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Doxil and Gemcitabine in Recurrent Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00312650
Recruitment Status : Terminated
First Posted : April 10, 2006
Last Update Posted : January 12, 2015
Sponsor:
Collaborator:
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.

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


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

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 ClinicalTrials.gov identifier (NCT number): NCT00312650


Locations
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.
Investigators
Principal Investigator: Paul A DiSilvestro, MD Program in Women's Oncology

ClinicalTrials.gov 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
recurrent
progressive

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Gemcitabine
Doxorubicin
Liposomal doxorubicin
Antimetabolites, Antineoplastic
Antimetabolites
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
Topoisomerase Inhibitors