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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00772863
Other study ID # XRP6976I_6012
Secondary ID
Status Completed
Phase Phase 2
First received October 13, 2008
Last updated October 28, 2009
Start date September 2003

Study information

Verified date October 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and the safety of the treatment.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Histologically/cytologically confirmed, optimally debulked stage III-IV epithelial ovarian cancer excluding clear cell histology.

- ECOG Performance Status is 0-2

- No prior chemotherapy for this malignancy,

- Acceptable hematological profile (as defined by a leukocyte count = 3000/mm3, a platelet count = 100.000mm3 and Hb = 9g/100mL), and adequate renal function (as defined by serum creatinine = 1.5mg/dl or creatinine clearance by formulation = 60 mL/min), and hepatic function (as defined by bilirubin = 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) = 1.5 x maximum normal value; alkaline phosphatase = 2.5 x maximum normal value, except in case of a bone metastasis)

Exclusion Criteria:

- Concomitant use of another anti-cancer therapy

- Unstable medical condition that makes the patient unable to take part in a clinical study (congestive heart failure, serious arrythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 3 months, massive pleural, peritoneal or pericardial effusion; or presence of serious uncontrolled infection.

- Presence of other tumours different from basal cell carcinoma of the skin.

- Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used

- Social or psychological condition that render the patient inadequate for the follow-up of the study

- Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
docetaxel and cisplatin
4 cycles Cisplatin 100 mg/m2 at every 3 weeks, after Cisplatin 4 cycles of docetaxel 100mg/m2 at every 3 weeks

Locations

Country Name City State
Turkey Sanofi aventis administrative office Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy by response rate according to RECIST criteria and safety After the 2nd cycle, 4th cycle and 8th cycle and at the follow up period No
Secondary Time to disease progression or relapse Until progression througout the study No
Secondary Survival time Througout the study No
Secondary Quality of life based on the questionnaire EORTC QLQ-C30 filled by the patients Prior to entry, after completion of treatment and at the first follow-up visit No
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