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Carboplatin With Following Taxol® Therapy Under Additional Application of Epoetin Alfa (ERYPO ®) With Female Patients With Advanced Ovarian Cancer FIGO IA/G3 - IV


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

Carboplatin With Following Taxol® Therapy Under Additional Application of Epoetin Alfa (ERYPO ®) With Female Patients With Advanced Ovarian Cancer FIGO IA/G3 - IV


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

every 3 months

Safety Issue:

No

Principal Investigator

Jalid Sehouli

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité Campus Virchow Klinikum

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

3002000

NCT ID:

NCT00158379

Start Date:

July 2003

Completion Date:

June 2008

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms

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