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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Carcinoma

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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' HospitalProvidence, Rhode Island  02905