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Taxol Carboplatin and Erythropoetin

N

North Eastern German Society of Gynaecological Oncology

Status and phase

Completed
Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: Paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00158379
3002000

Details and patient eligibility

About

Time to progression (physical examination and radiologic imaging

Enrollment

105 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

105 participants in 1 patient group

Paclitaxel
Experimental group
Treatment:
Drug: Paclitaxel

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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