Taxol Carboplatin and Erythropoetin
- Registration Number
- NCT00158379
- Brief Summary
Time to progression (physical examination and radiologic imaging
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 105
Inclusion Criteria
- 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 Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Paclitaxel Paclitaxel -
- Primary Outcome Measures
Name Time Method Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25% every 3 months for up to 3 years Time to progression
- Secondary Outcome Measures
Name Time Method Toxicity after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years defined as hematological and non-hematological adverse events of grade \>= grade 1