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

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. Identifier: NCT00772863
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : October 29, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Drug: docetaxel and cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2003
Actual Primary Completion Date : June 2008

Intervention Details:
  • 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

Primary Outcome Measures :
  1. 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 Measures :
  1. Time to disease progression or relapse [ Time Frame: Until progression througout the study ]
  2. Survival time [ Time Frame: Througout the study ]
  3. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00772863

Sanofi aventis administrative office
Istanbul, Turkey
Sponsors and Collaborators
Study Director: Edibe Taylan, MD Sanofi

Responsible Party: Medical Affairs Study Director, Sanofi aventis Identifier: NCT00772863     History of Changes
Other Study ID Numbers: XRP6976I_6012
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: October 29, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action