Conditions: Ovarian Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 110
Healthy volunteers: no

Brief summary:
This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer.

100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1.

Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727.

Others endpoints: biomarkers and pharmacogenetics analysis (optional)

Detailed description:

Arms:
arm 1: Patients receive BI 6727 infusion every 3 weeks arm 2: At the investigator discretion, patient will receive one of the following cytotoxics: topotecan, paclitaxel, gemcitabine or liposomal doxorubicin

Interventions: intervention 1: Paclitaxel intervention 2: Gemcitabine intervention 3: Topotecan intervention 4: Pegylated liposomal doxorubicin (PLD) intervention 5: BI 6727
Intervention descriptions: intervention 1: Patients receive paclitaxel in a 4 week schedule intervention 2: Patients receive gemcitabine in a 3 week schedule intervention 3: Patients receive topotecan in 3 or 4 week schedule intervention 4: Patients receive PLD in a 4 week schedule intervention 5: Patients receive BI 6727 infusion every 3 weeks

Protocol document: