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Developmental Therapeutics Clinic (DTC)
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Last Updated: 06/02/16

Publications

Our research team also publishes significant findings in medical journals to share with the medical community. The following is a partial listing of those medical articles.

Randomized phase 2 trial of cyclophosphamide and the oral poly (ADP-ribose) polymerase inhibitor veliparib in patients with recurrent, advanced triple-negative breast cancer
Pubmed abstract dated March 2016. PMID: 26996385.

Phase I Study of Single Agent AZD1775 (MK-1775), a WEE1 Inhibitor, in Patients with Refractory Solid Tumors
Do, K., Wilsker, D., Ji, J., Zlott, J., Freshwater, T., Kinders, R.J., Collins, J., Chen, A.P., Doroshow, J.H., and Kummar, S. Published in final edited form as: J. Clin. Oncol., 2015 May 11. pii: JCO.2014.60.4009.

A Phase 2 Study of Sorafenib in Combination with Cetuximab in EGFR-Expressing, KRAS-Mutated Metastatic Colorectal Cancer
Do, K., Cao, L., Kang, Z., Turkbey, B., Lindenberg, M.L., Larkins, E., Holkova, B., Steinberg, S.M., Raffeld, M., Peer, C.J., Figg, W.D., Eugeni, M., Jacobs, P., Choyke, P., Wright, J.J., Doroshow, J.H., and Kummar, S. Published in final edited form as: Clin. Colorectal Cancer, in press.

Phase I Study of the Heat Shock Protein 90 (Hsp90) Inhibitor Onalespib (AT113387) Administered on a Daily for 2 Consecutive Days per Week Dosing Schedule in Patients with Advanced Solid Tumors
Do, K., Speranza, G., Chang, L.-C., Polley, E.C., Bishop, R., Khin, S., Trepel, J.B., Lee, S., Lee, M.-J., Kinders, R.J., Phillips, L, Collins, J., Antony, R., Chen, A.P., Neckers, L., Doroshow, J.H., and Kummar, S. Published in final edited form as: Invest. New Drugs. 2015 Aug; 33(4):921-30. doi: 10.1007/s10637-015-0255-1.

Biomarker-driven phase 2 study of MK-2206 and selumetinib (AZD6244, ARRY-142886) in patients with colorectal cancer
Do, K., Speranza, G., Bishop, R., Khin, S., Rubinstein, L., Datiles, M., Jeong, W., Eugeni, M., Doyle, A., Kinders, R., Doroshow, J.H., and Kummar, S. Published in final edited form as: Invest. New Drugs. 2015 Jun; 33(3):720-8.doi: 10.1007/s10637-015-0212-z.

Randomized Trial of Oral Cyclophosphamide and Veliparib in High-Grade Serous Ovarian, Primary Peritoneal, or
Fallopian Tube Cancers, or BRCA-Mutant Ovarian Cancer

Kummar, S., Oza, A.M., Fleming, G.F., Sullivan, D.M., Gandara, D.R., Naughton, M.J., Villalona-Calero, M.A., Morgan Jr., R.J., Szabo, P.M. Youn, A., Chen, A.P., Ji, J., Allen, D.E., Lih, C.-J., Mehaffey, M.G., Walsh, W.D., McGregor III, P.M., Steinberg, S.M., Williams, P.M., Kinders, R.J., Conley, B.A., Simon, R.M., and Doroshow, J.H. Published in final edited form as: Clin. Cancer Res. 2015 Apr 1; 21(7):1574-82. doi: 10.1158/1078-0432.CCR-14-2565

GeneMed: An Informatics Hub for the Coordination of Next-Generation Sequencing Studies that Support
Precision Oncology Clinical Trials

Zhao, Y., Polley, E.C,, Li, M.-C., Lih, C.-J., Palmisano, A., Sims, D.J., Rubinstein, L.V., Conley, B.A., Chen, A.P., Williams, P.M., Kummar, S., Doroshow, J.H., and Simon, R.M. Published in final edited form as: Cancer Inform. 2015 Mar 19; 14(Suppl 2):45-55. doi: 10.4137/CIN.S17282.

