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Effects of a green tea extract, Polyphenon E, on systemic biomarkers of growth factor signalling in women with hormone receptor-negative breast cancer.

Crew KD,  Ho KA,  Brown P,  Greenlee H,  Bevers TB,  Arun B,  Sneige N,  Hudis C,  McArthur HL,  Chang J,  Rimawi M,  Cornelison TL,  Cardelli J,  Santella RM,  Wang A,  Lippman SM,  Hershman DL
J Hum Nutr Diet 2015 Jun;28(3):272-82
PubMed ID: 24646362
PMC ID: PMC4205214
Groups or Programs: Phase 0/I/II Trials

Long-term effects of inhaled budesonide on screening-detected lung nodules.

Veronesi G,  Lazzeroni M,  Szabo E,  Brown PH,  DeCensi A,  Guerrieri-Gonzaga A,  Bellomi M,  Radice D,  Grimaldi MC,  Spaggiari L,  Bonanni B
Ann Oncol 2015 May;26(5):1025-30
PubMed ID: 25672894
PMC ID: PMC4405280
Groups or Programs: Phase 0/I/II Trials

Soy food frequency questionnaire does not correlate with baseline isoflavone levels in patients with bladder cancer.

Kolesar JM,  Pomplun M,  Havighurst T,  Stublaski J,  Wollmer B,  Kim K,  Tangrea JA,  Parnes HL,  House MG,  Gee J,  Messing E,  Bailey HH
J Oncol Pharm Pract 2015 Apr;21(2):128-31
PubMed ID: 24642450
PMC ID: PMC4261043
Groups or Programs: Prostate and Urologic CancerPhase 0/I/II Trials

A pilot clinical study of resveratrol in postmenopausal women with high body mass index: effects on systemic sex steroid hormones.

Chow HH,  Garland LL,  Heckman-Stoddard BM,  Hsu CH,  Butler VD,  Cordova CA,  Chew WM,  Cornelison TL
J Transl Med 2014 Aug 14;12:223
PubMed ID: 25115686
PMC ID: PMC4243716
Groups or Programs: Phase 0/I/II Trials

A randomized phase II presurgical trial of transdermal 4-hydroxytamoxifen gel versus oral tamoxifen in women with ductal carcinoma in situ of the breast.

Lee O,  Page K,  Ivancic D,  Helenowski I,  Parini V,  Sullivan ME,  Margenthaler JA,  Chatterton RT Jr,  Jovanovic B,  Dunn BK,  Heckman-Stoddard BM,  Foster K,  Muzzio M,  Shklovskaya J,  Skripkauskas S,  Kulesza P,  Green D,  Hansen NM,  Bethke KP,  Jeruss JS,  Bergan R,  Khan SA
Clin Cancer Res 2014 Jul 15;20(14):3672-82
PubMed ID: 25028506
PMC ID: PMC4101910
Groups or Programs: Chemopreventive Agent DevelopmentPhase 0/I/II Trials

A multicenter phase II study of docosahexaenoic acid (DHA) in patients (pts) with a history of breast cancer (BC), premalignant lesions, or benign breast disease.

Gucalp A,  Morris PG,  Zhou XK,  Giri DD,  Iyengar NM,  Crew KD,  Hershman DL,  Garber JE,  Nangia JR,  Cook ED,  Vornik LA,  Heckman-Stoddard BM,  Dunn BK,  Foster K,  Brown PH,  Dannenberg AJ,  Hudis CA
J Clin Oncol 2014 May 20;32(15, Suppl S):Abstract TPS1615
PubMed ID: not available
PMC ID: not available
Groups or Programs: Phase 0/I/II Trials

A randomized, double-blind, placebo-controlled phase II clinical trial of lovastatin for various endpoints of melanoma pathobiology.

Linden KG,  Leachman SA,  Zager JS,  Jakowatz JG,  Viner JL,  McLaren CE,  Barr RJ,  Carpenter PM,  Chen WP,  Elmets CA,  Tangrea JA,  Lim SJ,  Cochran AJ,  Meyskens FL Jr
Cancer Prev Res (Phila) 2014 May;7(5):496-504
PubMed ID: 24614012
PMC ID: PMC4208700
Groups or Programs: Phase 0/I/II Trials

Assessment of Interest for Breast Cancer Prevention Trial Participation among BRCA Mutation Carriers.

