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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Hertz, Daniel L; Owzar, Kouros; Lessans, Sherrie et al. (2016) Pharmacogenetic Discovery in CALGB (Alliance) 90401 and Mechanistic Validation of a VAC14 Polymorphism that Increases Risk of Docetaxel-Induced Neuropathy. Clin Cancer Res 22:4890-4900
Hatch, Ace J; Sibley, Alexander B; Starr, Mark D et al. (2016) Blood-based markers of efficacy and resistance to cetuximab treatment in metastatic colorectal cancer: results from CALGB 80203 (Alliance). Cancer Med 5:2249-60
Martin, Linda W; D'Cunha, Jonathan; Wang, Xiaofei et al. (2016) Detection of Occult Micrometastases in Patients With Clinical Stage I Non-Small-Cell Lung Cancer: A Prospective Analysis of Mature Results of CALGB 9761 (Alliance). J Clin Oncol 34:1484-91
Freedman, Rachel A; Seisler, D K; Foster, J C et al. (2016) Risk of acute myeloid leukemia and myelodysplastic syndrome among older women receiving anthracycline-based adjuvant chemotherapy for breast cancer on Modern Cooperative Group Trials (Alliance A151511). Breast Cancer Res Treat :
Flaherty, Keith T; Manola, Judith B; Pins, Michael et al. (2015) BEST: A Randomized Phase II Study of Vascular Endothelial Growth Factor, RAF Kinase, and Mammalian Target of Rapamycin Combination Targeted Therapy With Bevacizumab, Sorafenib, and Temsirolimus in Advanced Renal Cell Carcinoma--A Trial of the ECOG-ACRIN C J Clin Oncol 33:2384-91
Wang, Xiaofei; Gu, Lin; Zhang, Ying et al. (2015) Validation of survival prognostic models for non-small-cell lung cancer in stage- and age-specific groups. Lung Cancer 90:281-7
Lilenbaum, Rogerio; Samuels, Michael; Wang, Xiaofei et al. (2015) A phase II study of induction chemotherapy followed by thoracic radiotherapy and erlotinib in poor-risk stage III non-small-cell lung cancer: results of CALGB 30605 (Alliance)/RTOG 0972 (NRG). J Thorac Oncol 10:143-7
Patel, Jai N; Jiang, Chen; Hertz, Daniel L et al. (2015) Bevacizumab and the risk of arterial and venous thromboembolism in patients with metastatic, castration-resistant prostate cancer treated on Cancer and Leukemia Group B (CALGB) 90401 (Alliance). Cancer 121:1025-31
Rugo, Hope S; Barry, William T; Moreno-Aspitia, Alvaro et al. (2015) Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N0 J Clin Oncol 33:2361-9
Voorhees, Peter M; Orlowski, Robert Z; Mulkey, Flora et al. (2015) Long-term outcomes for newly-diagnosed multiple myeloma patients treated with pegylated liposomal doxorubicin and bortezomib: final results of CALGB (Alliance) 10301, a multicentre phase II study. Br J Haematol 171:373-7

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