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| ID | Type | Description | Link |
|---|---|---|---|
| S0121 | Other Identifier | SWOG | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy before radiation therapy, and combining chemotherapy with radiation therapy, may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of neoadjuvant gemcitabine, paclitaxel, and carboplatin followed by cisplatin and radiation therapy in treating patients who have locally advanced or recurrent carcinoma (cancer) of the urothelium.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive neoadjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity.
Within 4-8 weeks after the completion of neoadjuvant chemotherapy, patients receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent radiotherapy 5 days a week for 6 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 4 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | *AUC=5 (by modified Calvert formula), IV, over 15 minutes; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days) |
| |
| cisplatin | Drug | 75 mg/m2 (maximum dose 150 mg), IV, rapid infusion; given q 21 days for 2 cycles (1 cycle = 21 days) |
| |
| gemcitabine hydrochloride | Drug | 800 mg/m2, IV, over 30 minutes; given on Days 1 & 8, q 21 days, for a maximum of 3 cycles (1 cycle = 21 days) |
| |
| paclitaxel | Drug | 200 mg/m2, IV, over 3 hours; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days) |
| |
| neoadjuvant therapy | Procedure |
DISEASE CHARACTERISTICS:
Histologically confirmed primary or recurrent invasive carcinoma of the urothelium
Transitional, squamous, or mixed cell subtypes allowed
Primary disease site must be the urinary bladder or urethra
Disease confined to the true pelvis (T2-T4, N0-N3, M0)
Must meet at least 1 of the following criteria:
Measurable or nonmeasurable disease
Evidence of tumor invasion of the muscularis by cystoscopy and biopsy and detailed bladder mapping within the past 56 days
No extrapelvic metastases
Eligible to receive radiotherapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Ulka N. Vaishampayan, MD | Barbara Ann Karmanos Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBCCOP - Gulf Coast | Mobile | Alabama | 36607 | United States | ||
| CCOP - Western Regional, Arizona |
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Neoadjuvant chemotherapy (paclitaxel, carboplatin, and gemcitabine)
| radiation therapy | Radiation | Radiation treatments will be delivered once daily. Treatment will be given 5 days per week at a dose of 180 to 200 cGy per day. All fields will be treated everyday. |
| Phoenix |
| Arizona |
| 85006-2726 |
| United States |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix | Arizona | 85012 | United States |
| Veterans Affairs Medical Center - Tucson | Tucson | Arizona | 85723 | United States |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | 85724 | United States |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Veterans Affairs Medical Center - Little Rock | Little Rock | Arkansas | 72205 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90033 | United States |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | 94553 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609-3305 | United States |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California | 92868 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | 95403 | United States |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Aurora | Colorado | 80010 | United States |
| Veterans Affairs Medical Center - Denver | Denver | Colorado | 80220 | United States |
| MBCCOP - Howard University Cancer Center | Washington D.C. | District of Columbia | 20060 | United States |
| Veterans Affairs Medical Center - Tampa (Haley) | Tampa | Florida | 33612 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342-1701 | United States |
| MBCCOP - Hawaii | Honolulu | Hawaii | 96813 | United States |
| MBCCOP - University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Veterans Affairs Medical Center - Chicago Westside Hospital | Chicago | Illinois | 60612 | United States |
| CCOP - Central Illinois | Decatur | Illinois | 62526 | United States |
| Veterans Affairs Medical Center - Hines | Hines | Illinois | 60141 | United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153-5500 | United States |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7390 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Veterans Affairs Medical Center - Wichita | Wichita | Kansas | 67218 | United States |
| Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | 40502-2236 | United States |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536-0084 | United States |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans | Louisiana | 70112 | United States |
| Veterans Affairs Medical Center - New Orleans | New Orleans | Louisiana | 70112 | United States |
| Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | 71101-4295 | United States |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport | Louisiana | 71130-3932 | United States |
| Cancer Research Center at Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0946 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Veterans Affairs Medical Center - Detroit | Detroit | Michigan | 48201-1932 | United States |
| Josephine Ford Cancer Center at Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Beaumont | Royal Oak | Michigan | 48073-6769 | United States |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield | Michigan | 48075 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | 39216 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65807 | United States |
| Saint Louis University Cancer Center | St Louis | Missouri | 63110 | United States |
| CCOP - St. Louis-Cape Girardeau | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | 87108-5138 | United States |
| MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | 87131 | United States |
| Western New York Urology Associates | Buffalo | New York | 14220 | United States |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | 10032 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| CCOP - Southeast Cancer Control Consortium | Goldsboro | North Carolina | 27534-9479 | United States |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | 45220-2288 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267-0501 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195-9001 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428-1002 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97201-3098 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| Veterans Affairs Medical Center - Charleston | Charleston | South Carolina | 29401-5799 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| University of Tennessee Cancer Institute at Methodist Central Hospital | Memphis | Tennessee | 38104 | United States |
| Harrington Cancer Center | Amarillo | Texas | 79106 | United States |
| Texas Tech University Health Sciences Center School of Medicine | Amarillo | Texas | 79106 | United States |
| Veterans Affairs Medical Center - Amarillo | Amarillo | Texas | 79106 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234-6200 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0565 | United States |
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4095 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| UMC Southwest Cancer and Research Center | Lubbock | Texas | 79415-3364 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | 78229 | United States |
| Veterans Affairs Medical Center - Temple | Temple | Texas | 76504 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112-5550 | United States |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | 84148 | United States |
| Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk | Virginia | 23510-1115 | United States |
| CCOP - Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| Veterans Affairs Medical Center - Seattle | Seattle | Washington | 98108 | United States |
| Puget Sound Oncology Consortium | Seattle | Washington | 98109 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D014523 | Urethral Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014522 | Urethral Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| D020360 | Neoadjuvant Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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