Spots Global Cancer Trial Database for S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
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Trial Identification
Brief Title: S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
Official Title: A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Urothelial Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin With Molecular Correlates
Study ID: NCT00045630
Study Description
Brief Summary: 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 and decrease the need for surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by observation or surgery to remove the bladder (cystectomy) in treating patients who have stage II or stage III cancer of the urothelium.
Detailed Description: OBJECTIVES: * Determine the pathologic complete response of patients with stage II or III transitional cell cancer of the urothelium treated with neoadjuvant gemcitabine, paclitaxel, and carboplatin followed by observation or immediate cystectomy. * Determine, preliminarily, if molecular markers predict response, survival, and tumor recurrence in patients treated with these regimens. * Determine recurrence rates and cystectomy-free survival of patients who choose observation after an initial response to neoadjuvant chemotherapy. * Compare the survival of patients treated with neoadjuvant chemotherapy followed by cystectomy vs observation. * Determine the feasibility, tolerability, and toxicity of these regimens in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks after completion of neoadjuvant chemotherapy, patients undergo a third transurethral resection of bladder tumor. Patients with T0 disease after neoadjuvant chemotherapy may choose to undergo observation. These patients undergo cystoscopies with biopsies every 3 months for 1 year, every 4 months for 1 year, and then every 6 months until disease progression. Patients with T1 disease or greater after neoadjuvant chemotherapy undergo immediate cystectomy. Patients with T0 disease may also choose this option. Patients undergoing immediate cystectomy are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study within 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Center at Providence Alaska Medical Center, Anchorage, Alaska, United States
Banner Thunderbird Medical Center, Glendale, Arizona, United States
Banner Desert Medical Center, Mesa, Arizona, United States
Banner Baywood Medical Center, Mesa, Arizona, United States
Banner Good Samaritan Medical Center, Phoenix, Arizona, United States
CCOP - Western Regional, Arizona, Phoenix, Arizona, United States
Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado, United States
Shaw Cancer Center at Vail Valley Medical Center, Edwards, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
McKee Medical Center, Loveland, Colorado, United States
Montrose Memorial Hospital Cancer Center, Montrose, Colorado, United States
Saint Anthony's Hospital at Saint Anthony's Health Center, Alton, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Good Samaritan Regional Health Center, Mt. Vernon, Illinois, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States
Southwest Medical Center, Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States
Christus Schumpert Cancer Treatment Center, Shreveport, Louisiana, United States
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States
Bay Regional Medical Center, Bay City, Michigan, United States
Mecosta County Medical Center, Big Rapids, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States
Spectrum Health Hospital - Butterworth Campus, Grand Rapids, Michigan, United States
Metropolitan Hospital, Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Holland Community Hospital, Holland, Michigan, United States
Foote Hospital, Jackson, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
Hackley Hospital, Muskegon, Michigan, United States
Seton Cancer Institute - Saginaw, Saginaw, Michigan, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Gape Girardeau, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, St. Louis, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
St. Vincent Healthcare, Billings, Montana, United States
Deaconess Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
St. James Community Hospital, Butte, Montana, United States
Big Sky Oncology, Great Falls, Montana, United States
Sletten Regional Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
, Great Falls, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Center, Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital, Kearney, Nebraska, United States
Adirondack Cancer Care - Glens Falls, Glens Falls, New York, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Wayne Radiation Oncology, Goldsboro, North Carolina, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Wilson Medical Center, Wilson, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center, Winston-Salem, North Carolina, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center, Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland, Oregon, United States
Legacy Meridian Park Hospital, Tualatin, Oregon, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
University of Tennessee Cancer Institute - Medical Center, Memphis, Tennessee, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
American Fork Hospital, American Fork, Utah, United States
Logan Regional Hospital, Logan, Utah, United States
Cottonwood Hospital Medical Center, Murray, Utah, United States
McKay-Dee Hospital Center, Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo, Provo, Utah, United States
Dixie Regional Medical Center - East Campus, Saint George, Utah, United States
Utah Cancer Specialists at UCS Cancer Center, Salt Lake City, Utah, United States
Latter Day Saints Hospital, Salt Lake City, Utah, United States
Danville Regional Medical Center, Danville, Virginia, United States
St. Joseph Cancer Center, Bellingham, Washington, United States
Olympic Hematology and Oncology, Bremerton, Washington, United States
Skagit Valley Hospital Cancer Care Center, Mt. Vernon, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Harborview Medical Center, Seattle, Washington, United States
Minor and James Medical, PLLC, Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States
Polyclinic First Hill, Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States
North Puget Oncology at United General Hospital, Sedro-Wooley, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States
Wenatchee Valley Medical Center, Wenatchee, Washington, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States
Contact Details
Name: Primo N. Lara, MD
Affiliation: University of California, Davis
Role: STUDY_CHAIR
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