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

A Multicenter Randomized Phase II Study of Docetaxel/Carboplatin Versus Docetaxel/Pegylated Liposomal Doxorubicin as Second Line Treatment in Patients With Platinum Sensitive Disease

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

The second-line treatment in advanced ovarian cancer has been proved effective in prolonging overall survival and improving quality of life. In patients with platinum-sensitive ovarian cancer (relapsed disease after 6 months from the end of first line chemotherapy) the combination of paclitaxel/carboplatin is considered the standard treatment. Generally, the combination platinum-based chemotherapy may well be associated with a survival benefit in patients with platinum-sensitive disease. Carboplatin, pegylated doxorubicin (caelyx) docetaxel, have been approved for second-line treatment of ovarian carcinoma and seem to be active in platinum-sensitive disease.

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