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Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer (Tax-Over)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772863
First Posted: October 15, 2008
Last Update Posted: October 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
October 13, 2008
October 15, 2008
October 29, 2009
September 2003
June 2008   (Final data collection date for primary outcome measure)
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 ]
Efficacy by response rate and safety [ Time Frame: After the 2nd cycle, 4th cycle and 8th cycle and at the follow up period ]
Complete list of historical versions of study NCT00772863 on ClinicalTrials.gov Archive Site
  • Time to disease progression or relapse [ Time Frame: Until progression througout the study ]
  • Survival time [ Time Frame: Througout the study ]
  • 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 ]
  • Time to progression [ Time Frame: Until progression througout the study ]
  • Survival time [ Time Frame: Througout the study ]
  • Quality of life. [ Time Frame: Until the first follow up ]
Not Provided
Not Provided
 
Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer
The Evaluation of Efficacy and Safety of Subsequent Cisplatin and Docetaxel Regimen In The First Line Treatment of Advanced Epithelial Ovarian Cancer
The purpose of this study is to assess the efficacy and the safety of the treatment.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Neoplasms
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
Not Provided
June 2008   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT00772863
XRP6976I_6012
No
Not Provided
Not Provided
Medical Affairs Study Director, Sanofi aventis
Sanofi
Not Provided
Study Director: Edibe Taylan, MD Sanofi
Sanofi
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP