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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00772863
First received: October 13, 2008
Last updated: October 28, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Ovarian Neoplasms
Drug: docetaxel and cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression or relapse [ Time Frame: Until progression througout the study ] [ Designated as safety issue: No ]
  • Survival time [ Time Frame: Througout the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: September 2003
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772863

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

No publications provided

Responsible Party: Medical Affairs Study Director, Sanofi aventis
ClinicalTrials.gov Identifier: NCT00772863     History of Changes
Other Study ID Numbers: XRP6976I_6012
Study First Received: October 13, 2008
Last Updated: October 28, 2009
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014