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Phase II studies of two different schedules of dasatinib in bone metastasis predominant metastatic breast cancer: SWOG S0622
Abstract Bone metastases from breast cancer are common, causing significant morbidity. Preclinical data of dasatinib, an oral small molecule inhibitor of multiple oncogenic tyrosine kinases, uggested efficacy in tumor control and palliation of bone metastases in metastatic breast cancer (MBC). This clinical trial aimed to determine whether treatment with either of 2 dose schedules of […]
Assessing Clinical Trial-Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool.
Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial-associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings.
Why the "Moon Shot" to Cure Cancer Might Work
The Wall Street Journal Dr. Atul Grover (@AtulGroverMD) is the chief public policy officer of the Association of American Medical College Widespread praise for Vice President Joseph Biden’s “Moon Shot to Cure Cancer“ is another positive development in a year that could prove transformative for biomedical research – and the nation. In December, biomedical research […]
Chemotherapy-induced nausea and vomiting: incidence and characteristics of persistent symptoms and future directions NCCTG N08C3 (Alliance).
We recently performed an unplanned secondary analysis on a previously reported negative phase III trial (N08C3) looking at the efficacy of gabapentin/placebo in combination with dexamethasone and a 5HT3 receptor antagonist in the prevention of CINV for 413 patients undergoing regimens with highly emetogenic chemotherapy (HEC). In the current study, we attempted to better understand the higher than expected rate of overall patient satisfaction, despite a low complete response rate in both arms. Additionally, we looked at patient variables and their relationship to rates of CINV.
Phase II trial of R-CHOP plus bortezomib induction therapy
Mantle cell lymphoma (MCL) is a distinct subtype of B cell non-Hodgkin lymphoma characterised by the CCND1/IGH (t[11;14]) translocation leading to overexpression of cyclin D1. Although the survival of patients with MCL has improved over the last decade, much of this benefit is associated with selected populations of younger patients receiving intensive therapy (Delarue et […]
Cooperative Group Trials in the Community Setting
Over the last 40 years the National Cancer Institute (NCI) has created a vibrant public-private partnership for the implementation of NCI-sponsored cooperative group (Network) clinical trials throughout the United States and Canada. Over these four decades, the cancer clinical trials process has become more complex more precise and more resource intensive. During this same time […]
ECOG-ACRIN opens NCI-MATCH precision medicine cancer trial
The largest, most scientifically rigorous precision medicine trial in cancer to date is now open to cancer centers and community hospitals nationwide. As the largest precision medicine trial for cancer to date, NCI-MATCH seeks to determine whether matching certain drugs or drug combinations to people whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of their cancer type. Treatment for this trial focuses on molecular abnormalities of patient tumors instead of the organ sites of the cancer.
Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle
PURPOSE: We compared nab-paclitaxel or ixabepilone once per week to paclitaxel with bevacizumab as first-line therapy for patients with advanced breast cancer (BC) to evaluate progression-free survival (PFS) for nab-paclitaxel or ixabepilone versus paclitaxel. PATIENTS AND METHODS: Eligible patients were age ≥ 18 years with chemotherapy-naive advanced BC. Patients were randomly assigned to bevacizumab with […]
Randomized Multicenter Placebo for the Control of Aromatase Inhibitor
Purpose Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors (AIs) and can result in decreased quality of life and discontinuation of therapy. Omega-3 fatty acids (O3-FAs) can be effective in decreasing arthralgia resulting from rheumatologic conditions and reducing serum triglycerides. Patients and Methods Women with early-stage breast cancer receiving an AI who […]
Methods to Standardize a Multicenter Acupuncture Trial Protocol
Robust methods are needed to efficiently conduct large, multi-site, randomized controlled clinical trials of acupuncture protocols. SWOG S1200 is a randomized, controlled sham- and waitlist-controlled trial of a standardized acupuncture protocol treating aromatase inhibitor (AI)-associated arthralgias in early stage breast cancer patients (n=228).
