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| ID | Type | Description | Link |
|---|---|---|---|
| Pfizer2005-0958 |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Prostate cancer is prevalent in the United States, with approximately 230,110 new cases and 29,900 deaths in 2004. Approximately 30% of new cases will be clinical stage T3 when they are diagnosed. This is a stage in which there is high probability that the cancer has spread beyond the prostate gland itself, making it much more difficult to treat. In these cases, when surgery is done by itself and the prostate is removed, it is still very likely that some cancer that has spread beyond the prostate remains and will get worse. Radiation applied to the prostate also does not work well on tumors that have spread beyond the prostate. Even surgery and radiation combined have not eliminated the problems caused by prostate cancer that has spread into the tissue outside the prostate itself.
New treatments are needed to deal with prostate cancer at this more serious stage. Study doctors believe that it might be possible to shrink the prostate cancer using a new drug called SUO11248 or Sunitinib. After the patients take the drug, study doctors believe the cancer will shrink back to within the prostate, and they can then surgically remove the prostate and all the cancer. Patients on this study also will be given increasing doses of Sunitinib to find out how much of the drug can be given safely.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 5 Subjects will receive 37.5 mg/d of the study drug for 1 week. |
|
| Group B | Experimental | 5 Subjects will receive 50.0 mg/d of the study drug for 1 week. |
|
| Group C | Experimental | 5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks. |
|
| Group D | Experimental | 5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks. |
|
| Group E | Experimental | 5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SU011248 | Drug | 5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effects of SU011248 by histological examination of prostate tumors following radical prostatectomy. | 24 months | |
| To determine maximum tolerable dose of SU011248 when administered with prostate cancer prior to radical prostatectomy. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effects of SUO11248 on tumoral phospho VEGF/PDGF, receptor TK pathways, microvessel density, antiangiogenic activities and serum PSA levels. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arie Belldegrun, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles, Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12953083 | Background | Weir HK, Thun MJ, Hankey BF, Ries LA, Howe HL, Wingo PA, Jemal A, Ward E, Anderson RN, Edwards BK. Annual report to the nation on the status of cancer, 1975-2000, featuring the uses of surveillance data for cancer prevention and control. J Natl Cancer Inst. 2003 Sep 3;95(17):1276-99. doi: 10.1093/jnci/djg040. | |
| Background | Cancer Facts and Figures 2004. American Cancer Society, 2004. | ||
| 10235151 |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Not provided
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| SU011248 |
| Drug |
5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks. |
|
| SU011248 | Drug | 5 Subjects will receive 50.0 mg/d of the study drug for 1 week. |
|
| SU011248 | Drug | 5 Subjects will receive 37.5 mg/d of the study drug for 1 week. |
|
| SU011248 | Drug | 5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks. |
|
| Background |
| Pound CR, Partin AW, Eisenberger MA, Chan DW, Pearson JD, Walsh PC. Natural history of progression after PSA elevation following radical prostatectomy. JAMA. 1999 May 5;281(17):1591-7. doi: 10.1001/jama.281.17.1591. |
