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Taxol Carboplatin and Erythropoetin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:
NCT00158379
First received: September 9, 2005
Last updated: December 12, 2016
Last verified: December 2016

September 9, 2005
December 12, 2016
July 2003
April 2008   (Final data collection date for primary outcome measure)
Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25% [ Time Frame: every 3 months for up to 3 years ]
Time to progression
Not Provided
Complete list of historical versions of study NCT00158379 on ClinicalTrials.gov Archive Site
Toxicity [ Time Frame: after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years ]
defined as hematological and non-hematological adverse events of grade >= grade 1
Not Provided
Not Provided
Not Provided
 
Taxol Carboplatin and Erythropoetin
Carboplatin With Following Taxol® Therapy Under Additional Application of Epoetin Alfa (ERYPO ®) With Female Patients With Advanced Ovarian Cancer FIGO IA/G3 - IV
Time to progression (physical examination and radiologic imaging
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
Drug: Paclitaxel
4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
Experimental: Paclitaxel
Intervention: Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
June 2008
April 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00158379
3002000
No
Not Provided
No
Not Provided
North Eastern Germany Society of Gynaecologic Oncology
North Eastern Germany Society of Gynaecologic Oncology
Not Provided
Principal Investigator: Jalid Sehouli Charite University, Berlin, Germany
North Eastern Germany Society of Gynaecologic Oncology
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP