Spots Global Cancer Trial Database for Phase 2 Study of Twice Weekly VELCADE and CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens
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Trial Identification
Brief Title: Phase 2 Study of Twice Weekly VELCADE and CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens
Official Title: An Open Label, Phase 2 Study of Biweekly VELCADE and Intermittent CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens
Study ID: NCT00610792
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Division of Gynecologic Oncology, Università Catholica Sacre Cuore, Campbasso, , Italy
Istituto Europeo di Oncologia (IEO), Milan, , Italy
Istituto Nazionale dei Tumori, Milan, , Italy
Dept. Procreational Medicine, Università di Pisa, Pisa, , Italy
Kantonsspital St. Gallen, St. Gallen, CH, Switzerland
Gynecologic Oncology Unit, Ospedale Sant' Anna, Turin, Switzerland
Istituto Oncologico della Svizzera Italiana, Bellinzona, , Switzerland
Contact Details
Name: Medical Monitor
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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