A Phase I, Pharmacokinetic, and Pharmacodynamic Evaluation of the DNA Methyltransferase Inhibitor 5-Fluoro-2’-deoxycytidine Administered with Tetrahydrouridine
Newman, E.M., Morgan, R.J., Kummar, S., Beumer, J.H., Blanchard, M.S., Ruel, C., El-Khoueiry, A.B., Carroll, M.I., Hou, J.M., Li, C., Lenz, H.-J., Eiseman, J.L., and Doroshow, J.H. Published in final edited form as: Cancer Chemother. Pharmacol., 2015 Mar; 75(3):537-46. doi: 10.1007/s00280-014-2674-7

Application of Molecular Profiling in Clinical Trials for Advanced Metastatic Cancers
Kummar, S., Williams, M., Lih, C.-J., Polley, E.C., Chen, A.P., Rubinstein, L.V., Zhao, Y., Simon, R.M., Conley, B.A., and Doroshow, J.H. Published in final edited form as: J. Natl. Cancer Inst. 2015 Feb 6; 107(4). pii: djv003. doi: 10.1093/jnci/djv003.

Molecular Analysis for Therapy Choice: NCI MATCH
Conley, B.A., and Doroshow, J.H.
Published in final edited form as: Semin. Oncol. 2014 Jun; 41(3):297-9.doi: 10.1053/j.seminoncol.2014.05.002.

Weekly EZN-2208 (PEGylated SN-38) in Combination with Bevacizumab in Patients with Refractory Solid Tumors
Jeong, W., Park, S.R., Rapisarda, A., Fer, N., Kinders, R., Chen, A., Melilo, G., Turkbey, B., Steinberg, S.M., Choyke, P., Doroshow, J.H., and Kummar, S. Published in final edited form as: Invest. New Drugs. 2014 Apr; 32(2):340-6.doi: 10.1007/s10637-013-0048-3

Pilot Trial of EZN-2968, an Antisense Oligonucleotide Inhibitor of Hypoxia-Inducible Factor-1 Alpha (HIF-1α), in Patients
with Refractory Solid Tumors

Jeong, W., Rapisarda, A., Kinders, R., Chen, A., Melilo, G., Turkbey, B., Steinberg, S.M., Choyke, P., Doroshow, J.H., and Kummar, S. Published in final edited form as: Cancer Chemother. Pharmacol. 2014 Feb; 73(2):343-8. doi: 10.1007/s00280-013-2362-z.

Overcoming Resistance to Targeted Anticancer Drugs
Doroshow, J.H.Published in final edited form as: N. Engl. J. Med. 2013 Nov 7; 369(19):1852-3. doi: 10.1056/NEJMe1311325.

Criteria for the Use of Omics-Based Predictors in Clinical Trials
McShane, L.M., Cavenagh, M.M., Lively, T.G., Eberhard, D.A., Bigbee, W.L., Williams, P.M., Mesirov, J.P., Polley, M.C., Kim, K.Y., Tricoli, J.V., Taylor, J.M.G., Shuman, D. J., Simon, R.M., Doroshow, J.H., and Conley, B.A.Published in final edited form as: Nature. 2013 Oct 17;11: 220. doi: 10.1186/1741-7015-11-220

Pharmacologically-Driven Patient Selection for a First-in-Human Phase I Trial of Batracylin in Patients with Advanced
Solid Tumors and Lymphomas

Kummar, S., Gutierrez, M.E., Anderson, L.W., Klecker, Jr., R.W., Chen, A., Murgo, A.J., Doroshow, J.H., and Collins, J.M.Published in final edited form as: Cancer Chemother. Pharmacol. 2013 Oct; 72(4):917-23. doi: 10.1007/s00280-013-2244-4.

Timely Completion of Scientifically-Rigorous Cancer Clinical Trials: An Unfilfilled Priority
Doroshow, J.H.: Published in final edited form as: J. Clin. Oncol. 2013 Sep 20; 31(27):3312-4. doi: 10.1200/JCO.2013.51.3192.