| 15310996 | Background | Roehl KA, Han M, Ramos CG, Antenor JA, Catalona WJ. Cancer progression and survival rates following anatomical radical retropubic prostatectomy in 3,478 consecutive patients: long-term results. J Urol. 2004 Sep;172(3):910-4. doi: 10.1097/01.ju.0000134888.22332.bb. |
| 15069310 | Background | Kasamon KM, Dawson NA. Update on hormone-refractory prostate cancer. Curr Opin Urol. 2004 May;14(3):185-93. doi: 10.1097/00042307-200405000-00008. |
| 1374065 | Background | Zagars GK. Prostate-specific antigen as a prognostic factor for prostate cancer treated by external beam radiotherapy. Int J Radiat Oncol Biol Phys. 1992;23(1):47-53. doi: 10.1016/0360-3016(92)90542-p. |
| 2468796 | Background | Stamey TA, Kabalin JN, Ferrari M. Prostate specific antigen in the diagnosis and treatment of adenocarcinoma of the prostate. III. Radiation treated patients. J Urol. 1989 May;141(5):1084-7. doi: 10.1016/s0022-5347(17)41176-1. |
| 2473221 | Background | Kabalin JN, Hodge KK, McNeal JE, Freiha FS, Stamey TA. Identification of residual cancer in the prostate following radiation therapy: role of transrectal ultrasound guided biopsy and prostate specific antigen. J Urol. 1989 Aug;142(2 Pt 1):326-31. doi: 10.1016/s0022-5347(17)38746-3. |
| 3113715 | Background | Zagars GK, von Eschenbach AC, Johnson DE, Oswald MJ. Stage C adenocarcinoma of the prostate. An analysis of 551 patients treated with external beam radiation. Cancer. 1987 Oct 1;60(7):1489-99. doi: 10.1002/1097-0142(19871001)60:73.0.co;2-9. |
| 2219577 | Background | Bagshaw MA, Cox RS, Ramback JE. Radiation therapy for localized prostate cancer. Justification by long-term follow-up. Urol Clin North Am. 1990 Nov;17(4):787-802. |
| 8490929 | Background | Wheeler JA, Zagars GK, Ayala AG. Dedifferentiation of locally recurrent prostate cancer after radiation therapy. Evidence for tumor progression. Cancer. 1993 Jun 1;71(11):3783-7. doi: 10.1002/1097-0142(19930601)71:113.0.co;2-x. |
| 2337747 | Background | Cumming JA, Ritchie AW, Goodman CM, McIntyre MA, Chisholm GD. De-differentiation with time in prostate cancer and the influence of treatment on the course of the disease. Br J Urol. 1990 Mar;65(3):271-4. doi: 10.1111/j.1464-410x.1990.tb14725.x. |
| Background | Stamey TA and McNeal JE: Adenocarcinoma of the prostate. In Campbell's Urology 6th edition (Walsh PC, Retik AB, Stamey MA and Vaughan ED, eds), W.B. Saunders Co., pp 1159-1221, 1992. |
| 2342177 | Background | Stamey TA, Villers AA, McNeal JE, Link PC, Freiha FS. Positive surgical margins at radical prostatectomy: importance of the apical dissection. J Urol. 1990 Jun;143(6):1166-72; discussion 1172-3. doi: 10.1016/s0022-5347(17)40216-3. |
| 1635129 | Background | Rosen MA, Goldstone L, Lapin S, Wheeler T, Scardino PT. Frequency and location of extracapsular extension and positive surgical margins in radical prostatectomy specimens. J Urol. 1992 Aug;148(2 Pt 1):331-7. doi: 10.1016/s0022-5347(17)36587-4. |
| 2304166 | Background | Catalona WJ, Bigg SW. Nerve-sparing radical prostatectomy: evaluation of results after 250 patients. J Urol. 1990 Mar;143(3):538-43; discussion 544. doi: 10.1016/s0022-5347(17)40013-9. |
| 1712655 | Background | Stein A, deKernion JB, Dorey F. Prostatic specific antigen related to clinical status 1 to 14 years after radical retropubic prostatectomy. Br J Urol. 1991 Jun;67(6):626-31. doi: 10.1111/j.1464-410x.1991.tb15228.x. |
| 7679755 | Background | Frazier HA, Robertson JE, Humphrey PA, Paulson DF. Is prostate specific antigen of clinical importance in evaluating outcome after radical prostatectomy. J Urol. 1993 Mar;149(3):516-8. doi: 10.1016/s0022-5347(17)36132-3. |
| Background | R Motzer, B Rini, M Michaelson, B Redman, G Hudes, G Wilding, R Bukowski, D George, S Kim, I Chen, C Baum and the SU11248 Study Group: Phase 2 Trials of SU11248 Show Antitumor Activity in Second-Line Therapy for Patients with Metastatic Renal Cell Carcinoma (RCC). ASCO, 2005. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |