Principal Investigator

Jay W
Carlson
Awardee Organization

Ozark Health Ventures, Llc
United States

Fiscal Year
2023
Activity Code
UG1
Early Stage Investigator Grants (ESI)
Not Applicable
Project End Date

Ozark Health Ventures LLC dba Cancer Research for the Ozarks (CRO)

1 Ozark Health Ventures, LLC d/b/a Cancer Research for the Ozarks (CRO) is submitting 2 this grant application as it desires to continue to be involved with the cooperative efforts 3 of the NCI Community Oncology Research Program (NCORP) to focus on the broader 4 needs of cancer prevention and treatment, cancer care delivery, imaging studies and 5 cancer disparities. 6 Cancer Research for the Ozarks has a long and mutually beneficial history with the NCI 7 for over 31 years of offering clinical trial access to rural communities within the central 8 United States. Since its inception, CRO has grown from southwest Missouri, to 9 increasing its network to 15 component sites that incorporate 42 counties in five states 10 with a predominately rural population of more than 4,300,000. CRO would be the 11 primary access for NCI-sponsored and NTCN network trials for the vast majority of these 12 patients. The population in CRO’s catchment area is generally Caucasian, and slightly 13 older and poorer than national averages. CRO has been a significant contributor to 14 enrollments in protocols involving cancer prevention and treatment, cancer care delivery, 15 imaging studies, and cancer disparities. CRO has also had numerous registrations to 16 cancer care delivery and tissue procurement protocols. CRO routinely meets the NCI 17 criteria for enrollments and for the number of CCDR protocols it has open. CRO has a 18 plan for further expansion of components and investigators to secure even higher 19 enrollments. CRO participates with the following research bases: Alliance: member since 20 June, 2012; NRG: member since their merger in 2014 and the preceding legacy groups; 21 SWOG: member since its inception in 1987; Wake Forest: member since their inception 22 in 2014 and participated in protocols with the preceding Cancer Center; ECOG-ACRIN: 23 member since 2014 and the preceding legacy groups. In addition, CRO has been 24 involved in the Children’s Oncology Group at Mercy St. Louis since June 2011. The 25 major collective strengths of the CRO application would be the tremendous support and 26 commitment of the two primary components, the broad network of component sites, the 27 quality, integrity and experience of CRO’s leadership and the program, and the many 28 investigators and collaborators that it supports. 29

Publications

  • Henry NL, Unger JM, Schott AF, Fehrenbacher L, Flynn PJ, Prow DM, Sharer CW, Burton GV, Kuzma CS, Moseley A, Lew DL, Fisch MJ, Moinpour CM, Hershman DL, Wade JL 3rd. Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2018 Feb 1;36(4):326-332. Epub 2017 Nov 14. PMID: 29136387
  • Kopetz S, Guthrie KA, Morris VK, Lenz HJ, Magliocco AM, Maru D, Yan Y, Lanman R, Manyam G, Hong DS, Sorokin A, Atreya CE, Diaz LA, Allegra C, Raghav KP, Wang SE, Lieu CH, McDonough SL, Philip PA, Hochster HS. Randomized Trial of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF-Mutant Metastatic Colorectal Cancer (SWOG S1406). Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021 Feb 1;39(4):285-294. Epub 2020 Dec 23. PMID: 33356422
  • Puvvada SD, Stiff PJ, Leblanc M, Cook JR, Couban S, Leonard JP, Kahl B, Marcellus D, Shea TC, Winter JN, Li H, Rimsza LM, Friedberg JW, Smith SM. Outcomes of MYC-associated lymphomas after R-CHOP with and without consolidative autologous stem cell transplant: subset analysis of randomized trial intergroup SWOG S9704. British journal of haematology. 2016 Sep;174(5):686-91. Epub 2016 Apr 13. PMID: 27072903
