Doxil and Gemcitabine in Recurrent Ovarian Cancer

NCT ID: NCT00312650

Last Updated: 2015-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2006-05-31

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.

Conditions

Ovarian Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

liposomal doxorubicin and gemcitabine

Intervention Type: DRUG

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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech, Inc.

INDUSTRY

Sponsor Role: collaborator

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: lead

Principal Investigators

Paul A DiSilvestro, MD

Role: PRINCIPAL_INVESTIGATOR

Program in Women's Oncology

Locations

Women and Infants' Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

05-0120

Identifier Type: -

Identifier Source: org_study_id