Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian Carcinoma

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

This trial will compare the efficacy of docetaxel/carboplatin versus docetaxel/liposomal doxorubicin in pretreated patients with advanced ovarian carcinoma and treatment free-interval of at least six months

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Carboplatin; Docetaxel; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Histologically confirmed ovarian cancer

• Stage IIIB/IV

• Failure to prior chemotherapy with paclitaxel /carboplatin regimen and treatment free interval > 6 months

• Presence of two-dimensional measurable disease.

• Life expectancy of more than 3 months.

• Age ≥ 18 years.

• Performance status (WHO) 0-2

• Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)

• Adequate liver (Bilirubin<1.5 times upper limit of normal and SGOT/SGPT<2 times upper limit of normal) and renal function (creatinine<2mg/dl)

• Informed consent

Exclusion Criteria:

• Pregnant or nursing

• Psychiatric illness or social situation that would preclude study compliance'

• Other concurrent uncontrolled illness

• Other invasive malignancy within the past 5 years except nonmelanoma skin cancer

• Other concurrent investigational agents