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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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 studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Alabama
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Mobile, Alabama, Spojené státy, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Spojené státy, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Spojené státy, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, Spojené státy, 85724
- Arizona Cancer Center
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Tucson, Arizona, Spojené státy, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Spojené státy, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Spojené státy, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Spojené státy, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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La Jolla, California, Spojené státy, 92037
- Scripps Clinic Cancer Center
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Long Beach, California, Spojené státy, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Spojené státy, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Spojené státy, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Spojené státy, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, Spojené státy, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Spojené státy, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Spojené státy, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Spojené státy, 95817
- University of California Davis Medical Center
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Santa Rosa, California, Spojené státy, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Spojené státy, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Spojené státy, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Spojené státy, 80010
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, Spojené státy, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Spojené státy, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Spojené státy, 96813
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, Spojené státy, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Spojené státy, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Decatur, Illinois, Spojené státy, 62526
- CCOP - Central Illinois
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Hines, Illinois, Spojené státy, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Spojené státy, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Spojené státy, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Spojené státy, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Spojené státy, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Spojené státy, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Spojené státy, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Spojené státy, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Spojené státy, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, Spojené státy, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, Spojené státy, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Spojené státy, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Spojené státy, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109-0752
- University Of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Spojené státy, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Spojené státy, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Spojené státy, 48202
- Henry Ford Hospital
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Detroit, Michigan, Spojené státy, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Spojené státy, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, Spojené státy, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, Spojené státy, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, Spojené státy, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, Spojené státy, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Spojené státy, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Spojené státy, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Spojené státy, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Spojené státy, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Spojené státy, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Spojené státy, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Spojené státy, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, Spojené státy, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Spojené státy, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Spojené státy, 87131
- MBCCOP - University of New Mexico HSC
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New York
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New York, New York, Spojené státy, 10032
- Herbert Irving Comprehensive Cancer Center
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North Carolina
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Winston-Salem, North Carolina, Spojené státy, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Spojené státy, 45219
- Barrett Cancer Center, The University Hospital
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Cincinnati, Ohio, Spojené státy, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Spojené státy, 43206
- CCOP - Columbus
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Dayton, Ohio, Spojené státy, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Spojené státy, 45429
- CCOP - Dayton
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Toledo, Ohio, Spojené státy, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Spojené státy, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Spojené státy, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Spojené státy, 97213
- CCOP - Columbia River Program
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Portland, Oregon, Spojené státy, 97201-3098
- Oregon Cancer Center
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South Carolina
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Greenville, South Carolina, Spojené státy, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Spojené státy, 29303
- CCOP - Upstate Carolina
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Texas
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Dallas, Texas, Spojené státy, 75216
- Veterans Affairs Medical Center - Dallas
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Fort Sam Houston, Texas, Spojené státy, 78234
- Brooke Army Medical Center
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Galveston, Texas, Spojené státy, 77555-0209
- University of Texas Medical Branch
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Lubbock, Texas, Spojené státy, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, Spojené státy, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Spojené státy, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, Spojené státy, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Spojené státy, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Spojené státy, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Spojené státy, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Spojené státy, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Spojené státy, 98104
- Swedish Cancer Institute
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Seattle, Washington, Spojené státy, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, Spojené státy, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, Spojené státy, 98405-0986
- CCOP - Northwest
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: paclitaxel 3 cycles
paclitaxel given for 3 cycles
|
135 mg/m2 IV every 28 days
Ostatní jména:
|
|
Experimentální: paclitaxel for 12 cycles
paclitaxel given for 12 cycles
|
135 mg/m2 IV every 28 days
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
progression-free survival
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Maurie Markman, MD, The Cleveland Clinic
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Novotvary podle histologického typu
- Novotvary
- Urogenitální novotvary
- Novotvary podle místa
- Karcinom
- Novotvary, žlázové a epiteliální
- Genitální novotvary, ženy
- Onemocnění endokrinního systému
- Onemocnění vaječníků
- Adnexální onemocnění
- Gonadální poruchy
- Novotvary endokrinních žláz
- Onemocnění vejcovodů
- Novotvary vaječníků
- Novotvary vejcovodů
- Karcinom, ovariální epiteliální
- Molekulární mechanismy farmakologického působení
- Antineoplastická činidla
- Tubulinové modulátory
- Antimitotické látky
- Modulátory mitózy
- Antineoplastické látky, fytogenní
- Paklitaxel
Další identifikační čísla studie
- CDR0000065875
- U10CA032102 (Grant/smlouva NIH USA)
- SWOG-S9701 (Jiný identifikátor: SWOG)
- GOG-178 (Jiný identifikátor: GOG)
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