Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Determination of progression free survival after 12 months of FU

Determination of total survival, response and quality of life

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North Eastern German Society of Gynaecological Oncology; North Eastern Germany Society of Gynaecologic Oncology
• Treatments: Carboplatin; Topotecan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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