Current UW/SCCA GU Oncology Clinical Trials Updated 01/25/2010

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Alexandrina Roberts
5 years ago
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1 Neoadjuvant Non-Metastatic Current UW/SCCA GU Oncology Clinical Trials Gleason Stage PSA Design Type Route Active surveillance PASS 3 Active Surveillance for pts w/ Active T1 2 NA Visit Seattle q6 months local disease Surveillance Repeat biopsy at intervals Diet 8 3+3,3+4 T1-2 <20 ADT + IMC A T2c 3 >20 Sorafenib T2b - 3 >20 Neoadjuvant Abiraterone T1 3 Rand to 6 wk dietary intervention (calorie restrict w/ nutritionist) or standard Open-label Caso + Zolo + IMC-A12 x3 mos Open-label Sorafenib preprostectomy~6 wks 3 mos Abiraterone/LHRH vs. LHRH followed by 3 mos Abiraterone/LHRH + prostatectomy Anti IGF 1R Monoclonal Antibody Molecular Targeted Therapy Neo AS NA IM// IM/ BMI > 25 No diabetes 2 fasting visits to FHCRC Weekly nutritionist appts (in person or phone) Gleason 8 10 or T2c or T3 or PSA >20 or Kattan Recurrence >50% Pre-tx biopsy No insulin-dep diabetes Stage T2b or T3 or PSA >20 or overall Gleason 8 10 RP planned as Tx, no prior PCa therapy Minimum 3 positive core biopsies Pending RAD Neo Open label LHRH and Neo and 3 mnths LHRH/Abiraterone Abiratone & 7 10 T1 3 Abiraterone for intermediate IM/ Concurrent AS prior & 8 weeks during rad Radiation & high risk disease Pre-tx biopsy required Neo Provenge 11 Pending Start-up 3/2010 For more information, please contact: Page 1 of 1

2 Neoadjuvant Non-Metastatic Current UW/SCCA GU Oncology Clinical Trials Gleason Stage PSA Design Type Route Rising PSA following rad prostatectomy > 6 wks post-prostatectomy Perf Status: 0 1 pt3no/nx >0.1 Phase 3 trial, short-term RTOG 0534 No Androgen deprivation postprost and/or > 6 mnths prior Radiotherapy 10 < 8 or and androgen dep w/ pelvic Salvage XRT IM pt2no/nx <2.0 node or prost only RT Pts randomized to pros bed RT alone or pros bed RT + HDT, or pelvic lymph node + pros bed RT + HDT Biochemical Relapse Non-Metastatic Min PSA Design Type Route LHRH agonist enrolling IAS 9 Phase 2 intermittent none & antiandrogen IM & androgen suppression SCORE none Intermit or continuous ADT. At 10th month will have 1month of T- gel Pts about ready to start ADT. No other cancer tx. Prior ADT okay if off for >6mos and T normal Must agree to cognitive function testing throughout the study At Month 10 pts are Randomized to active T-Gel or placebo. Coordinator may go to pt location for testing if necessary. For more information, please contact: Page 2 of 2

3 HRPC Non-Metastatic Astra Zeneca ZD Asx Only X Prior Chemo Biphos Min PSA Design Type Route Phase 3 randomized, double-blind, placebo controlled ETA Receptor Antagonist PSA must be >1.2 in pts with RP & >5 in all other pts HRPC Metastatic 1 st Line Abiraterone Cougar Asx Only very mild Biphos Okay if started prior to day 1 Min PSA Design Type Route NA Taxotere +/- GM-CSF 1 X 5.0 Tokai X X Doxetaxel 7 Duke Microarray Rising (2) & >5 2 rises above nadir Phase 3 randomized, placebo control 1:1 Phase 2 intermittent chemo +/- maintenance GM- CSF Phase 1b/2 open label First in man Phase 2 study to see if microarray eval will predict chemo response Adrenal androgen inhibitor Chemo Immuno tx Adrenal androgen inhibitor & anti-androgen Taxotere /SC Mild symptoms or asymptomatic No pain meds, opiates or radiation No prior MDV 3100, HE 3235, A12, or Keto Late enrollment option for pts who have received <3 cycles Taxotere, if q3wk schedule & dose between 60-75mg/m2 No prior MDV3100, TAK-700, Keto, abiraterone, or chemo No protein pump/h2 blockers, statins, lasix, Coumadin, TCA s Option for bone biopsy coordinator for availability Requires bone or soft-tissue biopsy (bone biopsy done at HMC only) For more information, please contact: Page 3 of 3

