Phase 2
N=105
Taxol Carboplatin and Erythropoetin
Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00158379 ↗Enrolled (actual)
105
Serious AEs
12.4%
Results posted
Nov 2016
Primary outcome: Primary: Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25% — 28.8 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- North Eastern German Society of Gynaecological Oncology
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25% |
28.8 | — |
| SECONDARY Toxicity |
105 | — |
Summary
Time to progression (physical examination and radiologic imaging
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00158379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.