Hurley RM,  Suman V,  Daly M,  Mandrekar S,  Limburg PJ,  Pruthi S
Hereditary Genet 2014 Apr 26;3(2):127
PubMed ID: not available
PMC ID: not available
Groups or Programs: Phase 0/I/II Trials

Results of a phase II randomized, double-blind, placebo-controlled trial of Polyphenon E in women with persistent high-risk HPV infection and low-grade cervical intraepithelial neoplasia.

Garcia FA,  Cornelison T,  Nuño T,  Greenspan DL,  Byron JW,  Hsu CH,  Alberts DS,  Chow HH
Gynecol Oncol 2014 Feb;132(2):377-82
PubMed ID: 24388920
PMC ID: PMC3955221
Groups or Programs: Breast and Gynecologic CancerPhase 0/I/II Trials

Abstract OT3-3-01: A multicenter phase II study of docosahexaenoic acid (DHA) in triple negative breast cancer (TNBC) survivors.

Gucalp A,  Morris PG,  Zhou XK,  Giri DD,  Iyengar NM,  Heckman-Stoddard BM,  Dunn B,  Garber JE,  Crew KD,  Hershman DL,  Nangia JR,  Cook ED,  Brown PH,  Dannenberg AJ,  Hudis CA
Cancer Res 2013 Dec 15;73(24 Suppl):OT3-01
PubMed ID: not available
PMC ID: not available
Groups or Programs: Phase 0/I/II Trials

Abstract C48: Phase Ib randomized, double-blinded, placebo-controlled, dose escalation study of Polyphenon E in patients with Barrett's esophagus.

Joe AK,  Schnoll-Sussman F,  Bresalier RS,  Abrams JA,  Hibshoosh HH,  Cheung K,  Friedman RA,  Yang CS,  Milne G,  Liu DD,  Lee S,  Abdul K,  Bigg M,  Foreman J,  Su T,  Ahmed A,  Neugut AI,  Akpa E,  Lippman SM,  Perloff M,  Brown PH,  Lightdale CJ
Cancer Prev Res 2013 Nov;6(11 Suppl):C48
PubMed ID: not available
PMC ID: not available
Groups or Programs: Phase 0/I/II Trials

A phase I trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia.

Wong SJ,  Campbell B,  Massey B,  Lynch DP,  Cohen EEW,  Blair E,  Selle R,  Shklovskaya J,  Jovanovic BD,  Skripkauskas S,  Dew A,  Kulesza P,  Parimi V,  Bergan RC,  Szabo E
Oral Oncol 2013 Sep;49(9):970-976
PubMed ID: 23845699
PMC ID: PMC4456032
Groups or Programs: Phase 0/I/II TrialsLung and Upper Aerodigestive Cancer

Prospective multicenter randomized intermediate biomarker study of oral contraceptive versus depo-provera for prevention of endometrial cancer in women with Lynch syndrome.

Lu KH,  Loose DS,  Yates MS,  Nogueras-Gonzalez GM,  Munsell MF,  Chen LM,  Lynch H,  Cornelison T,  Boyd-Rogers S,  Rubin M,  Daniels MS,  Conrad P,  Milbourne A,  Gershenson DM,  Broaddus RR
Cancer Prev Res (Phila) 2013 Aug;6(8):774-81
PubMed ID: 23639481
PMC ID: PMC3737517
Groups or Programs: Phase 0/I/II TrialsBreast and Gynecologic Cancer

Effect of zileuton and celecoxib on urinary LTE4 and PGE-M levels in smokers.

