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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-9704 |
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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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin and etoposide in treating patients who have recurrent or persistent ovarian, fallopian tube, or peritoneal cancer.
OBJECTIVES: I. Determine the optimal dose of doxorubicin HCl liposomal and prolonged oral etoposide in patients with recurrent or persistent ovarian, tubal, and peritoneal carcinoma. II. Determine the nature and degree of toxicity of this therapy in these patients. III. Evaluate the response rate of patients with measurable disease.
OUTLINE: This is a dose escalation, multicenter study of etoposide and doxorubicin HCl liposome. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by oral etoposide for 8-14 days beginning on day 2. For patients who achieve partial or complete response, treatment repeats every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. For patients with stable disease, treatment repeats every 4 weeks for 6 months. In the absence of dose limiting toxicity (DLT) in the first 3 patients treated, subsequent cohorts of 3-6 patients each receive doses of etoposide for more prolonged periods. After 14 days of oral etoposide, the dose of doxorubicin HCl liposome is escalated. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed every 3 months for 1 year, then until death.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 1 year.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etoposide | Drug | |||
| pegylated liposomal doxorubicin hydrochloride | Drug |
DISEASE CHARACTERISTICS: Histologically proven recurrent or persistent ovarian, tubal, or peritoneal carcinoma of the following cell types: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell adenocarcinoma Transitional cell Endometrioid adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Malignant Brenner tumor Adenocarcinoma not otherwise specified Must not be eligible for any other higher priority phase II or phase III GOG protocol
PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT/SGPT/GGT no greater than 2.5 times normal Alkaline phosphatase no greater than 2.5 times normal No acute hepatitis Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF within normal range as determined by MUGA No congestive heart failure or unstable angina No myocardial infarction within the past 6 months Prior abnormal cardiac conduction (e.g., bundle branch block, heart block) allowed if stable for at least 6 months Other: No significant infection No septicemia Body surface area at least 1 m2 Adequate intestinal function (i.e., does not require IV hydration or nutritional support) No severe gastrointestinal bleeding No other invasive malignancies within the past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy and recovered Chemotherapy: Must have received at least 1 prior cisplatin-paclitaxel based regimen At least 3 weeks since prior chemotherapy and recovered No prior anthracycline therapy Endocrine therapy: At least 3 weeks since prior endocrine therapy and recovered Radiotherapy: No prior radiotherapy to more than 10% of bone marrow Surgery: At least 3 weeks since prior surgery and recovered
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| Name | Affiliation | Role |
|---|---|---|
| Peter G. Rose, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| CCOP - Greater Phoenix |
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| Phoenix |
| Arizona |
| 85006-2726 |
| United States |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033-0800 | United States |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States |
| Women's Cancer Center | Palo Alto | California | 94304 | United States |
| University of Colorado Cancer Center | Denver | Colorado | 80262 | United States |
| Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Emory University Hospital - Atlanta | Atlanta | Georgia | 30322 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342-1701 | United States |
| MBCCOP - Hawaii | Honolulu | Hawaii | 96813 | 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 |
| CCOP - Evanston | Evanston | Illinois | 60201 | United States |
| CCOP - Central Illinois | Springfield | Illinois | 62526 | 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 |
| Johns Hopkins Oncology Center | Baltimore | Maryland | 21287 | United States |
| Medicine Branch | Bethesda | Maryland | 20892 | United States |
| Radiation Oncology Branch | Bethesda | Maryland | 20892 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| CCOP - Ann Arbor Regional | Ann Arbor | Michigan | 48106 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Keesler Medical Center - Keesler AFB | Keesler Air Force Base | Mississippi | 39534-2576 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68131 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | 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 |
| State University of New York Health Science Center at Brooklyn | Brooklyn | New York | 11203 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | 11790-9832 | 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 |
| Brookview Research, Inc. | Winston-Salem | North Carolina | 27103 | 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 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 - St. Francis Hospital/Natalie Warren Bryant Cancer Center | Tulsa | Oklahoma | 74136 | United States |
| CCOP - Columbia River Program | Portland | Oregon | 97213 | 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 |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| CCOP - Baptist Cancer Institute | Memphis | Tennessee | 38117 | United States |
| Simmons Cancer Center - Dallas | Dallas | Texas | 75235-9154 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| NCIC-Clinical Trials Group | Kingston | Ontario | K7L 3N6 | Canada |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D001948 | Brenner Tumor |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018225 | Neoplasms, Fibroepithelial |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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