Status:
COMPLETED
Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse
Lead Sponsor:
North Eastern German Society of Gynaecological Oncology
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Determination of progression free survival after 12 months of FU Determination of total survival, response and quality of life
Detailed Description
In Germany there are two established therapy regimes for platin sensitive ovarian cancer: the combination of carboplatin and paclitaxel as well as the combination of carboplatin with gemcitabine. Choi...
Eligibility Criteria
Inclusion
- Women ≥18 years of age with platinum-sensitive recurrent ovarian cancer occurring at least six months after completion of primary standard therapy are eligible
- Patients with measurable or assessable lesions or CA-125 ≥ 2x ULN an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2
- All patients will provide written informed consent
Exclusion
- Patients with more than two chemotherapies in their history
- Progress less than six months after completion of primary standard therapy
- Simultaneous or planned radiation
- Any known hypersensitivity to topotecan, carboplatin, paclitaxel or gemcitabine
- Patients with infection
- Patients who are pregnant or breast feeding
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT00437307
Start Date
March 1 2007
End Date
June 1 2015
Last Update
September 22 2016
Active Locations (1)
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1
Charité Campus Virchow Klinikum
Berlin, Germany, 13353