NCT00610792

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

An Open Label, Phase 2 Study of Biweekly VELCADE and Intermittent CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (estimated)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	bortezomib	1.3 mg/m2 on Days 1, 4, 8 \& 11 every 3 weeks (1 cycle = 21 days) for up to six cycles
DRUG	pegylated liposomal doxorubicin	30 mg/m2 on Day 1 every 3 weeks (1 cycle = 21 days) for up to six cycles

Timeline

• Start date: 2006-07-01
• Primary completion: 2009-09-01
• First posted: 2008-02-08
• Last updated: 2009-07-14

Locations

7 sites across 2 countries: Italy, Switzerland