Status:
COMPLETED
Taxol Carboplatin and Erythropoetin
Lead Sponsor:
North Eastern German Society of Gynaecological Oncology
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Time to progression (physical examination and radiologic imaging
Eligibility Criteria
Inclusion
- patients with primary ovarian cancer
- ECOG- 0-2
- Age \>= 18
- no chemotherapy, radiation or immunotherapy in medical history for ovarian cancer
- adequate bone marrow, liver and kidney reserve: leukocytes ≥ 2.0 x 109/l, platelets ≥ 100 x 109/l, bilirubin \<= 2,0 mg%, creatinine \<= 1,5 mg% or creatinine clearance ≥ 60 ml/ min, hemoglobin ≥ 9 g/ dl SGOT, SGPT an AP within 3 fold of the reference laboratory's normal range
- written informed consent
Exclusion
- before-existing heart illness, Cardiac infarct within last 6 months
- Radiotherapy within 4 weeks for study entry
- Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intrauterine devices, surgical methods of sterilization, or, in hormone insensitive tumors only, oral, subcutaneous or transvaginal hormonal, non-estrogen containing contraceptives)
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00158379
Start Date
July 1 2003
End Date
June 1 2008
Last Update
February 6 2017
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