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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-0087J |
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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 of liposomal doxorubicin in treating patients who have advanced or recurrent sarcoma of the uterus.
OBJECTIVES: I. Estimate the antitumor activity of doxorubicin HCl liposome in patients with recurrent or advanced uterine sarcoma. II. Determine the nature and degree of toxicity of this drug in this patient population.
OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 1-1.5 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegylated liposomal doxorubicin hydrochloride | Drug |
DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent or recurrent uterine sarcoma with documented disease progression after appropriate local therapy Leiomyosarcoma Malignant mixed mullerian tumor (mixed mesodermal tumor, mixed heterologous mesenchymal sarcoma) Mixed malignant Muellerian tumor (carcinosarcoma, homologous mesenchymal sarcoma) Endometrial stromal sarcoma Other uterine sarcomas Considered incurable Bidimensionally measurable disease consisting of abdominal, pelvic, chest, or other masses by palpation, x-ray, computed tomography, or ultrasound
PATIENT CHARACTERISTICS: Age: Over 21 Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: LVEF normal by MUGA scan Other: No clinically significant infection No other malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior therapy with cytotoxic drugs No prior doxorubicin HCl liposome No prior doxorubicin greater than 360 mg/m2 No other concurrent antineoplastic agents Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy No prior radiotherapy for any other malignancy Surgery: Recovered from prior surgery Other: No other concurrent investigational agents
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| Name | Affiliation | Role |
|---|---|---|
| Gregory P. Sutton, MD | Indiana University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| CCOP - Greater Phoenix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15721421 | Result | Sutton G, Blessing J, Hanjani P, Kramer P; Gynecologic Oncology Group. Phase II evaluation of liposomal doxorubicin (Doxil) in recurrent or advanced leiomyosarcoma of the uterus: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Mar;96(3):749-52. doi: 10.1016/j.ygyno.2004.11.036. |
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| Phoenix |
| Arizona |
| 85006-2726 |
| United States |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States |
| Community Hospital of Los Gatos | Los Gatos | California | 95032 | United States |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| University of Colorado Cancer Center | Denver | Colorado | 80262 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5265 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | 40536-0084 | United States |
| Radiation Oncology Branch | Bethesda | Maryland | 20892 | United States |
| Tufts University School of Medicine | Boston | Massachusetts | 02111 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Ellis Fischel Cancer Center | Columbia | Missouri | 65203 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65807 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Cooper Hospital/University Medical Center | Camden | New Jersey | 08103 | United States |
| Cancer Center of Albany Medical Center | Albany | New York | 12208 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | 11790-7775 | United States |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157-1082 | United States |
| Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | 45219 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Oklahoma College of Medicine | Oklahoma City | Oklahoma | 73190 | United States |
| CCOP - Sooner State | Tulsa | Oklahoma | 74136 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Brookview Research, Inc. | Nashville | Tennessee | 37203 | United States |
| Simmons Cancer Center - Dallas | Dallas | Texas | 75235-9154 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Cancer Center, University of Virginia HSC | Charlottesville | Virginia | 22908 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| Tom Baker Cancer Center - Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D012509 | Sarcoma |
| D018203 | Sarcoma, Endometrial Stromal |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D018193 | Neoplasms, Complex and Mixed |
| D036821 | Endometrial Stromal Tumors |
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