Doxil and Gemcitabine in Recurrent Ovarian Cancer

This study has been terminated.
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by:
Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT00312650
First received: April 6, 2006
Last updated: February 8, 2007
Last verified: February 2007
  Purpose

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 Intervention Phase
Ovarian Carcinoma
Drug: liposomal doxorubicin and gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • rate of hand-foot syndrome

Secondary Outcome Measures:
  • objective response rate

Estimated Enrollment: 24
Study Start Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00312650     History of Changes
Other Study ID Numbers: 05-0120
Study First Received: April 6, 2006
Last Updated: February 8, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Gemcitabine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 17, 2014