US FDA Approved Oral Kinase Inhibitors for the Treatment of Malignancies
Woondong Jeong, James H. Doroshow, Shivaani Kummar
Curr Probl Cancer. Author manuscript; available in PMC 2014 May 1. Published in final edited form as: Curr Probl Cancer. 2013 May-Jun; 37(3): 110-144.doi: 10.1016/j.currproblcancer.2013.06.001

Cediranib for Metastatic Alveolar Soft Part Sarcoma
Shivaani Kummar, Deborah Allen, Anne Monks, Eric C. Polley, Curtis D. Hose, S. Percy Ivy, Ismail B. Turkbey, Scott Lawrence, Robert J. Kinders, Peter Choyke, Richard Simon, Seth M. Steinberg, James H. Doroshow, Lee Helman
J Clin Oncol. 2013 June 20; 31(18): 2296-2302. Published online 2013 April 29.
doi: 10.1200/JCO.2012.47.4288

A Multi-histology Trial of Fostamatinib in Patients with Advanced Colorectal, Non-Small Cell Lung, Head and Neck, Thyroid, and
Renal Cell Carcinomas, and Pheochromocytomas

Park, S.R., Speranza, G., Piekarz, R., Wright, J.J., Kinders, R.J., Wang, L., Pfister, T., Trepel, J.B., Lee, M.-J., Alarcon, S., Steinberg, S.M., Collins, J., Doroshow, J.H., and Kummar, S Published in final edited form as: Cancer Chemother. Pharmacol. 2013 Apr; 71(4):981-90. doi: 10.1007/s00280-013-2091-3.

First-in-Human Phase 0 Trial of Oral 5-iodo-2-pyrimidinone-2'-deoxyribose (IPdR) in Patients with Advanced Malignancies
Shivaani Kummar, Larry Anderson, Kimberly Hill, Eva Majerova, Deborah Allen, Yvonne Horneffer, S. Percy Ivy, Larry Rubinstein, Pamela Harris, James H. Doroshow, Jerry M. Collins
Clin Cancer Res. Author manuscript; available in PMC 2014 April 1.Published in final edited form as: Clin Cancer Res. 2013 April 1; 19(7): 1852-1857. Published online 2013 February 12.
doi: 10.1158/1078-0432.CCR-12-3118

Safety and Feasibility of Targeted Agent Combinations in Solid Tumours
Park, S.R., Davis-Millin, M., Doroshow, J.H., and Kummar, S. Published in final edited form as: Nature Rev. Clin. Oncol. 2013 Mar; 10(3):154-68. doi: 10.1038/nrclinonc.2012.245.

Development and Validation of an Immunoassay for Quantification of Topoisomerase I in Solid Tumor Tissues
Thomas D. Pfister, Melinda Hollingshead, Robert J. Kinders, Yiping Zhang, Yvonne A. Evrard, Jiuping Ji, Sonny A. Khin, Suzanne Borgel, Howard Stotler, John Carter, Raymond Divelbiss, Shivaani Kummar, Yves Pommier, Ralph E. Parchment, Joseph E. Tomaszewski, James H. Doroshow
PLoS One. 2012; 7(12): e50494. Published online 2012 December 28.
doi: 10.1371/journal.pone.0050494

The Promise of Antibody-Drug Conjugates
Teicher, B.A., and Doroshow, J.H.: Published in final edited form as: New Engl. J. Med. 2012 Nov 8; 367(19):1847-8. doi: 10.1056/NEJMe1211736

A Phase I Study of Veliparib in Combination with Metronomic Cyclophosphamide in Adults with Refractory Solid Tumors
and Lymphomas

Shivaani Kummar, Jiuping Ji, Robert Morgan, Heinz-Josef Lenz, Shannon L. Puhalla, Chandra P. Belani, David R. Gandara, Deborah Allen, Brian Kiesel, Jan H. Beumer, Edward M. Newman, Larry Rubinstein, Alice Chen, Yiping Zhang, Lihua Wang, Robert J. Kinders, Ralph E. Parchment, Joseph E. Tomaszewski, James H. Doroshow
Clin Cancer Res. Author manuscript; available in PMC 2013 March 15. Published in final edited form as: Clin Cancer Res. 2012 March 15; 18(6): 1726-1734. Published online 2012 February 3.
doi: 10.1158/1078-0432.CCR-11-2821

Phase I Study of the Synthetic Triterpenoid, 2-Cyano-3, 12-Dioxoolean-1, 9-Dien-28-Oic Acid (CDDO) in Advanced Solid Tumors.
Speranza, G., Gutierrez, M.E., Kummar, S., Strong, J.M., Parker, R.J., Collins, J., Yunkai, Y., Cao, L., Murgo, A.J., Doroshow, J.H., and Chen, A. Published in final edited form as: Cancer Chemother. Pharmacol. 2012 Feb; 69(2):431-8. doi: 10.1007/s00280-011-1712-y

