Phase 2 Study of Twice Weekly VELCADE and CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This a Phase 2, multicenter open label, uncontrolled 2-step design. Patients will be arranged
in two groups based upon the response to their last platinum containing therapy. The two
groups are, 1) Platinum Resistant Patients: patients with progressive disease while on
platinum containing therapy or stable disease after at least 4 cycles; patients relapsing
following an objective response while still receiving treatment; patients relapsing after an
objective response within 6 months from the discontinuation of the last chemotherapy and 2)
Platinum-Sensitive Patients: patients who relapsed following an objective response after 6
months from the discontinuation of platinum containing chemotherapy. All patients will
receive pyridoxine at least 200mg by mouth daily beginning approximately one week prior to
the initiation of the combination chemotherapy and it will continue up to the end of the last
treatment cycle.