  • Carlson JW, Kauderer J, Hutson A, Carter J, Armer J, Lockwood S, Nolte S, Stewart BR, Wenzel L, Walker J, Fleury A, Bonebrake A, Soper J, Mathews C, Zivanovic O, Richards WE, Tan A, Alberts DS, Barakat RR. GOG 244-The lymphedema and gynecologic cancer (LEG) study: Incidence and risk factors in newly diagnosed patients. Gynecologic oncology. 2020 Feb;156(2):467-474. Epub 2019 Dec 16. PMID: 31837831
  • Ahmad SA, Duong M, Sohal DPS, Gandhi NS, Beg MS, Wang-Gillam A, Wade JL 3rd, Chiorean EG, Guthrie KA, Lowy AM, Philip PA, Hochster HS. Surgical Outcome Results From SWOG S1505: A Randomized Clinical Trial of mFOLFIRINOX Versus Gemcitabine/Nab-paclitaxel for Perioperative Treatment of Resectable Pancreatic Ductal Adenocarcinoma. Annals of surgery. 2020 Sep 1;272(3):481-486. PMID: 32740235
  • Hussain M, Tangen CM, Thompson IM Jr, Swanson GP, Wood DP, Sakr W, Dawson NA, Haas NB, Flaig TW, Dorff TB, Lin DW, Crawford ED, Quinn DI, Vogelzang NJ, Glode LM. Phase III Intergroup Trial of Adjuvant Androgen Deprivation With or Without Mitoxantrone Plus Prednisone in Patients With High-Risk Prostate Cancer After Radical Prostatectomy: SWOG S9921. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2018 May 20;36(15):1498-1504. Epub 2018 Apr 6. PMID: 29624463
  • Provencher DM, Gallagher CJ, Parulekar WR, Ledermann JA, Armstrong DK, Brundage M, Gourley C, Romero I, Gonzalez-Martin A, Feeney M, Bessette P, Hall M, Weberpals JI, Hall G, Lau SK, Gauthier P, Fung-Kee-Fung M, Eisenhauer EA, Winch C, Tu D, MacKay HJ. OV21/PETROC: a randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer. Annals of oncology : official journal of the European Society for Medical Oncology. 2018 Feb 1;29(2):431-438. PMID: 29186319
  • Iqbal S, McDonough S, Lenz HJ, Ilson D, Burtness B, Nangia CS, Barzi A, Schneider CJ, Liu JJ, Dotan E, Guthrie KA, Hochster HS. Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of ERCC1: SWOG S1201. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2020 Feb 10;38(5):472-479. Epub 2019 Dec 9. PMID: 31815582
  • West HL, Moon J, Wozniak AJ, Mack P, Hirsch FR, Bury MJ, Kwong M, Nguyen DD, Moore DF, Miao J, Redman M, Kelly K, Gandara DR. Paired Phase II Studies of Erlotinib/Bevacizumab for Advanced Bronchioloalveolar Carcinoma or Never Smokers With Advanced Non-Small-cell Lung Cancer: SWOG S0635 and S0636 Trials. Clinical lung cancer. 2018 Jan;19(1):84-92. Epub 2017 Jul 6. PMID: 28801183
  • Pagel JM, Othus M, Garcia-Manero G, Fang M, Radich JP, Rizzieri DA, Marcucci G, Strickland SA, Litzow MR, Savoie ML, Spellman SR, Confer DL, Chell JW, Brown M, Medeiros BC, Sekeres MA, Lin TL, Uy GL, Powell BL, Bayer RL, Larson RA, Stone RM, Claxton D, Essell J, Luger SM, Mohan SR, Moseley A, Erba HP, Appelbaum FR. Rapid Donor Identification Improves Survival in High-Risk First-Remission Patients With Acute Myeloid Leukemia. JCO oncology practice. 2020 Jun;16(6):e464-e475. Epub 2020 Jan 27. PMID: 32048933
  • Persky DO, Li H, Rimsza LM, Barr PM, Popplewell LL, Bane CL, Von Gehr A, LeBlanc M, Fisher RI, Smith SM, Friedberg JW. A phase I/II trial of vorinostat (SAHA) in combination with rituximab-CHOP in patients with newly diagnosed advanced stage diffuse large B-cell lymphoma (DLBCL): SWOG S0806. American journal of hematology. 2018 Aug;93(4):486-493. Epub 2018 Jan 25. PMID: 29266344
  • Ailawadhi S, Sexton R, Lentzsch S, Abidi MH, Voorhees PM, Cohen AD, Rohren EM, Heitner S, Kelly K, Mackler NJ, Baer DM, Hoering A, Durie B, Orlowski RZ. Low-dose versus High-dose Carfilzomib with Dexamethasone (S1304) in Patients with Relapsed-Refractory Multiple Myeloma. Clinical cancer research : an official journal of the American Association for Cancer Research. 2020 Aug 1;26(15):3969-3978. Epub 2020 Apr 16. PMID: 32299820
