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

NCT ID: NCT00539669

Last Updated: 2007-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Docetaxel

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• 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
• Pregnant or lactating women (or potentially fertile women not using adequate contraception).
• Symptomatic peripheral neuropathy > NCIC-CTC grade II.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Principal Investigators

Hyang Rim Kim

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Seoul, , South Korea

Countries

South Korea

Other Identifiers

XRP6976I_2502

Identifier Type: -

Identifier Source: org_study_id