Docetaxel and Carboplatin as First-line Chemotherapy in Early Stage as Well as Advanced or Metastatic Ovarian Cancer
NCT ID: NCT00452985
Last Updated: 2012-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2002-02-28
2010-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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1
* Injection of Docetaxel
* 3-hour gap
* Injection of carboplatin
Docetaxel
60-75 mg/m²
Carboplatin
AUC 5
Interventions
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Docetaxel
60-75 mg/m²
Carboplatin
AUC 5
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
15 Years
75 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Rezaul-Farid Khan, Dr
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
Dhaka, , Bangladesh
Countries
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Other Identifiers
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TAX_BD1_601
Identifier Type: -
Identifier Source: org_study_id