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

This is an interventional treatment trial for Ovarian Cancer Read More

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

Exclusion Criteria:

• Chemotherapy, hormonal, radiation or immunotherapy or participation in any investigational drug study within 4 weeks of study entry
• Pre-existing peripheral neuropathy > Grade 1
• Presence of cirrhosis or active or chronic hepatitis
• Presence of serious cardiac (congestive heart failure, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorder
• Presence of uncontrolled intercurrent illness or any condition which in the judgment of the Investigator would place the subject at undue risk or interfere with the results of the study
• Symptomatic brain metastases or leptomeningeal disease
• Pregnancy or lactation or unwillingness to use adequate method of birth control
• Active infection
• Known history of allergy to mannitol, boron or liposomally formulated drugs.