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
1 other identifier
interventional
105
0 countries
N/A
Brief Summary
Time to progression (physical examination and radiologic imaging
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Jul 2003
Typical duration for phase_2 ovarian-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
November 25, 2016
CompletedFebruary 6, 2017
December 1, 2016
4.8 years
September 9, 2005
October 4, 2016
December 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 to progression
every 3 months for up to 3 years
Secondary Outcomes (1)
Toxicity
after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years
Study Arms (1)
Paclitaxel
EXPERIMENTALInterventions
4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Dr. Jalid Sehouli
- Organization
- Charite Campus Vichow Klinikum
Study Officials
- PRINCIPAL INVESTIGATOR
Jalid Sehouli
Charite University, Berlin, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 12, 2005
Study Start
July 1, 2003
Primary Completion
April 1, 2008
Study Completion
June 1, 2008
Last Updated
February 6, 2017
Results First Posted
November 25, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share