Taxol Carboplatin and Erythropoetin

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)

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105 participants in 1 patient group

Paclitaxel

Experimental group

Treatment:

Drug: Paclitaxel