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| ID | Type | Description | Link |
|---|---|---|---|
| SWOG-S0336 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with unresectable locally advanced or metastatic colorectal cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression and then every 3 months until 1 year after study entry and then every 6 months until 3 years after study entry.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 4-10 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| romidepsin | Drug |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed colorectal cancer meeting 1 of the following criteria:
Measurable disease
Previously treated with at least 1, but no more than 2, prior chemotherapy regimens for unresectable locally advanced or metastatic disease
No known brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Robert P. Whitehead, MD | University of Texas |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBCCOP - Gulf Coast | Mobile | Alabama | 36607 | United States | ||
| CCOP - Western Regional, Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18941712 | Result | Whitehead RP, Rankin C, Hoff PM, Gold PJ, Billingsley KG, Chapman RA, Wong L, Ward JH, Abbruzzese JL, Blanke CD. Phase II trial of romidepsin (NSC-630176) in previously treated colorectal cancer patients with advanced disease: a Southwest Oncology Group study (S0336). Invest New Drugs. 2009 Oct;27(5):469-75. doi: 10.1007/s10637-008-9190-8. Epub 2008 Oct 22. | |
| Result | Whitehead RP, McCoy S, Wollner IS, et al.: Phase II trial of depsipeptide (NSC-630176) in colorectal cancer patients who have received either one or two prior chemotherapy regimens for metastatic or locally advanced, unresectable disease: a Southwest Oncology Group study. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-255, 2006. |
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| 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 |
| Veterans Affairs Medical Center - Loma Linda (Pettis) | Loma Linda | California | 92357 | 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 |
| 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 | 66160-7353 | 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 | 48109-0948 | 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 |
| 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 |
| Veterans Affairs Medical Center - Memphis | Memphis | Tennessee | 38104 | United States |
| Harrington Cancer Center | 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 |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | 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 |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C087123 | romidepsin |
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