  • Moore HC, Unger JM, Phillips KA, Boyle F, Hitre E, Porter D, Francis PA, Goldstein LJ, Gomez HL, Vallejos CS, Partridge AH, Dakhil SR, Garcia AA, Gralow J, Lombard JM, Forbes JF, Martino S, Barlow WE, Fabian CJ, Minasian L, Meyskens FL Jr, Gelber RD, Hortobagyi GN, Albain KS, POEMS/S0230 Investigators. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. The New England journal of medicine. 2015 Mar 5;372(10):923-32. PMID: 25738668
  • Aggarwal C, Redman MW, Lara PN Jr, Borghaei H, Hoffman P, Bradley JD, Newman AJ 3rd, Feldman MJ, Minichiello K, Miao J, Mack PC, Papadimitrakopoulou VA, Herbst RS, Kelly K, Gandara DR. SWOG S1400D (NCT02965378), a Phase II Study of the Fibroblast Growth Factor Receptor Inhibitor AZD4547 in Previously Treated Patients With Fibroblast Growth Factor Pathway-Activated Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy). Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2019 Oct;14(10):1847-1852. Epub 2019 Jun 11. PMID: 31195180
  • Goldberg SB, Redman MW, Lilenbaum R, Politi K, Stinchcombe TE, Horn L, Chen EH, Mashru SH, Gettinger SN, Melnick MA, Herbst RS, Baumgart MA, Miao J, Moon J, Kelly K, Gandara DR. Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of EGFR-Mutant Non-Small-Cell Lung Cancer: Final Results From SWOG S1403. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2020 Dec 1;38(34):4076-4085. Epub 2020 Oct 6. PMID: 33021871
  • Shadman M, Li H, Rimsza L, Leonard JP, Kaminski MS, Braziel RM, Spier CM, Gopal AK, Maloney DG, Cheson BD, Dakhil S, LeBlanc M, Smith SM, Fisher RI, Friedberg JW, Press OW. Continued Excellent Outcomes in Previously Untreated Patients With Follicular Lymphoma After Treatment With CHOP Plus Rituximab or CHOP Plus 131I-Tositumomab: Long-Term Follow-Up of Phase III Randomized Study SWOG-S0016. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2018 Mar 1;36(7):697-703. Epub 2018 Jan 22. PMID: 29356608
  • Borghaei H, Redman MW, Kelly K, Waqar SN, Robert F, Kiefer GJ, Stella PJ, Minichiello K, Gandara DR, Herbst RS, Papadimitrakopoulou VA. SWOG S1400A (NCT02154490): A Phase II Study of Durvalumab for Patients With Previously Treated Stage IV or Recurrent Squamous Cell Lung Cancer (Lung-MAP Sub-study). Clinical lung cancer. 2021 May;22(3):178-186. Epub 2020 Nov 10. PMID: 33358401
  • Yao JC, Guthrie KA, Moran C, Strosberg JR, Kulke MH, Chan JA, LoConte N, McWilliams RR, Wolin EM, Mattar B, McDonough S, Chen H, Blanke CD, Hochster HS. Phase III Prospective Randomized Comparison Trial of Depot Octreotide Plus Interferon Alfa-2b Versus Depot Octreotide Plus Bevacizumab in Patients With Advanced Carcinoid Tumors: SWOG S0518. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2017 May 20;35(15):1695-1703. Epub 2017 Apr 6. PMID: 28384065
  • Wagner LI, Zhao F, Goss PE, Chapman JW, Shepherd LE, Whelan TJ, Mattar BI, Bufill JA, Schultz WC, LaFrancis IE, Nagargoje GG, Vemuri R, Nikcevich DA, Sledge GW, Cella D. Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03). Breast cancer research and treatment. 2018 Jun;169(3):537-548. Epub 2018 Feb 17. PMID: 29455298
  • Lara PN Jr, Moon J, Hesketh PJ, Redman MW, Williamson SK, Akerley WL 3rd, Hirsch FR, Mack PC, Gandara DR. SWOG S0709: Randomized Phase II Trial of Erlotinib versus Erlotinib Plus Carboplatin/Paclitaxel in Patients with Advanced Non-Small Cell Lung Cancer and Impaired Performance Status as Selected by a Serum Proteomics Assay. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2016 Mar;11(3):420-5. Epub 2015 Dec 25. PMID: 26725184
  • Atkins MB, Lee SJ, Chmielowski B, Tarhini AA, Cohen GI, Truong TG, Moon HH, Davar D, O'Rourke M, Stephenson JJ, Curti BD, Urba WJ, Brell JM, Funchain P, Kendra KL, Ikeguchi AP, Jaslowski A, Bane CL, Taylor MA, Bajaj M, Conry RM, Ellis RJ, Logan TF, Laudi N, Sosman JA, Crockett DG, Pecora AL, Okazaki IJ, Reganti S, Chandra S, Guild S, Chen HX, Streicher HZ, Wolchok JD, Ribas A, Kirkwood JM. Combination Dabrafenib and Trametinib Versus Combination Nivolumab and Ipilimumab for Patients With Advanced BRAF-Mutant Melanoma: The DREAMseq Trial-ECOG-ACRIN EA6134. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2023 Jan 10;41(2):186-197. Epub 2022 Sep 27. PMID: 36166727
  • Barton DL, Atherton PJ, Satele DV, Qin R, Dakhil S, Pipe T, Hobday T, Fee-Schroeder K, Loprinzi CL. A randomized phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances: NCCTG N07C4 (Alliance). Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2020 Dec;28(12):6085-6094. Epub 2020 Apr 19. PMID: 32307658
  • Ahmed A, Deng W, Tew W, Bender D, Mannel RS, Littell RD, DeNittis AS, Edelson M, Morgan M, Carlson J, Darus CJ, Fleury AC, Modesitt S, Olawaiye A, Evans A, Fleming GF. Pre-operative assessment and post-operative outcomes of elderly women with gynecologic cancers, primary analysis of NRG CC-002: An NRG oncology group/gynecologic oncology group study. Gynecologic oncology. 2018 Aug;150(2):300-305. Epub 2018 May 26. PMID: 29807694
  • Chung V, McDonough S, Philip PA, Cardin D, Wang-Gillam A, Hui L, Tejani MA, Seery TE, Dy IA, Al Baghdadi T, Hendifar AE, Doyle LA, Lowy AM, Guthrie KA, Blanke CD, Hochster HS. Effect of Selumetinib and MK-2206 vs Oxaliplatin and Fluorouracil in Patients With Metastatic Pancreatic Cancer After Prior Therapy: SWOG S1115 Study Randomized Clinical Trial. JAMA oncology. 2017 Apr 1;3(4):516-522. PMID: 27978579
  • Herbst RS, Redman MW, Kim ES, Semrad TJ, Bazhenova L, Masters G, Oettel K, Guaglianone P, Reynolds C, Karnad A, Arnold SM, Varella-Garcia M, Moon J, Mack PC, Blanke CD, Hirsch FR, Kelly K, Gandara DR. Cetuximab plus carboplatin and paclitaxel with or without bevacizumab versus carboplatin and paclitaxel with or without bevacizumab in advanced NSCLC (SWOG S0819): a randomised, phase 3 study. The Lancet. Oncology. 2018 Jan;19(1):101-114. Epub 2017 Nov 20. PMID: 29169877
  • Nahleh ZA, Barlow WE, Hayes DF, Schott AF, Gralow JR, Sikov WM, Perez EA, Chennuru S, Mirshahidi HR, Corso SW, Lew DL, Pusztai L, Livingston RB, Hortobagyi GN. SWOG S0800 (NCI CDR0000636131): addition of bevacizumab to neoadjuvant nab-paclitaxel with dose-dense doxorubicin and cyclophosphamide improves pathologic complete response (pCR) rates in inflammatory or locally advanced breast cancer. Breast cancer research and treatment. 2016 Aug;158(3):485-95. Epub 2016 Jul 8. PMID: 27393622
  • Stephens DM, Li H, LeBlanc ML, Puvvada SD, Persky D, Friedberg JW, Smith SM. Continued Risk of Relapse Independent of Treatment Modality in Limited-Stage Diffuse Large B-Cell Lymphoma: Final and Long-Term Analysis of Southwest Oncology Group Study S8736. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2016 Sep 1;34(25):2997-3004. Epub 2016 Jul 5. PMID: 27382104
  • Flaig TW, Tangen CM, Daneshmand S, Alva A, Lerner SP, Lucia MS, McConkey DJ, Theodorescu D, Goldkorn A, Milowsky MI, Bangs R, MacVicar GR, Bastos BR, Fowles JS, Gustafson DL, Plets M, Thompson IM Jr. A Randomized Phase II Study of Coexpression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Bladder Cancer (SWOG S1314; NCT02177695). Clinical cancer research : an official journal of the American Association for Cancer Research. 2021 May 1;27(9):2435-2441. Epub 2021 Feb 10. PMID: 33568346
