Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer (Tax-Over)
Primary Purpose
Ovarian Neoplasms
Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
docetaxel and cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Neoplasms
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.
Sites / Locations
- Sanofi aventis administrative office
Outcomes
Primary Outcome Measures
Efficacy by response rate according to RECIST criteria and safety
Secondary Outcome Measures
Time to disease progression or relapse
Survival time
Quality of life based on the questionnaire EORTC QLQ-C30 filled by the patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00772863
Brief Title
Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and the safety of the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
docetaxel and cisplatin
Intervention Description
4 cycles Cisplatin 100 mg/m2 at every 3 weeks, after Cisplatin 4 cycles of docetaxel 100mg/m2 at every 3 weeks
Primary Outcome Measure Information:
Title
Efficacy by response rate according to RECIST criteria and safety
Time Frame
After the 2nd cycle, 4th cycle and 8th cycle and at the follow up period
Secondary Outcome Measure Information:
Title
Time to disease progression or relapse
Time Frame
Until progression througout the study
Title
Survival time
Time Frame
Througout the study
Title
Quality of life based on the questionnaire EORTC QLQ-C30 filled by the patients
Time Frame
Prior to entry, after completion of treatment and at the first follow-up visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edibe Taylan, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi aventis administrative office
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer
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