Duke University Medical Center is currently completing its fourth grant cycle as a member of Cancer and Leukemia Group B (CALGB). Over the last two decades, Duke has consistently been one of the top five institutions in overall patient accrual. The goal and specific aims of the current application are to continue this high level of patient enrollment, combined with broad scientific participation by our faculty in the development of treatment trials and correlative science studies. An additional aim is to further develop our clinical trials organization by providing broad access to cancer clinical trials, not only at Duke, but also in underserved communities of North Carolina and research affiliates across the Southeast United States through our Duke Oncology Network (DON). In the current grant cycle, 866 patients were enrolled at Duke and nearly 1900 patients across the DON. This high level of clinical commitment to CALGB activities is matched by a high level of scientific participation by Duke Faculty. Particular areas of strength include Breast Cancer and Correlative Studies, Cancer in the Elderly, Leukemia/Lymphoma and Respiratory Cancer and Thoracic Surgery. Faculty recruitment has expanded our strength in all of these areas, as well as provided major growth in Gl and GU cancer programs. Duke faculty have made substantial contributions in CALGB biomarker based studies and genomic based treatment trials. To improve regulatory oversight and efficient use of resources, Duke cancer clinical trials have been reorganized into an Oncology Site Based Research (SBR) entity within the Cancer Center which includes CALGB activities. The SBR/ CALGB oversees disease and site specific clinical research teams at Duke and throughout DON, which includes 10 community sites in North Carolina, staffed by Duke faculty and research nurses, as well as 11 research affiliate sites. This organizational structure has been developed over the last 20 years under the direction of Dr. Jeffrey Crawford, who serves as the Principal Investigator of CALGB activities. Activities at Duke are further enhanced by the close interaction with the CALGB biostatistics and data management center headquartered at Duke, under the direction of Dr. Stephen George, who is also Director of Biostatistics at the Duke Comprehensive Cancer Center. In the next grant cycle, we propose to utilize these resources to further increase our patient enrollment on cooperative group clinical trials, enhance our scientific participation within the group and expand access to clinical trials for underserved populations.

Public Health Relevance

Participation of patients and investigators in cooperative group clinical trials is vital to our understanding of the biology and treatment of cancer. Continued support of both CALGB activities and Duke University's participation in them will enable continued patient enrollment and scientific participation in cancer clinical trials of national importance.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Study Section
Subcommittee G - Education (NCI)
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Mooney, Margaret M
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Duke University
Internal Medicine/Medicine
Schools of Medicine
United States
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Smith, Matthew R; Halabi, Susan; Ryan, Charles J et al. (2014) Randomized controlled trial of early zoledronic acid in men with castration-sensitive prostate cancer and bone metastases: results of CALGB 90202 (alliance). J Clin Oncol 32:1143-50
Shulman, Lawrence N; Berry, Donald A; Cirrincione, Constance T et al. (2014) Comparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (Alliance). J Clin Oncol 32:2311-7
Rizzieri, David A; Johnson, Jeffrey L; Byrd, John C et al. (2014) Improved efficacy using rituximab and brief duration, high intensity chemotherapy with filgrastim support for Burkitt or aggressive lymphomas: cancer and Leukemia Group B study 10 002. Br J Haematol 165:102-11
Walker, Alison; Mrozek, Krzysztof; Kohlschmidt, Jessica et al. (2013) New recurrent balanced translocations in acute myeloid leukemia and myelodysplastic syndromes: cancer and leukemia group B 8461. Genes Chromosomes Cancer 52:385-401
Lewis, Lionel D; Miller, Antonius A; Owzar, Kouros et al. (2013) The relationship of polymorphisms in ABCC2 and SLCO1B3 with docetaxel pharmacokinetics and neutropenia: CALGB 60805 (Alliance). Pharmacogenet Genomics 23:29-33
Aggarwal, Rahul; Halabi, Susan; Kelly, William Kevin et al. (2013) The effect of prior androgen synthesis inhibition on outcomes of subsequent therapy with docetaxel in patients with metastatic castrate-resistant prostate cancer: results from a retrospective analysis of a randomized phase 3 clinical trial (CALGB 90401) ( Cancer 119:3636-43
Schwind, Sebastian; Edwards, Colin G; Nicolet, Deedra et al. (2013) inv(16)/t(16;16) acute myeloid leukemia with non-type A CBFB-MYH11 fusions associate with distinct clinical and genetic features and lack KIT mutations. Blood 121:385-91
Roberts, Andrew S; Campa, Michael J; Gottlin, Elizabeth B et al. (2012) Identification of potential prognostic biomarkers in patients with untreated, advanced pancreatic cancer from a phase 3 trial (Cancer and Leukemia Group B 80303). Cancer 118:571-8
Edelman, Martin J; Hodgson, Lydia; Rosenblatt, Paula Y et al. (2012) CYFRA 21-1 as a prognostic and predictive marker in advanced non-small-cell lung cancer in a prospective trial: CALGB 150304. J Thorac Oncol 7:649-54
Romanus, Dorothy; Kindler, Hedy L; Archer, Laura et al. (2012) Does health-related quality of life improve for advanced pancreatic cancer patients who respond to gemcitabine? Analysis of a randomized phase III trial of the cancer and leukemia group B (CALGB 80303). J Pain Symptom Manage 43:205-17

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