Mohebati A,  Milne GL,  Zhou XK,  Duffield-Lillico AJ,  Boyle JO,  Knutson A,  Bosworth BP,  Kingsley PJ,  Marnett LJ,  Brown PH,  Akpa EG,  Szabo E,  Dannenberg AJ
Cancer Prev Res (Phila) 2013 Jul;6(7):646-55
PubMed ID: 23682075
PMC ID: PMC3707304
Groups or Programs: Phase 0/I/II TrialsLung and Upper Aerodigestive Cancer

Abstract LB-195: A double-blind randomized controlled multisite trial evaluating tissue effects of preoperative finasteride in clinically organ-confined prostate cancer: Pathologic outcomes.

Kim J,  Davis JW,  Klein EA,  Magi-Galluzzi C,  Lotan Y,  Ward JF,  Pisters LL,  Basler JW,  Pettaway CA,  Li Ning Tapia EM,  Wang X,  Do KA,  Lee J,  Vornik LA,  Tangrea J,  Parnes HL,  Lippman SM,  Thompson IM,  Brown PH,  Troncoso P,  Logothetis CJ
Cancer Res 2013 Apr 15;73(8 Suppl):LB-195
PubMed ID: not available
PMC ID: not available
Groups or Programs: Phase 0/I/II Trials

Population pharmacokinetic model for cancer chemoprevention with sulindac in healthy subjects.

Berg AK,  Mandrekar SJ,  Ziegler KL,  Carlson EC,  Szabo E,  Ames MM,  Boring D,  Limburg PJ,  Reid JM,  Cancer Prevention Network
J Clin Pharmacol 2013 Apr;53(4):403-12
PubMed ID: 23436338
PMC ID: PMC4120995
Groups or Programs: Phase 0/I/II TrialsLung and Upper Aerodigestive CancerChemopreventive Agent Development

Recruitment strategy cost and impact on minority accrual to a breast cancer prevention trial.

Dew A,  Khan S,  Babinski C,  Michel N,  Heffernan M,  Stephan S,  Jordan N,  Jovanovic B,  Carney P,  Bergan R
Clin Trials 2013 Apr;10(2):292-9
PubMed ID: 23321266
PMC ID: not available
Groups or Programs: Phase 0/I/II Trials

Randomized phase II trial of sulindac for lung cancer chemoprevention.

Limburg PJ,  Mandrekar SJ,  Aubry MC,  Ziegler KL,  Zhang J,  Yi JE,  Henry M,  Tazelaar HD,  Lam S,  McWilliams A,  Midthun DE,  Edell ES,  Rickman OB,  Mazzone P,  Tockman M,  Beamis JF,  Lamb C,  Simoff M,  Loprinzi C,  Szabo E,  Jett J,  Cancer Prevention Network
Lung Cancer 2013 Mar;79(3):254-61
PubMed ID: 23261228
PMC ID: PMC3566344
Groups or Programs: Phase 0/I/II TrialsLung and Upper Aerodigestive Cancer

Randomized, double-blind, placebo-controlled trial of sulindac in individuals at risk for melanoma: evaluation of potential chemopreventive activity.

Curiel-Lewandrowski C,  Swetter SM,  Einspahr JG,  Hsu CH,  Nagle R,  Sagerman P,  Tangrea J,  Parnes H,  Alberts DS,  Chow HH
Cancer 2012 Dec 1;118(23):5848-56
PubMed ID: 22605570
PMC ID: PMC3517927
Groups or Programs: Prostate and Urologic CancerPhase 0/I/II Trials

Abstract B17: Phase I prevention study of atorvastatin in women at increased risk for breast cancer.

Arun B,  Gong Y,  Liu D,  Litton J,  Gutierrez-Barrera A,  Sajan B,  Lee JJ,  Vornik LA,  Cornelison T,  Hortobagyi GN,  Lippman S,  Brown PH,  Sneige N
Cancer Prev Res 2012 Nov;5(11 Suppl):B17
PubMed ID: not available
PMC ID: not available
Groups or Programs: Phase 0/I/II Trials

Abstract B65: Biomarker effects of an oral green tea extract, Polyphenon E, in women with a history of hormone receptor-negative breast cancer.

