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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

About this trial

This is an interventional treatment trial for Ovarian Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

NCT ID

NCT00772863

First Posted

October 13, 2008

Last Updated

October 28, 2009

Sponsor

Sanofi

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

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

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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