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

Ovarian Neoplasms Clinical Trial

— OCSTUD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452985
• Other study ID #: TAX_BD1_601
• Status: Completed
• Phase: N/A
• First received: March 27, 2007
• Last updated: August 13, 2012
• Start date: February 2002
• Est. completion date: November 2010

Study information

• Verified date: August 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Bangladesh Medical Research Council
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Neoplasms

Intervention

Drug:
• Docetaxel
60-75 mg/m²
• Carboplatin
AUC 5

Locations

Country	Name	City	State
Bangladesh	Sanofi-Aventis	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of the disease (assessed clinically and/or by CA-125)		At baseline and from administration of drug to end of treatment	No
Primary	Response rate		From start to end of treatment	No
Primary	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	No
Primary	Adverse events		From the beginning to the end of the study	Yes
Secondary	Progression free survival		From administration of drug up to end of study	No
Secondary	Overall survival		From administration of drug to end of study	No
Secondary	Biology and Hematology laboratory determinations		From the beginning to the end of the study	No