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


N/A
15 Years
75 Years
Not Enrolling
Female
Ovarian Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

At baseline and from administration of drug to end of treatment

Safety Issue:

No

Principal Investigator

Rezaul-Farid Khan, Dr

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Bangladesh: Bangladesh Medical Research Council

Study ID:

TAX_BD1_601

NCT ID:

NCT00452985

Start Date:

February 2002

Completion Date:

November 2010

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms

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