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DOXIL for Consolidation Therapy in Ovarian Cancer.

NCT00248248 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2011-10-12

No results posted yet for this study

Summary

The primary objective for this study is to evaluate the development, frequency and severity of hand foot syndrome (HFS) in ovarian cancer subjects treated with Doxil®, as consolidation therapy, on an every two week schedule.

The secondary objective for this study is to assess one-year progression free survival rate (PFS).

Conditions

  • Ovarian Neoplasm

Interventions

DRUG

liposomal doxorubicin

Doxil at 50mg/m2 infused over one hour every 3 or 4 weeks for 3-6 cycles

Sponsors & Collaborators

  • Ortho Biotech, Inc.

    collaborator INDUSTRY

  • Southeastern Gynecologic Oncology

    lead OTHER

Principal Investigators

  • Jeffrey F Hines, MD, FACOG · Southeastern Gynecologic Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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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 NCT00248248 on ClinicalTrials.gov