Taxol Carboplatin and Erythropoetin

This study is ongoing, but not recruiting participants.

Sponsored by:	North Eastern Germany Society of Gynaecologic Oncology
Information provided by:	North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:	NCT00158379

Purpose

Time to progression (physical examination and radiologic imaging

Condition	Intervention	Phase
Ovarian Cancer	Drug: Paclitaxel	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Epoetin alfa Erythropoietin Paclitaxel

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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

Further study details as provided by North Eastern Germany Society of Gynaecologic Oncology:

Primary Outcome Measures:

Progression-free survival [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Estimated Enrollment:	105
Study Start Date:	July 2003
Estimated Study Completion Date:	June 2008

Intervention Details:

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

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158379

Sponsors and Collaborators

North Eastern Germany Society of Gynaecologic Oncology

Investigators

Principal Investigator:

Jalid Sehouli

Charité Campus Virchow Klinikum

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	3002000
Study First Received:	September 9, 2005
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00158379
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Epoetin Alfa
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms

Ovarian Diseases
Carboplatin
Genital Diseases, Female
Paclitaxel
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009