Clinical trial NCT00452985: Docetaxel and Carboplatin as First-line Chemotherapy in Early Stage as Well as Advanced or Metastatic Ovarian Cancer
Official title: Randomised Study With Docetaxel, Cisplatin and Cyclophosphamide vs Docetaxel and Carboplatin as First Line Chemotherapy With Advanced or Metastatic Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced or metastatic ovarian cancer

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measurements of the disease (assessed clinically and/or by CA-125)
timeFrame: At baseline and from administration of drug to end of treatment
measure: Response rate
timeFrame: From start to end of treatment
measure: 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.
timeFrame: From the beginning to the end of study
measure: Adverse events
timeFrame: From the beginning to the end of the study
Secondary outcomes:
measure: Progression free survival
timeFrame: From administration of drug up to end of study
measure: Overall survival
timeFrame: From administration of drug to end of study
measure: Biology and Hematology laboratory determinations
timeFrame: From the beginning to the end of the study
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Rezaul-Farid Khan, Dr
role: STUDY_DIRECTOR
References: