A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer
18 Years
N/A
Female
Ovarian Carcinoma
Trial Information
A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer
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.
Inclusion Criteria:
- recurrent platinum resistant ovarian cancer
- measurable disease
Exclusion Criteria:
- prior treatment with Doxil or Gemzar
- life expectancy <3months
- cardiac ejection fraction <50%
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
rate of hand-foot syndrome
Principal Investigator
Paul A DiSilvestro, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Program in Women's Oncology
Authority:
United States: Institutional Review Board
Study ID:
05-0120
NCT ID:
NCT00312650
Start Date:
April 2006
Completion Date:
Related Keywords:
- Ovarian Carcinoma
- ovarian cancer
- recurrent
- progressive
- Carcinoma
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
Name | Location |
|---|---|
| Women and Infants' Hospital | Providence, Rhode Island 02905 |
