Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer

NCT00772863 | Completed Phase 2

• 1 other identifier: XRP6976I_6012
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

• Efficacy by response rate according to RECIST criteria and safety

  After the 2nd cycle, 4th cycle and 8th cycle and at the follow up period

Secondary Outcomes (3)

• Time to disease progression or relapse

  Until progression througout the study

• Survival time

  Througout the study

• Quality of life based on the questionnaire EORTC QLQ-C30 filled by the patients

  Prior to entry, after completion of treatment and at the first follow-up visit

Interventions

docetaxel and cisplatin DRUG

4 cycles Cisplatin 100 mg/m2 at every 3 weeks, after Cisplatin 4 cycles of docetaxel 100mg/m2 at every 3 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi aventis administrative office

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Edibe Taylan, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Study Start: September 1, 2003
• Primary Completion: June 1, 2008
• Last Updated: October 29, 2009

Record last verified: 2009-10

Locations

TU (1)