Doxil and Gemcitabine in Recurrent Ovarian Cancer

Phase 2

Terminated

• Conditions: Ovarian Carcinoma

• Registration Number: NCT00312650
• Lead Sponsor: Women and Infants Hospital of Rhode Island

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-06
• Study First Submitted QC: 2006-04-07
• Study First Posted: 2006-04-10
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-09
• Last Update Posted: 2015-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• recurrent platinum resistant ovarian cancer
• measurable disease

Exclusion Criteria

• prior treatment with Doxil or Gemzar
• life expectancy <3months
• cardiac ejection fraction <50%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
rate of hand-foot syndrome

Secondary Outcome Measures

Name	Time	Method
objective response rate

Trial Locations

Locations (1)

Women and Infants' Hospital; 🇺🇸 Providence, Rhode Island, United States