/m²<br>Drug: Carboplatin<br>* AUC 5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |