Status:
UNKNOWN
Paclitaxel and Cisplatin as First-Line Treatment for Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer
Lead Sponsor:
Russian Academy of Medical Sciences
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-72 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving...
Detailed Description
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 stu...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00964626
Start Date
April 1 2009
Last Update
August 26 2013
Active Locations (1)
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1
Russian Academy of Medical Sciences Cancer Research Center
Moscow, Russia, 115478