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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Alabama
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Mobile, Alabama, Stati Uniti, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Stati Uniti, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, Stati Uniti, 85724
- Arizona Cancer Center
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Tucson, Arizona, Stati Uniti, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Stati Uniti, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Stati Uniti, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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La Jolla, California, Stati Uniti, 92037
- Scripps Clinic Cancer Center
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Long Beach, California, Stati Uniti, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Stati Uniti, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Stati Uniti, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Stati Uniti, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, Stati Uniti, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Stati Uniti, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Stati Uniti, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Stati Uniti, 95817
- University of California Davis Medical Center
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Santa Rosa, California, Stati Uniti, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Stati Uniti, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Stati Uniti, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Stati Uniti, 80010
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, Stati Uniti, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Stati Uniti, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96813
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, Stati Uniti, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Stati Uniti, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Decatur, Illinois, Stati Uniti, 62526
- CCOP - Central Illinois
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Hines, Illinois, Stati Uniti, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Stati Uniti, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Stati Uniti, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Stati Uniti, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Stati Uniti, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Stati Uniti, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, Stati Uniti, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, Stati Uniti, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Stati Uniti, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Stati Uniti, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109-0752
- University Of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Stati Uniti, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Stati Uniti, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Hospital
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Detroit, Michigan, Stati Uniti, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Stati Uniti, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, Stati Uniti, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, Stati Uniti, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, Stati Uniti, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, Stati Uniti, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Stati Uniti, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Stati Uniti, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Stati Uniti, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Stati Uniti, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Stati Uniti, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Stati Uniti, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Stati Uniti, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, Stati Uniti, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Stati Uniti, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Stati Uniti, 87131
- MBCCOP - University of New Mexico HSC
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New York
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New York, New York, Stati Uniti, 10032
- Herbert Irving Comprehensive Cancer Center
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North Carolina
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Winston-Salem, North Carolina, Stati Uniti, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- Barrett Cancer Center, The University Hospital
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Cincinnati, Ohio, Stati Uniti, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Stati Uniti, 43206
- CCOP - Columbus
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Dayton, Ohio, Stati Uniti, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Stati Uniti, 45429
- CCOP - Dayton
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Toledo, Ohio, Stati Uniti, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Stati Uniti, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Stati Uniti, 97213
- CCOP - Columbia River Program
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Portland, Oregon, Stati Uniti, 97201-3098
- Oregon Cancer Center
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Stati Uniti, 29303
- CCOP - Upstate Carolina
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Texas
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Dallas, Texas, Stati Uniti, 75216
- Veterans Affairs Medical Center - Dallas
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Fort Sam Houston, Texas, Stati Uniti, 78234
- Brooke Army Medical Center
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Galveston, Texas, Stati Uniti, 77555-0209
- University of Texas Medical Branch
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Lubbock, Texas, Stati Uniti, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, Stati Uniti, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Stati Uniti, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, Stati Uniti, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Stati Uniti, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Stati Uniti, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Stati Uniti, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Stati Uniti, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Stati Uniti, 98104
- Swedish Cancer Institute
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Seattle, Washington, Stati Uniti, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, Stati Uniti, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, Stati Uniti, 98405-0986
- CCOP - Northwest
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: paclitaxel 3 cycles
paclitaxel given for 3 cycles
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135 mg/m2 IV every 28 days
Altri nomi:
|
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Sperimentale: paclitaxel for 12 cycles
paclitaxel given for 12 cycles
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135 mg/m2 IV every 28 days
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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progression-free survival
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Maurie Markman, MD, The Cleveland Clinic
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie urogenitali
- Neoplasie per sede
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie genitali, femmina
- Malattie del sistema endocrino
- Malattie ovariche
- Malattie annessiali
- Disturbi gonadici
- Neoplasie delle ghiandole endocrine
- Malattie delle tube di Falloppio
- Neoplasie ovariche
- Neoplasie delle tube di Falloppio
- Carcinoma, epiteliale ovarico
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, fitogenici
- Paclitaxel
Altri numeri di identificazione dello studio
- CDR0000065875
- U10CA032102 (Sovvenzione/contratto NIH degli Stati Uniti)
- SWOG-S9701 (Altro identificatore: SWOG)
- GOG-178 (Altro identificatore: GOG)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .