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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Doxorubicin
Gemcitabine
Liposomal doxorubicin
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014