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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00030472 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness liposomal doxorubicin in treating patients who have persistent or recurrent cancer of the cervix.
Condition | Intervention | Phase |
---|---|---|
Cervical Cancer |
Drug: pegylated liposomal doxorubicin hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix |
Study Start Date: | December 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma (SCC) of the cervix
1 prior chemotherapeutic regimen for SCC of the cervix required
At least 1 unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Community Hospital of Los Gatos | |
Los Gatos, California, United States, 95032 | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1740 | |
United States, Hawaii | |
MBCCOP - Hawaii | |
Honolulu, Hawaii, United States, 96813 | |
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | |
Iowa City, Iowa, United States, 52242-1009 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 | |
United States, Massachusetts | |
Tufts - New England Medical Center | |
Boston, Massachusetts, United States, 02111 | |
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States, 08103-1489 | |
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 | |
State University of New York Health Sciences Center - Stony Brook | |
Stony Brook, New York, United States, 11794-8091 | |
United States, North Carolina | |
Lineberger Comprehensive Cancer Center, UNC | |
Chapel Hill, North Carolina, United States, 27599-7295 | |
United States, Ohio | |
Charles M. Barrett Cancer Center at University Hospital | |
Cincinnati, Ohio, United States, 45267-0526 | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Abington Memorial Hospital | |
Abington, Pennsylvania, United States, 19001-3788 | |
United States, Texas | |
University of Texas M.D. Anderson CCOP Research Base | |
Houston, Texas, United States, 77030-4009 | |
University of Texas Medical Branch | |
Galveston, Texas, United States, 77555-0587 | |
United States, Vermont | |
Fletcher Allen Health Care - Medical Center Campus | |
Burlington, Vermont, United States, 05401 | |
Norway | |
Norwegian Radium Hospital | |
Oslo, Norway, N-0310 |
Study Chair: | Peter G. Rose, MD | MetroHealth Cancer Care Center at MetroHealth Medical Center |
Study ID Numbers: | CDR0000069168, GOG-0127R |
Study First Received: | February 14, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00030472 |
Health Authority: | United States: Federal Government |
recurrent cervical cancer stage IVB cervical cancer cervical squamous cell carcinoma |
Squamous cell carcinoma Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Doxorubicin Recurrence Carcinoma Epidermoid carcinoma |
Uterine Cervical Neoplasms Genital Diseases, Female Uterine Cervical Diseases Carcinoma, squamous cell Uterine Neoplasms Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |