Taxol Carboplatin and Erythropoetin

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158379
• Other study ID #: 3002000
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: March 24, 2016
• Start date: July 2003
• Est. completion date: June 2008

Study information

• Verified date: March 2016
• Source: North Eastern Germany Society of Gynaecologic Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Time to progression (physical examination and radiologic imaging

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Paclitaxel
4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Eastern Germany Society of Gynaecologic Oncology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		every 3 months	No
Secondary	Toxicity		after every cycle	Yes

External Links

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