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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.

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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