Crew KD,  Ho KA,  Brown P,  Greenlee H,  Bevers TB,  Arun B,  Hudis C,  McArthur HL,  Chang J,  Rimawi M,  Vornik L,  Cornelison TL,  Cardelli J,  Santella RM,  Wang A,  Lippman SM,  Hershman DL
Cancer Prev Res 2012 Nov;5(11 Suppl):B65
PubMed ID: not available
PMC ID: not available
Groups or Programs: Phase 0/I/II Trials

A combination of esomeprazole and aspirin reduces tissue concentrations of prostaglandin E(2) in patients with Barrett's esophagus.

Falk GW,  Buttar NS,  Foster NR,  Ziegler KL,  Demars CJ,  Romero Y,  Marcon NE,  Schnell T,  Corley DA,  Sharma P,  Cruz-Correa MR,  Hur C,  Fleischer DE,  Chak A,  Devault KR,  Weinberg DS,  Della'Zanna G,  Richmond E,  Smyrk TC,  Mandrekar SJ,  Limburg PJ,  Cancer Prevention Network
Gastroenterology 2012 Oct;143(4):917-26.e1
PubMed ID: 22796132
PMC ID: PMC3458136
Groups or Programs: Gastrointestinal and Other CancersPhase 0/I/II Trials

Phase IB randomized, double-blinded, placebo-controlled, dose escalation study of polyphenon E in women with hormone receptor-negative breast cancer.

Crew KD,  Brown P,  Greenlee H,  Bevers TB,  Arun B,  Hudis C,  McArthur HL,  Chang J,  Rimawi M,  Vornik L,  Cornelison TL,  Wang A,  Hibshoosh H,  Ahmed A,  Terry MB,  Santella RM,  Lippman SM,  Hershman DL
Cancer Prev Res (Phila) 2012 Sep;5(9):1144-54
PubMed ID: 22827973
PMC ID: PMC3816771
Groups or Programs: Phase 0/I/II TrialsBreast and Gynecologic Cancer

A web-based screening and accrual strategy for a cancer prevention clinical trial in healthy smokers.

Mohebati A,  Knutson A,  Zhou XK,  Smith JJ,  Brown PH,  Dannenberg AJ,  Szabo E
Contemp Clin Trials 2012 Sep;33(5):942-8
PubMed ID: 22771576
PMC ID: PMC3460548
Groups or Programs: Phase 0/I/II TrialsLung and Upper Aerodigestive Cancer

A phase 2 cancer chemoprevention biomarker trial of isoflavone G-2535 (genistein) in presurgical bladder cancer patients.

Messing E,  Gee JR,  Saltzstein DR,  Kim K,  diSant'Agnese A,  Kolesar J,  Harris L,  Faerber A,  Havighurst T,  Young JM,  Efros M,  Getzenberg RH,  Wheeler MA,  Tangrea J,  Parnes H,  House M,  Busby JE,  Hohl R,  Bailey H
Cancer Prev Res (Phila) 2012 Apr;5(4):621-30
PubMed ID: 22293631
PMC ID: PMC3324663
Groups or Programs: Prostate and Urologic CancerPhase 0/I/II Trials

Soy isoflavone supplementation for breast cancer risk reduction: a randomized phase II trial.

Khan SA,  Chatterton RT,  Michel N,  Bryk M,  Lee O,  Ivancic D,  Heinz R,  Zalles CM,  Helenowski IB,  Jovanovic BD,  Franke AA,  Bosland MC,  Wang J,  Hansen NM,  Bethke KP,  Dew A,  Coomes M,  Bergan RC
Cancer Prev Res (Phila) 2012 Feb;5(2):309-19
PubMed ID: 22307566
PMC ID: PMC3333836
Groups or Programs: Phase 0/I/II Trials

Randomized, double-blind, placebo-controlled trial of polyphenon E in prostate cancer patients before prostatectomy: evaluation of potential chemopreventive activities.

Nguyen MM,  Ahmann FR,  Nagle RB,  Hsu CH,  Tangrea JA,  Parnes HL,  Sokoloff MH,  Gretzer MB,  Chow HH
Cancer Prev Res (Phila) 2012 Feb;5(2):290-8
PubMed ID: 22044694
PMC ID: PMC3273617
Groups or Programs: Prostate and Urologic CancerPhase 0/I/II Trials

Methyl selenocysteine: single-dose pharmacokinetics in men.

