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Doxil and Gemcitabine in Recurrent Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00312650
Recruitment Status : Terminated
First Posted : April 10, 2006
Last Update Posted : January 12, 2015
Ortho Biotech, Inc.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Drug: liposomal doxorubicin and gemcitabine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer
Study Start Date : April 2006
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Primary Outcome Measures :
  1. rate of hand-foot syndrome

Secondary Outcome Measures :
  1. objective response rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • recurrent platinum resistant ovarian cancer
  • measurable disease

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00312650

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United States, Rhode Island
Women and Infants' Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Ortho Biotech, Inc.
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Principal Investigator: Paul A DiSilvestro, MD Program in Women's Oncology

Layout table for additonal information Identifier: NCT00312650     History of Changes
Other Study ID Numbers: 05-0120
First Posted: April 10, 2006    Key Record Dates
Last Update Posted: January 12, 2015
Last Verified: January 2015

Keywords provided by Women and Infants Hospital of Rhode Island:
ovarian cancer

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liposomal doxorubicin
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors