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

NCT00610792 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2009-07-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2009-09-30

Countries

  • Italy
  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00610792 on ClinicalTrials.gov