S9701 Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
Phase III Randomized Trial of 12 Months vs. 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known whether giving paclitaxel for a shorter period of time is as effective as a standard course of treatment for advanced ovarian cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel given for 3 months with that of paclitaxel given for 12 months in treating patients who have stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
OBJECTIVES: I. Compare the effect of continuing paclitaxel for 12 months versus 3 months on progression free survival and overall survival in women with advanced ovarian, fallopian tube, or peritoneal cancer who attained complete remission on initial platinum (carboplatin or cisplatin) and paclitaxel based chemotherapy. II. Assess the toxic effects associated with prolonged paclitaxel administration in these patients.
OUTLINE: This is a randomized study. Patients are stratified by stage (optimal stage III vs suboptimal stage III vs stage IV), prior treatments with paclitaxel (over at least 24 hours vs over less than 24 hours), and age (65 and under vs over 65). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression or 1 year from registration, then every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 5 years.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Alabama
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Mobile, Alabama, Stany Zjednoczone, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Stany Zjednoczone, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Stany Zjednoczone, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, Stany Zjednoczone, 85724
- Arizona Cancer Center
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Tucson, Arizona, Stany Zjednoczone, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Stany Zjednoczone, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Stany Zjednoczone, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Stany Zjednoczone, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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La Jolla, California, Stany Zjednoczone, 92037
- Scripps Clinic Cancer Center
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Long Beach, California, Stany Zjednoczone, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Stany Zjednoczone, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Stany Zjednoczone, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Stany Zjednoczone, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, Stany Zjednoczone, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Stany Zjednoczone, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Stany Zjednoczone, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Stany Zjednoczone, 95817
- University of California Davis Medical Center
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Santa Rosa, California, Stany Zjednoczone, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Stany Zjednoczone, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Stany Zjednoczone, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Stany Zjednoczone, 80010
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Stany Zjednoczone, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Stany Zjednoczone, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Decatur, Illinois, Stany Zjednoczone, 62526
- CCOP - Central Illinois
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Hines, Illinois, Stany Zjednoczone, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Stany Zjednoczone, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Stany Zjednoczone, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Stany Zjednoczone, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Stany Zjednoczone, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Stany Zjednoczone, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Stany Zjednoczone, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Stany Zjednoczone, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Stany Zjednoczone, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, Stany Zjednoczone, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, Stany Zjednoczone, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Stany Zjednoczone, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Stany Zjednoczone, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109-0752
- University Of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Stany Zjednoczone, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Stany Zjednoczone, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Stany Zjednoczone, 48202
- Henry Ford Hospital
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Detroit, Michigan, Stany Zjednoczone, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Stany Zjednoczone, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, Stany Zjednoczone, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, Stany Zjednoczone, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, Stany Zjednoczone, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, Stany Zjednoczone, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Stany Zjednoczone, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Stany Zjednoczone, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Stany Zjednoczone, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Stany Zjednoczone, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Stany Zjednoczone, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Stany Zjednoczone, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Stany Zjednoczone, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, Stany Zjednoczone, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Stany Zjednoczone, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Stany Zjednoczone, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Stany Zjednoczone, 87131
- MBCCOP - University of New Mexico HSC
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New York
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New York, New York, Stany Zjednoczone, 10032
- Herbert Irving Comprehensive Cancer Center
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North Carolina
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Winston-Salem, North Carolina, Stany Zjednoczone, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Stany Zjednoczone, 45219
- Barrett Cancer Center, The University Hospital
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Cincinnati, Ohio, Stany Zjednoczone, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, Stany Zjednoczone, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Stany Zjednoczone, 43206
- CCOP - Columbus
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Dayton, Ohio, Stany Zjednoczone, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Stany Zjednoczone, 45429
