Ovarian Cancer Clinical Trial
Official title:
A Phase I Study of Liposomal Doxorubicin (Doxil) and Prolonged Etoposide As Second Line Therapy in Ovarian, Tubal and Peritoneal Carcinoma
Verified date | October 2002 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | July 2002 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | NCIC-Clinical Trials Group | Kingston | Ontario |
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | Cancer Center of Albany Medical Center | Albany | New York |
United States | CCOP - Ann Arbor Regional | Ann Arbor | Michigan |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | Johns Hopkins Oncology Center | Baltimore | Maryland |
United States | Medicine Branch | Bethesda | Maryland |
United States | Radiation Oncology Branch | Bethesda | Maryland |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | University of Alabama Comprehensive Cancer Center | Birmingham | Alabama |
United States | State University of New York Health Science Center at Brooklyn | Brooklyn | New York |
United States | Cooper Hospital/University Medical Center | Camden | New Jersey |
United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Barrett Cancer Center, The University Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic Cancer Center | Cleveland | Ohio |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio |
United States | Simmons Cancer Center - Dallas | Dallas | Texas |
United States | University of Colorado Cancer Center | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | CCOP - Evanston | Evanston | Illinois |
United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | MBCCOP - Hawaii | Honolulu | Hawaii |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | Keesler Medical Center - Keesler AFB | Keesler AFB | Mississippi |
United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center | Los Angeles | California |
United States | North Shore University Hospital | Manhasset | New York |
United States | CCOP - Baptist Cancer Institute | Memphis | Tennessee |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | University of Oklahoma College of Medicine | Oklahoma City | Oklahoma |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Women's Cancer Center | Palo Alto | California |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | Pennsylvania Hospital | Philadelphia | Pennsylvania |
United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
United States | CCOP - Greater Phoenix | Phoenix | Arizona |
United States | CCOP - Columbia River Program | Portland | Oregon |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | University of Washington Medical Center | Seattle | Washington |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | CCOP - Central Illinois | Springfield | Illinois |
United States | State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York |
United States | Tacoma General Hospital | Tacoma | Washington |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
United States | CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | Tulsa | Oklahoma |
United States | Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington | District of Columbia |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
United States | Brookview Research, Inc. | Winston-Salem | North Carolina |
United States | Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
United States | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
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