Doxil and Gemcitabine in Recurrent Ovarian Cancer

Ovarian Carcinoma Clinical Trial

Official title:

A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00312650
• Other study ID #: 05-0120
• Status: Terminated
• Phase: Phase 2
• First received: April 6, 2006
• Last updated: January 9, 2015
• Start date: April 2006
• Est. completion date: May 2006

Study information

• Verified date: January 2015
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Carcinoma
• Ovarian Neoplasms

Intervention

Drug:
• liposomal doxorubicin and gemcitabine

Locations

Country	Name	City	State
United States	Women and Infants' Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island	Ortho Biotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of hand-foot syndrome
Secondary	objective response rate