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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-0127R |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegylated liposomal doxorubicin hydrochloride | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma (SCC) of the cervix
Must have failed local therapeutic measures and considered incurable
1 prior chemotherapeutic regimen for SCC of the cervix required
Ineligible for a higher priority GOG protocol
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:
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| Name | Affiliation | Role |
|---|---|---|
| Peter G. Rose, MD | MetroHealth Cancer Care Center at MetroHealth Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1740 | United States | ||
| Community Hospital of Los Gatos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16478630 | Result | Rose PG, Blessing JA, Lele S, Abulafia O. Evaluation of pegylated liposomal doxorubicin (Doxil) as second-line chemotherapy of squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Aug;102(2):210-3. doi: 10.1016/j.ygyno.2005.11.048. Epub 2006 Feb 14. |
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| Los Gatos |
| California |
| 95032 |
| United States |
| MBCCOP - Hawaii | Honolulu | Hawaii | 96813 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1009 | United States |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland | 20892-1182 | United States |
| Tufts - New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103-1489 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | 11794-8091 | United States |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267-0526 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001-3788 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0587 | United States |
| University of Texas M.D. Anderson CCOP Research Base | Houston | Texas | 77030-4009 | United States |
| Fletcher Allen Health Care - Medical Center Campus | Burlington | Vermont | 05401 | United States |
| Norwegian Radium Hospital | Oslo | N-0310 | Norway |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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