Phase 2 Study of Twice Weekly VELCADE and CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens

Inclusion Criteria

• •Histologically/cytologically confirmed diagnosis of ovarian carcinoma of epithelial origin, primary tubal or peritoneal carcinoma;
• •Progressive or recurrent disease
• •The following patient types based upon the disease measurability may enroll in this study and will be considered for efficacy evaluation.
• •Patients may have measurable disease strictly following the RECIST guidelines. CA125 levels must be obtained according to the Rustin guidelines to enable a complete evaluation of response/progressive disease according to the GCIG guidelines. Patients may enter with a solitary measurable lesion which has not been confirmed by histology/cytology. These patients will be considered evaluable for response according to a modified RECIST which will not require the histological/cytological confirmation of the lesion. CA125 levels must be obtained according to the Rustin guidelines to enable a complete evaluation of progressive disease according to the GCIG guidelines. Patients with non-measurable disease will be considered evaluable for response provided CA125 data has been collected according to the Rustin guidelines and a complete evaluation of response/progressive disease according to the GCIG guidelines maybe conducted.
• •Numbers of prior chemotherapy(s): maximum 2 prior chemotherapies. Reintroduction of a platinum at relapse, after an initial response lasting \> 6 months is considered 1 chemotherapy regimen only.
• •ECOG performance status grade 0 or 1
• •Age ≥ 18 and ≤ 75 yrs
• •Adequate hematological, liver and renal function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1.50 x 109/L; platelets ≥ 100 x 109/L, bilirubin within UNL; alkaline phosphatase ≤ 1.5 x UNL; ALT, AST ≤ UNL or ≤ 2.5 x UNL in case of liver metastases; albumin ≥ 2.5 g/dL; creatinine ≤ UNL
• •Life expectancy of at least 3 months
• •Prior anthracycline limited to doxorubicin equivalent of 280mg/m2 with progression free interval of at least 12 months for patients who have been pre-treated with CAELYX
• •LVEF must be within normal limits
• •Signed and dated informed consent