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

NCT00452985CompletedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Sanofi

Enrollment

Start Date

2002-02-01

Completion Date

2010-11-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

DocetaxelCarboplatin

Conditions

Ovarian Neoplasms

Eligibility

Age Range

15 Years – 75 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Measurements of the disease (assessed clinically and/or by CA-125)

Time frame: At baseline and from administration of drug to end of treatment

Response rate

Time frame: 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.

Time frame: From the beginning to the end of study

Adverse events

Time frame: From the beginning to the end of the study

Secondary Outcomes

Progression free survival

Time frame: From administration of drug up to end of study

Overall survival

Time frame: From administration of drug to end of study

Biology and Hematology laboratory determinations

Time frame: From the beginning to the end of the study

Locations

Sanofi-Aventis, Dhaka, Bangladesh

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.