Marshall JR,  Ip C,  Romano K,  Fetterly G,  Fakih M,  Jovanovic B,  Perloff M,  Crowell J,  Davis W,  French-Christy R,  Dew A,  Coomes M,  Bergan R
Cancer Prev Res (Phila) 2011 Nov;4(11):1938-44
PubMed ID: 21846796
PMC ID: PMC3208773
Groups or Programs: Phase 0/I/II TrialsChemopreventive Agent Development

Abstract A52: A phase III skin cancer chemoprevention study of DFMO in subjects with a history of non-melanoma skin cancer (NMSC): Follow-up of NMSC events greater than 5 years post-study participation.

Lamont SM,  Kim K,  Havighurst T,  Mendonca EA,  Wood GS,  Snow S,  Bailey HH
Conference Proceeding
2011 October
Groups or Programs: Phase 0/I/II Trials

Phase IIA trial testing erlotinib as an intervention against intraductal pancreatic mucinous neoplasms.

Lipkin S,  Lee J,  Imagawa D,  Hewitt SM,  Tucker C,  Zell JA,  Wong V,  Garcia A,  Gonzalez R,  Della Zanna G,  Richmond E,  Rodriguez LM,  Bigg M,  Schnoll-Sussmans F,  Meyskens F
Cancer Prev Res (Phila) 2011 Apr;4(4):512-3
PubMed ID: 21464031
PMC ID: PMC4492452
Groups or Programs: Gastrointestinal and Other CancersPhase 0/I/II Trials

Phase IIa clinical trial of curcumin for the prevention of colorectal neoplasia.

Carroll RE,  Benya RV,  Turgeon DK,  Vareed S,  Neuman M,  Rodriguez L,  Kakarala M,  Carpenter PM,  McLaren C,  Meyskens FL Jr,  Brenner DE
Cancer Prev Res (Phila) 2011 Mar;4(3):354-64
PubMed ID: 21372035
PMC ID: PMC4136551
Groups or Programs: Gastrointestinal and Other CancersPhase 0/I/II Trials

Phase 0 clinical chemoprevention trial of the Akt inhibitor SR13668.

Reid JM,  Walden CA,  Qin R,  Ziegler KL,  Haslam JL,  Rajewski RA,  Warndahl R,  Fitting CL,  Boring D,  Szabo E,  Crowell J,  Perloff M,  Jong L,  Bauer BA,  Mandrekar SJ,  Ames MM,  Limburg PJ,  Cancer Prevention Network
Cancer Prev Res (Phila) 2011 Mar;4(3):347-53
PubMed ID: 21372034
PMC ID: PMC3061470
Groups or Programs: Lung and Upper Aerodigestive CancerChemopreventive Agent DevelopmentPhase 0/I/II Trials

Randomized phase II trial of sulindac, atorvastatin, and prebiotic dietary fiber for colorectal cancer chemoprevention.

Limburg PJ,  Mahoney MR,  Ziegler KL,  Sontag SJ,  Schoen RE,  Benya R,  Lawson MJ,  Weinberg DS,  Stoffel E,  Chiorean M,  Heigh R,  Levine J,  Della'Zanna G,  Rodriguez L,  Richmond E,  Gostout C,  Mandrekar SJ,  Smyrk TC,  Cancer Prevention Network
Cancer Prev Res (Phila) 2011 Feb;4(2):259-69
PubMed ID: 21209397
PMC ID: PMC3046804
Groups or Programs: Gastrointestinal and Other CancersPhase 0/I/II Trials

Randomized phase II trial of inhaled budesonide versus placebo in high-risk individuals with CT screen-detected lung nodules.

Veronesi G,  Szabo E,  Decensi A,  Guerrieri-Gonzaga A,  Bellomi M,  Radice D,  Ferretti S,  Pelosi G,  Lazzeroni M,  Serrano D,  Lippman SM,  Spaggiari L,  Nardi-Pantoli A,  Harari S,  Varricchio C,  Bonanni B
Cancer Prev Res (Phila) 2011 Jan;4(1):34-42
PubMed ID: 21163939
PMC ID: PMC3017323
Groups or Programs: Lung and Upper Aerodigestive CancerPhase 0/I/II Trials

Abstract PR-10: Randomized placebo controlled trial of pioglitazone for oral premalignant lesions: A cross-consortium collaborative study in progress.

