Back to resultsDoxil and Gemcitabine in Recurrent Ovarian Cancer
Primary Purpose
Ovarian Carcinoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
liposomal doxorubicin and gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Carcinoma focused on measuring ovarian cancer, recurrent, progressive
Eligibility Criteria
Inclusion Criteria: recurrent platinum resistant ovarian cancer measurable disease Exclusion Criteria: prior treatment with Doxil or Gemzar life expectancy <3months cardiac ejection fraction <50%
Sites / Locations
- Women and Infants' Hospital
Outcomes
Primary Outcome Measures
rate of hand-foot syndrome
Secondary Outcome Measures
objective response rate
Full Information
NCT ID
NCT00312650
First Posted
April 6, 2006
Last Updated
January 9, 2015
Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
Ortho Biotech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00312650
Brief Title
Doxil and Gemcitabine in Recurrent Ovarian Cancer
Official Title
A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Study Start Date
April 2006 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
Ortho Biotech, Inc.
4. Oversight
5. Study Description
Brief Summary
Standard treatment for recurrent ovarian cancer is chemotherapy with one or more drugs. One of these drugs, Doxil, can cause skin toxicity at the standard dosages. This study investigates using a lower dose given more frequently in combination with a second drug Gemcitabine.
Detailed Description
This study will evaluate the toxicities of Doxil and Gemcitabine given on an every two week basis. Our hypothesis is that toxicity will be less than that with standard dosing without any negative effect on survival. Patients will also be evaluated with CT scans every 3 months. Toxicity will be assessed with every cycle of treatment. Treatment will continue until toxicity or signs of progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Carcinoma
Keywords
ovarian cancer, recurrent, progressive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
liposomal doxorubicin and gemcitabine
Primary Outcome Measure Information:
Title
rate of hand-foot syndrome
Secondary Outcome Measure Information:
Title
objective response rate
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
recurrent platinum resistant ovarian cancer
measurable disease
Exclusion Criteria:
prior treatment with Doxil or Gemzar
life expectancy <3months
cardiac ejection fraction <50%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A DiSilvestro, MD
Organizational Affiliation
Program in Women's Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women and Infants' Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Doxil and Gemcitabine in Recurrent Ovarian Cancer
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