4 HRPC Metastatic 1 st Line Docetaxel +/- Dasatinib 1 BMS Asx Only Biphos X Min PSA Design Type Route Rising & >2 SWOG Docetaxel +/- X X 5.0 Atrasentan 4 Phase 3 randomized, double-blind, placebo controlled Randomized, double-blind Taxotere +/- Atrasentan SRC Tyrosine kinase inhibitor Chemo targeted / All pts receive Taxotere/prednisone No significant CV disease -- EF>40% No prior chemo except Extramustine Still enrolling Requires positive bone scan HRPC Metastatic 2 nd Line/beyond PHA Nerviano Biphos PSA Design Type Route X X NA Phase 2 Open Label for Taxotere failures OGX X X NA Phase 2 Open Label Medivation MDV No more than 2 prior, 1 Taxotere Rising (3) > 2.0 Phase 3 Randomized, Double-Blind, Placebo control Aurora Kinase Inhibitor Antisense, Oligonucleotide to HSP27 Androgen Receptor Antagonist Must have failed Taxotere Pts randomized to either 6- hr or 24-hr infusion Check w/ Coordinator for availability Must have bladder, prostate, breast, lung or ovarian cancer Coordinator for availability No prior MDV3100 No prior Provenge, Abiraterone, TAK-700, TAK- 683, TAK No progression on Keto No hx of seizures EF > 45% For more information, please contact: Page 4 of 4

5 HRPC Metastatic 2 nd Line/beyond Nilutamide or Dasatinib X X Duke Genomic 7 HE Hollis-Eden Biphos PSA Design Type Route Rising (2) > 2.0 X > 2.0 Phase 2, Open Label, Biopsy will determine Tx Phase 1/ 2 Open Label, 2 nd Line for Taxotere Failure Drug selected by AR expression Androgen Receptor Antagonist No prior Tx with Nilutamide or Dasatinib Requires tumor biopsy to determine AR expression and Tx. (bone biopsy done only at HMC) Optional participation in ACRIN PET Must have failed at least 1 taxane regimen; or be chemo naive Progressive disease despite androgen therapy Serum T < 50ng/ml Coordinator for availability Non-Treatment Imaging Metastatic Mets PET 5 Hxt XRT >4 wks prior ACRIN NA+18F PET 7 X NA PSA Design Type NA Non-Tx, nonintervention, PET scan, survey, diary Non-Tx, nonintervention, PET scan, survey, diary Imaging Imaging >3 bone mets Pre-AS or pre-chemo A1 (T <20) 4 6 wk anti-androgen washout Biphos start >4 wk prior 2 scans (BL & 6-12 wk later) Tues, Wed, Thurs afternoons only Must be enrolled in Nilutimide vs. Dasatanib (Duke Genomic) trial For more information, please contact: Page 5 of 5

6 Stage TCC Urothelium Metastatic Gem/Cis +/- Cetuximab 7 Asx Only Prior neoadjuvant or adjuvant chemo ok Docetaxel +/- Zactima 7 X BI OGX Prior neoadjuvant or adjuvant chemo ok X Design Type Route Phase 2 randomized open-label Phase 2 randomized Docetaxel +/- Zactima Phase 2 openlabel, sig III or bladder, ureters or renal pelvis Phase 2 Open Label Chemo +/- EGFR monoclonal antibody VEGFR inhibitor, small molecule Small molecule, Plk 1 inhibitor Antisense, Oligonucleotide to HSP27 Must have T4bN0 or an T N2-3 disease No prior EGFR tx Prior chemo w/ platinum salt 1 3 prior systemic chemo or investigational tx regimens No prior tx with VEGF-axis agent pending startup 3/2010 ECOG 2 or less No hx QT prolongation Must have bladder, prostate, breast, lung or ovarian cancer Coordinator on availability For more information, please contact: Page 6 of 6

CLINICAL TRIALS Open clinical uro-oncology trials in Canada George Rodrigues, MD, Eric Winquist, MD

CLINICAL TRIALS Open clinical uro-oncology trials in Canada George Rodrigues, MD, Eric Winquist, MD Open clinical uro-oncology trials in Canada George Rodrigues, MD, Eric Winquist, MD London Health Sciences Centre, London, Ontario, Canada bladder cancer AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE II