Doxil and Gemcitabine in Recurrent Ovarian Cancer

Women and Infants Hospital of Rhode Island

Status and phase: Terminated; Phase 2

Conditions: Ovarian Carcinoma

Treatments: Drug: liposomal doxorubicin and gemcitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00312650

05-0120

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• recurrent platinum resistant ovarian cancer
• measurable disease

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)