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

Completed

• Conditions: Ovarian Neoplasms
• Interventions: Drug: Docetaxel; Drug: Carboplatin

• Registration Number: NCT00452985
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2007-03-27
• Study First Submitted QC: 2007-03-27
• Study First Posted: 2007-03-28
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-13
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Docetaxel	* Injection of Docetaxel * 3-hour gap * Injection of carboplatin
1	Carboplatin	* Injection of Docetaxel * 3-hour gap * Injection of carboplatin

Primary Outcome Measures

Name	Time	Method
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
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
Adverse events	From the beginning to the end of the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇧🇩 Dhaka, Bangladesh