Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer

NCT ID: NCT00772863

Last Updated: 2009-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30

Brief Summary

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

Conditions

Ovarian Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Sanofi aventis

Principal Investigators

Edibe Taylan, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi aventis administrative office

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

XRP6976I_6012

Identifier Type: -

Identifier Source: org_study_id