Community Clinical Oncology Program

项目来源

美国卫生和人类服务部基金(HHS)

项目主持人

SMITH, WENDY B.

项目受资助机构

MAYO CLINIC

立项年度

2005

立项时间

未公开

项目编号

3U10CA037404-21S1

项目级别

国家级

研究期限

未知 / 未知

受资助金额

5066.00美元

学科

未公开

学科代码

未公开

基金类别

未公开

关键词

未公开

参与者

LOPRINZI, CHARLES L

参与机构

NATIONAL CANCER INSTITUTE

项目标书摘要:DESCRIPTION: (Applicant's Description) The Mayo Clinic, through the vehicle of the North Central Cancer Treatment Group (NCCTG), will serve as a primary research base for the following 15 CCOPs: Ann Arbor Regional CCOP, Carle Cancer Center CCOP, Cedar Rapids Oncology Project CCOP, Des Moines CCOP, Duluth CCOP, Merit Care Hospital CCOP, Geisinger CCOP, Metro Minnesota CCOP, Missouri Valley Cancer Consortium CCOP, Ochsner Clinic CCOP, Illinois Oncology Research Association CCOP, Scottsdale CCOP, Siouxland Community Cancer Consortium CCOP, Toledo CCOP, and the Wichita CCOP. We will also serve as a research base for cancer control protocol activity of non-CCOP participants and for the multiple CCOPs outside of our group who contribute to intergroup cancer treatment and cancer control protocols which we lead. We will cooperate with our affiliated CCOPs in planning their program and in conducting appropriate continuing education and workshops. We will provide training and active support for their data managers and oncology nurses. We will coordinate their multidisciplinary involvement in clinical cancer research protocols. This will include evolving and maintaining standard reporting procedures for surgery, pathology, and radiation therapy. We will hold regular meetings of the CCOPs for review of ongoing research, planning future research, and for related professional activities. We will continue the rigid quality control procedures which have proved so successful in the past, and upgrade these procedures as indicated. We will constantly monitor CCOP performance not only by timely review of patients, data sheets, pathology material, operative reports, and radiation therapy port films, but also by periodic randomly scheduled monitoring site visits. We will work with each CCOP participant to aid in their maturation as clinical investigators. We will assist them in developing new protocols for which they will share leadership, and we will work with them in preparing publications as well as presentations for national and regional meetings. We will make every effort to provide them with justifiable pride in their participation in the National Cancer Program. A high priority over this grant period will be the further expansion of our cancer control efforts with incorporation of associated basic laboratory support, leading to scientifically rigorous translational research efforts.

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  • 1.Randomized phase II study of two irinotecan schedules for patients with metastatic breast cancer refractory to an anthracycline, a taxane, or both

    • 关键词:
    • PHARMACOKINETIC TRIAL; FLUOROURACIL FAILURE; VINORELBINE; CAPECITABINE;MULTICENTER; PACLITAXEL; INFUSION; CPT-11; CAMPTOTHECIN; GEMCITABINE
    • Perez, EA;Hillman, DW;Mailliard, JA;Ingle, JN;Ryan, JM;Fitch, TR;Rowland, KM;Kardinal, CG;Krook, JE;Kugler, JW;Dakhil, SR
    • 《39th Annual Meeting of the American-Society-of-Clinical-Oncology 》
    • 2004年
    • MAY 31-JUN 03, 2003
    • Chicago, IL
    • 会议

    Purpose A pressing need exists for agents active against anthracycline- or taxane-refractory metastatic breast cancer (MBC), or both. Previous clinical trials suggested that irinotecan might have such activity. We conducted this multicenter phase II study to assess efficacy and tolerability of two irinotecan schedules.Patients and Methods MBC patients who experienced disease progression after one to three chemotherapy regimens, including at least one anthracycline- or taxane-based regimen, were randomly assigned to irinotecan in 6-week cycles comprising 100 mg/m(2) weekly for 4 weeks, then a 2-week rest (weekly) or 240 mg/m(2) every 3 weeks.Results The weekly arm had 52 assessable patients; the every-3-weeks arm had 51 assessable patients. In the weekly arm, the objective response (complete regression [CR] + partial regression [PR]) rate was 23% (one CR, 11 PR; 95% CI, 13% to 37%). Median response duration was 4.9 months (range, 1.9 to 15.9 months), and median overall survival was 9.7 months (95% CI, 8.0 to 14.2 months). In the every-3-weeks arm, the objective response rate was 14% (nine PR; 95% CI, 6% to 26%), median response duration was 4.2 months (range, 3.1 to 13.9 months), and median overall survival was 8.6 months (95% CI, 7.0 to 12.3 months). Treatment generally was well tolerated, especially in the weekly arm. Grade 3 to 4 adverse events with greater than or equal to 10% incidence included neutropenia (29%) and diarrhea (17%) in the weekly arm and neutropenia (36%), vomiting (20%), dyspnea (18%), nausea (16%), and diarrhea (12%) in the every-3-weeks arm.Conclusion Irinotecan is active with good tolerability in refractory MBC. Irinotecan (especially weekly) warrants additional study as monotherapy and in combination regimens in this setting. (C) 2004 by American Society of Clinical Oncology.

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