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

Sanofi

Status: Completed

Conditions: Ovarian Neoplasms

Treatments: Drug: Carboplatin; Drug: Docetaxel

Study type: Observational

Funder types: Industry

Identifiers

NCT00452985

TAX_BD1_601

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

1

Description:

* Injection of Docetaxel * 3-hour gap * Injection of carboplatin

Treatment:

Drug: Carboplatin

Drug: Docetaxel