  • Edelman MJ, Redman MW, Albain KS, McGary EC, Rafique NM, Petro D, Waqar SN, Minichiello K, Miao J, Papadimitrakopoulou VA, Kelly K, Gandara DR, Herbst RS. SWOG S1400C (NCT02154490)-A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy). Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2019 Oct;14(10):1853-1859. Epub 2019 Jul 11. PMID: 31302234
  • Aghajanian C, Filiaci V, Dizon DS, Carlson JW, Powell MA, Secord AA, Tewari KS, Bender DP, O'Malley DM, Stuckey A, Gao J, Dao F, Soslow RA, Lankes HA, Moore K, Levine DA. A phase II study of frontline paclitaxel/carboplatin/bevacizumab, paclitaxel/carboplatin/temsirolimus, or ixabepilone/carboplatin/bevacizumab in advanced/recurrent endometrial cancer. Gynecologic oncology. 2018 Aug;150(2):274-281. Epub 2018 May 24. PMID: 29804638
  • Algazi AP, Othus M, Daud AI, Lo RS, Mehnert JM, Truong TG, Conry R, Kendra K, Doolittle GC, Clark JI, Messino MJ, Moore DF Jr, Lao C, Faller BA, Govindarajan R, Harker-Murray A, Dreisbach L, Moon J, Grossmann KF, Ribas A. Continuous versus intermittent BRAF and MEK inhibition in patients with BRAF-mutated melanoma: a randomized phase 2 trial. Nature medicine. 2020 Oct;26(10):1564-1568. Epub 2020 Oct 5. PMID: 33020646
  • Garcia-Manero G, Podoltsev NA, Othus M, Pagel JM, Radich JP, Fang M, Rizzieri DA, Marcucci G, Strickland SA, Litzow MR, Savoie ML, Medeiros BC, Sekeres MA, Lin TL, Uy GL, Powell BL, Kolitz JE, Larson RA, Stone RM, Claxton D, Essell J, Luger SM, Mohan SR, Moseley A, Appelbaum FR, Erba HP. A randomized phase III study of standard versus high-dose cytarabine with or without vorinostat for AML. Leukemia. 2024 Jan;38(1):58-66. Epub 2023 Nov 7. PMID: 37935977
  • Yoon HH, Ou FS, Soori GS, Shi Q, Wigle DA, Sticca RP, Miller RC, Leenstra JL, Peller PJ, Ginos B, Heying E, Wu TT, Drevyanko TF, Ko S, Mattar BI, Nikcevich DA, Behrens RJ, Khalil MF, Kim GP, Alberts SR. Induction versus no induction chemotherapy before neoadjuvant chemoradiotherapy and surgery in oesophageal adenocarcinoma: a multicentre randomised phase II trial (NCCTG N0849 [Alliance]). European journal of cancer (Oxford, England : 1990). 2021 Jun;150:214-223. Epub 2021 Apr 29. PMID: 33934058
  • Halfdanarson TR, Foster NR, Kim GP, Haddock MG, Dakhil SR, Behrens RJ, Alberts SR. N064A (Alliance): Phase II Study of Panitumumab, Chemotherapy, and External Beam Radiation in Patients with Locally Advanced Pancreatic Adenocarcinoma. The oncologist. 2022 Jul 5;27(7):534-e546. PMID: 35285484
  • Heinrich MC, Rankin C, Blanke CD, Demetri GD, Borden EC, Ryan CW, von Mehren M, Blackstein ME, Priebat DA, Tap WD, Maki RG, Corless CL, Fletcher JA, Owzar K, Crowley JJ, Benjamin RS, Baker LH. Correlation of Long-term Results of Imatinib in Advanced Gastrointestinal Stromal Tumors With Next-Generation Sequencing Results: Analysis of Phase 3 SWOG Intergroup Trial S0033. JAMA oncology. 2017 Jul 1;3(7):944-952. PMID: 28196207
  • Chan JK, Deng W, Higgins RV, Tewari KS, Bonebrake AJ, Hicks M, Gaillard S, Ramirez PT, Chafe W, Monk BJ, Aghajanian C. A phase II evaluation of brivanib in the treatment of persistent or recurrent carcinoma of the cervix: An NRG Oncology/Gynecologic Oncology Group study. Gynecologic oncology. 2017 Sep;146(3):554-559. Epub 2017 Jul 18. PMID: 28728751
  • Chou SS, Romanoff J, Lehman CD, Khan SA, Carlos R, Badve SS, Xiao J, Corsetti RL, Javid SH, Spell DW, Han LK, Sabol JL, Bumberry JR, Gareen IF, Snyder BS, Gatsonis C, Wagner LI, Wolff AC, Miller KD, Sparano JA, Comstock CE, Rahbar H. Preoperative Breast MRI for Newly Diagnosed Ductal Carcinoma in Situ: Imaging Features and Performance in a Multicenter Setting (ECOG-ACRIN E4112 Trial). Radiology. 2021 Oct;301(1):66-77. Epub 2021 Aug 3. PMID: 34342501