Poly(ADP-ribose) polymerase inhibition enhances p53-dependent and -independent DNA damage responses induced by
DNA damaging agent

Diana Nguyen, Maria Zajac-Kaye, Larry Rubinstein, Donna Voeller, Joseph E Tomaszewski, Shivaani Kummar, Alice P Chen, Yves Pommier, James H Doroshow, Sherry X Yang
Cell Cycle. 2011 December 1; 10(23): 4074-4082. Published online 2011 December 1.doi: 10.4161/cc.10.23.18170

Modeling Pharmacodynamic Response to the Poly(ADP-Ribose) Polymerase Inhibitor ABT-888 in Human Peripheral
Blood Mononuclear Cells

Jiuping Ji, Robert J. Kinders, Yiping Zhang, Larry Rubinstein, Shivaani Kummar, Ralph E. Parchment, Joseph E. Tomaszewski, James H. Doroshow PLoS One. 2011; 6(10): e26152. Published online 2011 October 10.
doi: 10.1371/journal.pone.0026152

Early tumor progression associated with enhanced EGFR signaling with bortezomib, cetuximab, and radiotherapy for
head and neck cancer

Athanassios Argiris, Austin G. Duffy, Shivaani Kummar, Nicole L. Simone, Yoshio Arai, Seungwon W. Kim, Susan. F. Rudy, Vishnu. R. Kannabiran, Xinping Yang, Minyoung Jang, Zhong Chen, Nanette Suksta, Theresa Cooley-Zgela, Susmita G. Ramanand, Aarif Ahsan, Mukesh. K. Nyati, John J. Wright, Carter Van Waes
Clin Cancer Res. Author manuscript; available in PMC 2012 September 1. Published in final edited form as: Clin Cancer Res. 2011 September 1; 17(17): 5755-5764. Published online 2011 July 12.doi: 10.1158/1078-0432.CCR-11-0861

Phase I Study of PARP Inhibitor ABT-888 in Combination with Topotecan in Adults with Refractory Solid Tumors and Lymphomas
Kummar, S., Chen, A., Ji, J., Zhang, Y., Reid, J.M., Ames, M., Jia, L., Weil, M., Speranza, G., Murgo, A.J., Kinders, R., Wang, L., Parchment, R.E., Carter, J., Stotler, H., Rubinstein, L., Hollingshead, M., Melillo, G., Pommier, Y., Bonner, W., Tomaszewski, J.E., and Doroshow, J.H. Published in final edited form as: Cancer Res. 2011 Sep 1; doi: 10.1158/0008-5472.CAN-11-1227

Opportunities and Challenges in the Development of Experimental Drug Combinations for Cancer
Humphrey, R.W., Brockway-Lunardi, L.M., Bonk, D.T., Dohoney, K.M., Doroshow, J.H., Meech, S.J., Ratain, M.J., Topalian, S.L., and Pardoll, D.M.: Published in final edited form as: J. Natl. Cancer Inst. 2011 Aug 17;103(16):1222-6. doi: 10.1093/jnci/djr246

Population pharmacokinetic analysis of sorafenib in patients with solid tumours
Lokesh Jain, Sukyung Woo, Erin R Gardner, William L Dahut, Elise C Kohn, Shivaani Kummar, Diane R Mould, Giuseppe Giaccone, Robert Yarchoan, Jürgen Venitz, William D Figg Br J Clin Pharmacol. 2011 August; 72(2): 294-305.doi: 10.1111/j.1365-2125.2011.03963.x

Target-Driven Pilot Trial of Oral Topotecan as an Inhibitor of Hypoxia Inducible Factor-1α (HIF-1α) in Advanced Solid Tumors
Kummar, S., Raffeld, M., Juwara, L., Horneffer, Y., Steinberg, S.M., Rapisarda, A., Figg, W.D., Turkbey, I.B., Choyke, P., Murgo, A.J., Doroshow, J.H., and Melillo, G.: Multihistology, Published in final edited form as: Clin. Cancer Res. 2011 Aug 1;17(15):5123-31 doi: 10.1158/1078-0432.

