Phase Ib study of PEGylated recombinant human hyaluronidase and gemcitabine in patients with advanced pancreatic cancer

Clinical Cancer Research

Volumn 22, Issue 12, 2016, Pages 2848-2854

  Hingorani, Sunil R ^a,b   Harris, William P ^a,b   Beck, J Thaddeus ^c   Berdov, Boris A ^d   Wagner, Stephanie A ^e   Pshevlotsky, Eduard M ^f   Tjulandin, Sergei A ^g   Gladkov, Oleg A ^h   Holcombe, Randall F ⁱ   Korn, Ronald ^j   Raghunand, Natarajan ^k   Dychter, Samuel ^l   Jiang, Ping ^l   Shepard, H Michael ^l   Devoe, Craig E ^m  

^a Fred Hutchinson Cancer Research Center   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c Highlands Oncology Group   (United States)

^d MEDICAL RADIOLOGICAL RESEARCH CENTER   (Russian Federation)

^e INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f OMSK STATE MEDICAL UNIVERSITY   (Russian Federation)

^g N N BLOKHIN RUSSIAN CANCER RESEARCH CENTER   (Russian Federation)

^h Chelyabinsk Regional Clinical Oncology Center   (Russian Federation)

ⁱ MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^j Imaging Endpoints Core Lab   (United States)

^k H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^l Halozyme Therapeutics   (United States)

^m DONALD AND BARBARA ZUCKER SCHOOL OF MEDICINE AT HOFSTRA NORTHWELL   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CA 19-9 ANTIGEN; DEXAMETHASONE; GEMCITABINE; HYALURONIC ACID; RECOMBINANT HYALURONIDASE; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; HYALURONOGLUCOSAMINIDASE; MACROGOL DERIVATIVE; RECOMBINANT PROTEIN;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTHRALGIA; ARTICLE; ASTHENIA; BASAL GANGLIA INFARCTION; CANCER STAGING; CANCER SURVIVAL; CEREBROVASCULAR ACCIDENT; CLINICAL ARTICLE; CONTROLLED STUDY; DECREASED APPETITE; DEEP VEIN THROMBOSIS; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; EXTRAPYRAMIDAL SYNDROME; FATIGUE; FEMALE; GOOD CLINICAL PRACTICE; HUMAN; INSOMNIA; JUGULAR VEIN THROMBOSIS; KARNOFSKY PERFORMANCE STATUS; LIMB PAIN; LUNG EMBOLISM; MALE; MUSCLE SPASM; MUSCULOSKELETAL PAIN; MYALGIA; NAUSEA; OVERALL SURVIVAL; PANCREAS ADENOCARCINOMA; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SPLEEN INFARCTION; SURVIVAL RATE; THROMBOCYTOPENIA; THROMBOEMBOLISM; UPPER ABDOMINAL PAIN; VEIN THROMBOSIS; VOMITING; ANALOGS AND DERIVATIVES; CHEMISTRY; CLINICAL TRIAL; DISEASE FREE SURVIVAL; GENETICS; LIVER TUMOR; LUNG TUMOR; LYMPH NODE METASTASIS; MIDDLE AGED; MULTICENTER STUDY; PANCREAS; PANCREAS CARCINOMA; PANCREAS TUMOR; PATHOLOGY; RUSSIAN FEDERATION; SECONDARY; TREATMENT OUTCOME; UNITED STATES; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, PANCREATIC DUCTAL; DEOXYCYTIDINE; DEXAMETHASONE; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; HYALURONOGLUCOSAMINIDASE; LIVER NEOPLASMS; LUNG NEOPLASMS; LYMPHATIC METASTASIS; MALE; MIDDLE AGED; PANCREAS; PANCREATIC NEOPLASMS; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS; RUSSIA; TREATMENT OUTCOME; UNITED STATES;

EID: 84975091164     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-15-2010     Document Type: Article

References (24)

1. Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res 2014;74:2913-21.
2. Burris HA3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 1997;15:2403-13.
3. Arshad A, Al-Leswas D, Al-Taan O, Stephenson J, Metcalfe M, Steward WP, et al. Pooled survival and response data from phase III randomized controlled trials for gemcitabine-based regimes in the treatment of advanced pancreatic cancer. Am J Clin Oncol 2013;36:411-4.
4. Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med 2013;369:1691-703.
5. Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011;364:1817-25.
6. Hertel LW, Boder GB, Kroin JS, Rinzel SM, Poore GA, Todd GC, et al. Evaluation of the antitumor activity of gemcitabine (2′,2′-difluoro-2′-deoxycytidine). Cancer Res 1990;50:4417-22.
7. Singh M, Ferrara N. Modeling and predicting clinical efficacy for drugs targeting the tumor milieu. Nat Biotechnol 2012;30:648-57.
8. Jacobetz MA, Chan DS, Neesse A, Bapiro TE, Cook N, Frese KK, et al. Hyaluronan impairs vascular function and drug delivery in a mouse model of pancreatic cancer. Gut 2013;62:112-20.
9. Whatcott CJ, Diep CH, Jiang P, Watanabe A, LoBello J, Sima C, et al. Desmoplasia in primary tumors and metastatic lesions of pancreatic cancer. Clin Cancer Res 2015;21:3561-8.
10. Thompson CB, Shepard HM, O'Connor PM, Kadhim S, Jiang P, Osgood RJ, et al. Enzymatic depletion of tumor hyaluronan induces antitumor responses in preclinical animal models. Mol Cancer Ther 2010;9:3052-64.
11. Provenzano PP, Cuevas C, Chang AE, Goel VK, Von Hoff DD, Hingorani SR. Enzymatic targeting of the stroma ablates physical barriers to treatment of pancreatic ductal adenocarcinoma. Cancer Cell 2012;21:418-29.
12. McLeskey SB, Dowds C, Carballada R, White RR, Saling PM. Molecules involved in mammalian sperm-egg interaction. Int Rev Cytol 1998;177:57-113.
13. Jiang P, Li X, Thompson CB, Huang Z, Araiza F, Osgood R, et al. Effective targeting of the tumor microenvironment for cancer therapy. Anticancer Res 2012;32:1203-12.
14. Baumgartner G, Gomar-Hoss C, Sakr L, Ulsperger E, Wogritsch C. The impact of extracellular matrix on the chemoresistance of solid tumors - experimental and clinical results of hyaluronidase as additive to cytostatic chemotherapy. Cancer Lett 1998;131:85-99.
15. Jiang P, Maneval DC, Ramanathan RK, Infante JR, Borad M, Bessudo A, et al. Abstract 3375: Phase 1 pharmacodyamic activity of multiple-dose PEGylated hyaluronidase PH20 (PEGPH20) in patients with solid tumors. Cancer Res 2013;73:3375.
16. Borad M, Ramanathan RK, Bessudo A, LoRusso P, Shepard H, Maneval D, et al. Targeting hyaluronan (HA) in tumor stroma: A phase I study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of pegylated hyaluronidase (PEGPH20) in patients with solid tumors. J Clin Oncol 2012;30:Suppl, Abstract 2579.
17. Rajaraman S, Rodriguez JJ, Graff C, Altbach MI, Dragovich T, Sirlin CB, et al. Automated registration of sequential breath-hold dynamic contrast-enhanced MR images: a comparison of three techniques. Magn Reson Imaging 2011;29:668-82.
18. Auvinen P, Tammi R, Parkkinen J, Tammi M, Agren U, Johansson R, et al. Hyaluronan in peritumoral stroma and malignant cells associates with breast cancer spreading and predicts survival. Am J Pathol 2000;156:529-36.
19. Pelzer U, Opitz B, Deutschinoff G, Stauch M, Reitzig PC, Hahnfeld S, et al. Efficacy of prophylactic low-molecular weight heparin for ambulatory patients with advanced pancreatic cancer: outcomes from the CONKO-004 trial. J Clin Oncol 2015;33:2028-34.
20. Maraveyas A, Waters J, Roy R, Fyfe D, Propper D, Lofts F, et al. Gemcitabine versus gemcitabine plus dalteparin thromboprophylaxis in pancreatic cancer. Eur J Cancer 2012;48:1283-92.
21. Chan K, Shah K, Lien K, Coyle D, Lam H, Ko YJ. A Bayesian meta-analysis of multiple treatment comparisons of systemic regimens for advanced pancreatic cancer. PLoS One 2014;9:e108749.
22. Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2007;25:1960-6.
23. Khorana AA, Fine RL. Pancreatic cancer and thromboembolic disease. Lancet Oncol 2004;5:655-63.
24. Lyman GH, Eckert L, Wang Y, Wang H, Cohen A. Venous thromboembolism risk in patients with cancer receiving chemotherapy: a real-world analysis. Oncologist 2013;18:1321-9.