Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may not be 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
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.
Clareo Health | TAX + Carboplatin or Cisplatin 1st Line Post-Surgery Ovarian