Phase I Trial of Vandetanib and Bevacizumab Evaluating the VEGF and EGF Signal Transduction Pathways in Adults with
Solid Tumors and Lymphomas

Kummar, S., Gutierrez, M., Chen, A., Turkbey, I.B., Allen, D., Horneffer, Y.R., Juwara, L., Cao, L., Yu, Y., Kim, Y.S., Trepel, J., Chen, H., Choyke, P., Melillo, G., Murgo, A.J., Collins, J., and Doroshow, J.H. Published in final edited form as : Eur. J. Cancer 2011 May;47(7):997-1005. doi: 10.1016/j.ejca.2010.12.016

Phase I Trial of Fenretinide Lym-X-Sorb Oral Powder in Adults with Solid Tumors and Lymphomas
Kummar, S., Gutierrez, M.E., Maurer, B.J., Reynolds, C.P., Kang, M., Singh, H., Crandon, S., Murgo, A.J., and Doroshow, J.H.: Published in final edited form as: Anticancer Res.2011 Mar;31(3):961-966

Phase 0 Trials: Expediting the Development of Chemoprevention Agents
Shivaani Kummar, James H. Doroshow Cancer Prev Res (Phila) Author manuscript; available in PMC 2012 March 1. Published in final edited form as: Cancer Prev Res (Phila). 2011 March; 4(3): 288-292.doi: 10.1158/1940-6207.CAPR-11-0013

A Phase I Trial of UCN-01 and Prednisone in Patients with Refractory Solid Tumors and Lymphomas
Kummar, S., Gutierrez, M.E., Gardner, E.R., Figg, W.D., Melillo, G., Dancey, J., Sausville, E.A., Conley, B.A., Murgo, A.J., and Doroshow, J.H. Published in final edited form as: Cancer Chemother. Pharmacol. 2010 Jan; 65(2):383-389.

Phase I Trial of 17-Dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), a Heat Shock Protein Inhibitor, Administered Twice Weekly in Patients with Advanced Malignancies
Kummar, S., Gutierrez, M.E., Gardner, E.R., Chen, X., Figg, W.D., Zajac-Kaye, M., Chen, M., Steinberg, S.M., Muir, C.A., Yancey, M.A., Horneffer, Y.R., Juwara, L., Melilo, G., Ivy, S.P., Merino, M., Neckers, L., Steeg, P.S., Conley, B.A., Giaccone, G., Doroshow, J.H., and Murgo, A.J Published in final edited form as : Eur. J. Cancer 2010 Jan; 46(2):340-347. doi: 10.1016./j.ejca.2009.10.026.

Phase 0 Clinical Trial of the Poly (ADP-Ribose) Polymerase Inhibitor ABT-888 in Patients With Advanced Malignancies
Shivaani Kummar, Robert Kinders, Martin E. Gutierrez, Larry Rubinstein, Ralph E. Parchment, Lawrence R. Phillips, Jiuping Ji, Anne Monks, Jennifer A. Low, Alice Chen, Anthony J. Murgo, Jerry Collins, Seth M. Steinberg, Helen Eliopoulos, Vincent L. Giranda, Gary Gordon, Lee Helman, Robert Wiltrout, Joseph E. Tomaszewski, James H. Doroshow J Clin Oncol. 2009 June 1; 27(16): 2705-2711. Published online 2009 April 24. doi: 10.1200/JCO.2008.19.7681

Phase 0 Clinical Trials: Recommendations from the Task Force on Methodology for the Development of Innovative Cancer Therapies
Shivaani Kummar, James H. Doroshow, Joseph E. Tomaszewski, A. Hilary Calvert, Marinus Lobbezoo, Giuseppe Giaccone, on behalf of the Task Force on Methodology for the Development of Innovative Cancer Therapies (MDICT)
Eur J Cancer. Author manuscript; available in PMC 2010 July 12. Published in final edited form as: Eur J Cancer. 2009 March; 45(5): 741-746. Published online 2008 December 16.doi: 10.1016/j.ejca.2008.10.024

Role of Insulin-like Growth Factor-1R System in Colorectal Carcinogenesis
Erin A Donovan, Shivaani Kummar Crit Rev Oncol Hematol. Author manuscript; available in PMC 2009 May 1.
Published in final edited form as: Crit Rev Oncol Hematol. 2008 May; 66(2): 91-98. Published online 2007 October 31.doi: 10.1016/j.critrevonc.2007.09.003