Boyle JO,  Ondrey FG,  Brown PH,  Bailey HH,  Kim KM,  El-Naggar AK,  Szabo EM
Cancer Prev Res 2010 Dec;3(12 Suppl):PR-10
PubMed ID: not available
PMC ID: not available
Groups or Programs: Phase 0/I/II Trials

A pilot, first-in-human, pharmacokinetic study of 9cUAB30 in healthy volunteers.

Kolesar JM,  Hoel R,  Pomplun M,  Havighurst T,  Stublaski J,  Wollmer B,  Krontiras H,  Brouillette W,  Muccio D,  Kim K,  Grubbs CJ,  Bailey HE
Cancer Prev Res (Phila) 2010 Dec;3(12):1565-70
PubMed ID: 21149332
PMC ID: PMC3204611
Groups or Programs: Phase 0/I/II Trials

Budesonide versus placebo in high-risk population with screen-detected lung nodules: rationale, design and methodology.

Lazzeroni M,  Guerrieri-Gonzaga A,  Serrano D,  Varricchio MC,  Veronesi G,  Radice D,  Feroce I,  Nardi-Pantoli A,  Lippman SM,  Szabo E,  Bonanni B
Contemp Clin Trials 2010 Nov;31(6):612-9
PubMed ID: 20719253
PMC ID: PMC2962433
Groups or Programs: Lung and Upper Aerodigestive CancerPhase 0/I/II Trials

Resveratrol modulates drug- and carcinogen-metabolizing enzymes in a healthy volunteer study.

Chow HH,  Garland LL,  Hsu CH,  Vining DR,  Chew WM,  Miller JA,  Perloff M,  Crowell JA,  Alberts DS
Cancer Prev Res (Phila) 2010 Sep;3(9):1168-75
PubMed ID: 20716633
PMC ID: PMC2933312
Groups or Programs: Phase 0/I/II TrialsChemopreventive Agent Development

Green tea compound in chemoprevention of cervical cancer.

Zou C,  Liu H,  Feugang JM,  Hao Z,  Chow HH,  Garcia F
Int J Gynecol Cancer 2010 May;20(4):617-24
PubMed ID: 20686382
PMC ID: PMC2918290
Groups or Programs: Breast and Gynecologic CancerPhase 0/I/II Trials

Sulindac and sulindac metabolites in nipple aspirate fluid and effect on drug targets in a phase I trial.

Thompson PA,  Hsu CH,  Green S,  Stopeck AT,  Johnson K,  Alberts DS,  Chow HH
Cancer Prev Res (Phila) 2010 Jan;3(1):101-7
PubMed ID: 20051377
PMC ID: PMC3993089
Groups or Programs: Phase 0/I/II Trials

Randomized phase II trial of budesonide versus placebo in high-risk population with screening-detected lung nodules: Update on secondary endpoints.

Bonanni B,  Guerrieri-Gonzaga A,  Radice D,  Serrano D,  Varricchio C,  Ferretti S,  Johansson H,  Szabo E,  Decensi A,  Veronesi G
J Clin Oncol 2009;27(17S):1518
PubMed ID: not available
PMC ID: not available
Groups or Programs: Phase 0/I/II Trials

Comparative bioavailability of sulindac in capsule and tablet formulations.

Reid JM,  Mandrekar SJ,  Carlson EC,  Harmsen WS,  Green EM,  McGovern RM,  Szabo E,  Ames MM,  Boring D,  Limburg PJ,  Cancer Prevention Network
Cancer Epidemiol Biomarkers Prev 2008 Mar;17(3):674-9
PubMed ID: 18349286
PMC ID: PMC2435402
Groups or Programs: Lung and Upper Aerodigestive CancerPhase 0/I/II TrialsChemopreventive Agent Development