Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer

Ovarian Neoplasms Clinical Trial

— Tax-Over  

Official title:

The Evaluation of Efficacy and Safety of Subsequent Cisplatin and Docetaxel Regimen In The First Line Treatment of Advanced Epithelial Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772863
• Other study ID #: XRP6976I_6012
• 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. 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

• Ovarian Neoplasms

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