TAX + Carboplatin or Cisplatin 1st Line Post-Surgery Ovarian

NCT00539669 | Completed Phase 2

• 1 other identifier: XRP6976I_2502
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate response rate of Docetaxel in combination with Carboplatin or Cisplatin as first line chemotherapy in epithelial ovarian cancer. Assess the progression free survival, tolerance, duration of response and survival in the same patient population.

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

• The response rate will be determined by the number of patients with complete and partial responses according to the Modified SWOG Response Criteria. The progression free survival, duration of response and survival are evaluated.

Interventions

Docetaxel DRUG

Eligibility Criteria

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

You may not qualify if:

• Female, aged 18 or over- FIGO stages Ic-IV with or without successful cytoreductive surgery at staging laparotomy. Stage Ic patients will be limited to those with malignant cells in ascitic fluid, peritoneal washings or with tumour on the surface of the ovary
• Patients with ruptured capsule as the only evidence of stage Ic will not be eligible for entry into the study.
• ECOG performance status \> 2
• Prior treatment with chemotherapy or radiotherapy.
• Patients with, pre-existing fluid retention such as pleural effusion, pericardial effusion and ascites are not excluded from the study, but should be monitored closely for any deterioration. Efforts should be made to determine by cytological analysis whether any significant pre-existing fluid collections are due to ovarian cancer, and subsequent drainage is recommended before initiating chemotherapy.
• Inadequate bone marrow function defined as neutrophils \< 1.5 x 109/l or platelets \< 100 x 109/l.
• Inadequate renal function as defined by serum creatinine \> 1.25 x upper limit of normal.
• Inadequate liver function as defined by bilirubin \> upper limit of normal or AST/ALT \> 1.5 x upper limit of normal or ALP \> 3 x upper limit of normal.
• Concurrent severe and/or uncontrolled co-morbid medical condition (i.e. uncontrolled infection, hypertension, ischaemic heart disease, myocardial infarction within previous 6 months, congestive heart failure)
• Patients with mixed mesodermal tumours.
• Patients with borderline ovarian tumours or tumours termed 'possibly malignant'.
• Adenocarcinoma of unknown origin, if histologically shown to be mucin-secreting cancer or thought to be possible primary fallopian tube carcinoma.
• History of previous malignancy within the previous 5 years (except curatively treated carcinoma in situ of the uterine cervix, or basal cell carcinoma of the skin), or concurrent malignancy (e.g. coexisting endometrial cancer) .
• History of prior serious allergic reactions (e.g. anaphylactic shock).
• History of other relative contraindications to corticosteroid administration

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Seoul, South Korea

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Docetaxel

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

Study Officials

• Hyang Rim Kim

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 4, 2007
• Study Start: March 1, 2003
• Last Updated: October 4, 2007

Record last verified: 2007-10

Locations

KR (1)