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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CLB-99901 | |||
| GUMC-00192 | |||
| CDR0000067827 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating men who have stage IV prostate cancer that has not responded to hormone therapy.
OBJECTIVES:
OUTLINE: Patients receive nitrocamptothecin orally daily for 5 consecutive days each week for 3 consecutive weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until evidence of progression or relapse for a maximum of 2 years from the date of registration.
PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study over 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nitrocamptothecin | Experimental | Patients receive nitrocamptothecin orally daily for 5 consecutive days each week for 3 consecutive weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until evidence of progression or relapse for a maximum of 2 years from the date of registration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nitrocamptothecin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| median time to disease and PSA progression | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Up to 2 years |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Edward P. Gelmann, MD | Lombardi Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center - Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of California San Diego Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15464920 | Result | Amin A, Halabi S, Gelmann EP, Stadler W, Vogelzang N, Small E. 9-Nitrocamptothecin as second line chemotherapy for men with progressive, metastatic, hormone refractory prostate cancer: Results of the CALGB 99901. Urol Oncol. 2004 Sep-Oct;22(5):398-403. doi: 10.1016/j.urolonc.2004.05.002. |
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| La Jolla |
| California |
| 92093-0658 |
| United States |
| UCSF Cancer Center and Cancer Research Institute | San Francisco | California | 94115-0128 | United States |
| Veterans Affairs Medical Center - San Francisco | San Francisco | California | 94121 | United States |
| CCOP - Christiana Care Health Services | Wilmington | Delaware | 19899 | United States |
| Lombardi Cancer Center, Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| University of Illinois at Chicago Health Sciences Center | Chicago | Illinois | 60612 | United States |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | 60612 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637 | United States |
| Hematology Oncology Associates of the Quad Cities | Bettendorf | Iowa | 52722 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Veterans Affairs Medical Center - Togus | Togus | Maine | 04330 | United States |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | 21201 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | 55417 | United States |
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia | Missouri | 65201 | United States |
| Ellis Fischel Cancer Center - Columbia | Columbia | Missouri | 65203 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-3330 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Veterans Affairs Medical Center - Buffalo | Buffalo | New York | 14215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| New York Presbyterian Hospital - Cornell Campus | New York | New York | 10021 | United States |
| Mount Sinai Medical Center, NY | New York | New York | 10029 | United States |
| State University of New York - Upstate Medical University | Syracuse | New York | 13210 | United States |
| Veterans Affairs Medical Center - Syracuse | Syracuse | New York | 13210 | United States |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | 13217 | United States |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | United States |
| Veterans Affairs Medical Center - Durham | Durham | North Carolina | 27705 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | 27104-4241 | United States |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157-1082 | United States |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | 43210 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| University of Tennessee, Memphis Cancer Center | Memphis | Tennessee | 38103 | United States |
| Veterans Affairs Medical Center - Memphis | Memphis | Tennessee | 38104 | United States |
| CCOP - Southwestern Vermont Regional Cancer Center | Bennington | Vermont | 05201 | United States |
| Vermont Cancer Center | Burlington | Vermont | 05401-3498 | United States |
| Veterans Affairs Medical Center - White River Junction | White River Junction | Vermont | 05009 | United States |
| Veterans Affairs Medical Center - Richmond | Richmond | Virginia | 23249 | United States |
| MBCCOP - Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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