- CCOP - Dayton
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Toledo, Ohio, Stany Zjednoczone, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Stany Zjednoczone, 97213
- CCOP - Columbia River Program
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Portland, Oregon, Stany Zjednoczone, 97201-3098
- Oregon Cancer Center
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South Carolina
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Greenville, South Carolina, Stany Zjednoczone, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Stany Zjednoczone, 29303
- CCOP - Upstate Carolina
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Texas
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Dallas, Texas, Stany Zjednoczone, 75216
- Veterans Affairs Medical Center - Dallas
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Fort Sam Houston, Texas, Stany Zjednoczone, 78234
- Brooke Army Medical Center
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Galveston, Texas, Stany Zjednoczone, 77555-0209
- University of Texas Medical Branch
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Lubbock, Texas, Stany Zjednoczone, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, Stany Zjednoczone, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Stany Zjednoczone, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, Stany Zjednoczone, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Stany Zjednoczone, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Stany Zjednoczone, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Stany Zjednoczone, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Stany Zjednoczone, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Stany Zjednoczone, 98104
- Swedish Cancer Institute
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Seattle, Washington, Stany Zjednoczone, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, Stany Zjednoczone, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, Stany Zjednoczone, 98405-0986
- CCOP - Northwest
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer Must have undergone an initial exploratory laparotomy with tumor debulking AND Must be FIGO stage IIIA, IIIB, IIIC, or IV at the time of initial laparotomy Must have attained a clinically defined complete remission (CR) following treatment with platinum (cisplatin or carboplatin) and paclitaxel based combination chemotherapy regimen by achieving the following: No evidence of cancer on physical examination CA-125 no greater than 35 units/mL Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Bilirubin no greater than 2.0 mg/dL Negative ascites No evidence of residual cancer on CT scan of the abdomen/pelvis or chest x-ray (or chest CT scan, if performed) No symptoms felt to be secondary to persistent malignancy Must have received a minimum of 5 and a maximum of 6 courses of chemotherapy prior to study Must register for study within 21 to 56 days after prior chemotherapy Not concurrently registered to SWOG-S9618, SWOG-S9619, SWOG-S9912, or SWOG-S0009 or front line treatment phase III GOG trials
PATIENT CHARACTERISTICS: Age: Any age Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,200/mm3 Platelet count at least 100,000/mm3 Hepatic: See Disease Characteristics Renal: See Disease Characteristics Other: No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent antitumor treatment No concurrent immunotherapy Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy Prior cisplatin allowed if initial dose at least 50 mg/m2 Prior carboplatin allowed if initial dose at least 300 mg/m2 or AUC at least 4 No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No concurrent radiotherapy No prior abdominal/pelvic irradiation Surgery: See Disease Characteristics No second look laparotomy or laparoscopy
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: paclitaxel 3 cycles
paclitaxel given for 3 cycles
|
135 mg/m2 IV every 28 days
Inne nazwy:
|
|
Eksperymentalny: paclitaxel for 12 cycles
paclitaxel given for 12 cycles
|
135 mg/m2 IV every 28 days
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
progression-free survival
Ramy czasowe: duration between date of enrollment and date first recurrence or death due to any cause.
|
duration between date of enrollment and date first recurrence or death due to any cause.
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Krzesło do nauki: Maurie Markman, MD, The Cleveland Clinic
Publikacje i pomocne linki
Publikacje ogólne
- Markman M, Liu PY, Rothenberg ML, Monk BJ, Brady M, Alberts DS. Pretreatment CA-125 and risk of relapse in advanced ovarian cancer. J Clin Oncol. 2006 Mar 20;24(9):1454-8. doi: 10.1200/JCO.2005.04.7373.
- Liu PY, Alberts DS, Monk BJ, et al.: Relationship between pretreatment CA-125 level and risk of relapse in advanced ovarian cancer (AOC) patients in a complete clinical response (CCR) who received "maintenance therapy". [Abstract] J Clin Oncol 23 (Suppl 16): A-5013, 458s, 2005.
- Liu P, Moon J, Alberts DS, et al.: A modified CA-125 progression criterion in ovarian cancer (OC) patients (pts) receiving maintenance treatment following complete clinical response (cCR) to primary therapy. [Abstract] J Clin Oncol 24 (Suppl 18): A-5080, 275s, 2006.
- Markman M, Liu P, Wilczynski S, et al.: Survival (S) of ovarian cancer (OC) patients (pts) treated on SWOG9701/GOG178: 12 versus (v) 3 cycles (C) of monthly single-agent paclitaxel (PAC) following attainment of a clinically-defined complete response (CR) to platinum (PLAT)/PAC. [Abstract] J Clin Oncol 24 (Suppl 18): A-5005, 257s, 2006.
- Markman M. Maintenance chemotherapy in advanced ovarian cancer: the US experience. Int J Gynecol Cancer. 2008 Mar-Apr;18 Suppl 1:40-3. doi: 10.1111/j.1525-1438.2007.01104.x.
- Markman M, Liu PY, Wilczynski S, Monk B, Copeland LJ, Alvarez RD, Jiang C, Alberts D; Southwest Oncology Group; Gynecologic Oncology Group. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol. 2003 Jul 1;21(13):2460-5. doi: 10.1200/JCO.2003.07.013.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Nowotwory według typu histologicznego
- Nowotwory
- Nowotwory układu moczowo-płciowego
- Nowotwory według lokalizacji
- Rak
- Nowotwory gruczołowe i nabłonkowe
- Nowotwory narządów płciowych, kobiety
- Choroby układu hormonalnego
- Choroby jajników
- Choroby przydatków
- Zaburzenia gonad
- Nowotwory gruczołów dokrewnych
- Choroby jajowodów
- Nowotwory jajnika
- Nowotwory jajowodu
- Rak, nabłonek jajnika
- Molekularne mechanizmy działania farmakologicznego
- Środki przeciwnowotworowe
- Modulatory tubuliny
- Środki antymitotyczne
- Modulatory mitozy
- Środki przeciwnowotworowe, Fitogenne
- Paklitaksel
Inne numery identyfikacyjne badania
- CDR0000065875
- U10CA032102 (Grant/umowa NIH USA)
- SWOG-S9701 (Inny identyfikator: SWOG)
- GOG-178 (Inny identyfikator: GOG)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .