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Keep this study
Lead
Russian Academy of Medical Sciences
OBJECTIVES:
* To investigate the efficacy and safety of paclitaxel and cisplatin as first-line chemotherapy in patients with stage IC-IV ovarian epithelial cancer.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV and cisplatin IV once every 2 weeks. Treatment repeats every 2 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Age
18–72
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed epithelial adenocarcinoma of the ovary
* Stage IC-IV disease
No known or clinical evidence of brain metastasis
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Hemoglobin must be ≥ 90 g/L
ANC ≥ 2 x 10\^9/L
Platelet count ≥ 100 x10\^9/L
Serum creatinine ≤ 115 μmol/L
Total bilirubin ≤ 25 μmol/L
Not pregnant or nursing
No other serious disease which could affect protocol compliance and results
No other prior malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix or squamous carcinoma of the skin
No peripheral neuropathy ≥ CTCAE version 3.0 grade 2
No known hypersensitivity to any of the study drugs or their excipients
No drug addiction or alcoholism
No disorder which leads to the condition that contraindicates the use of the investigational drugs, or that may affect the patient's compliance with the study requirements
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiotherapy for ovarian cancer