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A family of covariance models for longitudinal counts with predictive covariates is presented. These models account for overdispersion, heteroscedasticity, and dependence among repeated observations. The approach is a quasi-likelihood regression similar to the formulation given by Liang and Zeger (1986, Biometrika 73, 13-22). Generalized estimating(More)
PURPOSE Gemcitabine as a single agent and the combination of gemcitabine and docetaxel have activity in patients with metastatic soft tissue sarcoma. To determine if the addition of docetaxel to gemcitabine improved clinical outcome of patients with metastatic soft tissue sarcomas, we compared a fixed dose rate infusion of gemcitabine versus a lower dose of(More)
We present a Bayesian approach for monitoring multiple outcomes in single-arm clinical trials. Each patient's response may include both adverse events and efficacy outcomes, possibly occurring at different study times. We use a Dirichlet-multinomial model to accommodate general discrete multivariate responses. We present Bayesian decision criteria and(More)
We present an adaptive Bayesian method for dose-finding in phase I/II clinical trials based on trade-offs between the probabilities of treatment efficacy and toxicity. The method accommodates either trinary or bivariate binary outcomes, as well as efficacy probabilities that possibly are nonmonotone in dose. Doses are selected for successive patient cohorts(More)
In oncology, a patient's treatment often involves multiple courses of chemotherapy. The most common medical practice in choosing treatments for successive courses is to repeat a treatment that is successful in a given course and otherwise switch to a different treatment. Patient outcome thus consists of a sequence of dependent response variables and(More)
PURPOSE To further assess preclinical and early clinical evidence that imatinib mesylate, a platelet-derived growth factor receptor (PDGFR) inhibitor, modulates taxane activity in prostate cancer and bone metastases, a randomized study was conducted. EXPERIMENTAL DESIGN Men with progressive castration-resistant prostate cancer with bone metastases (n =(More)
PURPOSE Currently, treatment recommendations for small-cell urothelial cancer (SCUC) are based on anecdotal case reports and small retrospective series. We now report results from the first phase II clinical trial developed exclusively for SCUC, to our knowledge. PATIENTS AND METHODS From 2001 to 2006, 30 patients with SCUC provided consent and were(More)
PURPOSE Clinical features characteristic of small-cell prostate carcinoma (SCPC), "anaplastic," often emerge during the progression of prostate cancer. We sought to determine the efficacy of platinum-based chemotherapy in patients meeting at least one of seven prospectively defined "anaplastic" clinical criteria, including exclusive visceral or(More)
We propose a design strategy for single-arm clinical trials in which the goals are to find a dose of an experimental treatment satisfying both safety and efficacy requirements, treat a sufficiently large number of patients to estimate the rates of these events at the selected dose with a given reliability, and stop the trial early if it is likely that no(More)