Journal ArticleDOI
One- and two-stage designs for stratified phase II clinical trials.
Wendy B. London,Myron Chang +1 more
TLDR
Both one- and two-stage tests are developed, and conditional and unconditional approaches are introduced in each case, where the conditional approach involves conditioning on the observed samples sizes within the strata.Abstract:
A global one-sample test for response rates for stratified phase II clinical trials is proposed. Such a test is analogous to that of a stratified log-rank test for time-to-event data. Both one- and two-stage tests are developed, and conditional and unconditional approaches are introduced in each case, where the conditional approach involves conditioning on the observed samples sizes within the strata. The methodology generates samples sizes and stopping boundaries that provide designs with the desired power and type I error probability. These methods are useful for designing stratified phase II clinical trials. An application to a Children's Oncology Group phase II clinical trial in relapsed neuroblastoma patients is presented.read more
Citations
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Journal ArticleDOI
Proper inference from Simon's two-stage designs.
Tatsuki Koyama,Heidi Chen +1 more
TL;DR: A method is presented for inferences using both the planned and the actual sample sizes of Simon's two-stage designs, which usually yield similar P-values and confidence intervals for the response rate.
Journal ArticleDOI
Temsirolimus with or without megestrol acetate and tamoxifen for endometrial cancer: A gynecologic oncology group study
Gini F. Fleming,Virginia L. Filiaci,Brandon Marzullo,Richard J. Zaino,Susan A. Davidson,Michael L. Pearl,Vicky Makker,James J. Burke,Susan Zweizig,Linda Van Le,Parviz Hanjani,Gordon Downey,Joan L. Walker,Henry D. Reyes,Kimberly K. Leslie +14 more
TL;DR: Adding the combination of megestrol acetate and tamoxifen to temsirolimus therapy did not enhance activity and the combination was associated with an excess of venous thrombosis.
Journal ArticleDOI
Comparison of Error Rates in Single-Arm Versus Randomized Phase II Cancer Clinical Trials
Hui Tang,Nathan R. Foster,Axel Grothey,Stephen M. Ansell,Richard M. Goldberg,Daniel J. Sargent +5 more
TL;DR: Variability in historical control success rates, outcome drifts in patient populations over time, and/or patient selection effects can result in inaccurate false-positive and false-negative error rates in single-arm designs, but leave performance of the randomized two-arm design largely unaffected at the cost of 2 to 4 times the sample size compared with single- arm designs.
Journal ArticleDOI
Re‐induction chemoimmunotherapy with epratuzumab in relapsed acute lymphoblastic leukemia (ALL): Phase II results from Children's Oncology Group (COG) study ADVL04P2
Elizabeth A. Raetz,Mitchell S. Cairo,Michael J. Borowitz,Xiaomin Lu,Meenakshi Devidas,Joel M. Reid,David M. Goldenberg,William A. Wegener,Hui Zeng,James A. Whitlock,Peter C. Adamson,Stephen P. Hunger,William L. Carroll +12 more
TL;DR: A phase I/II study is designed to determine whether the addition of epratuzumab (anti‐CD22) to an established chemotherapy platform improves rates of second remission (CR2) in pediatric patients with B‐lymphoblastic leukemia and early bone marrow relapse.
Journal ArticleDOI
Phase II Study of Cisplatin plus Cetuximab in Advanced, Recurrent, and Previously Treated Cancers of the Cervix and Evaluation of Epidermal Growth Factor Receptor Immunohistochemical Expression: A Gynecologic Oncology Group Study
John H. Farley,Michael W. Sill,Michael W. Sill,Michael J. Birrer,Joan L. Walker,Russell J. Schilder,J. Tate Thigpen,Robert L. Coleman,Brigitte Miller,Peter G. Rose,Heather A. Lankes +10 more
TL;DR: The combination of cetuximab with cis Platin was adequately tolerated but did not indicate additional benefit beyond cisplatin therapy.
References
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Journal ArticleDOI
Optimal two-stage designs for phase II clinical trials.
TL;DR: Two-stage designs that are optimal in the sense that the expected sample size is minimized if the regimen has low activity subject to constraints upon the size of the type 1 and type 2 errors are presented.
Journal ArticleDOI
One-Sample Multiple Testing Procedure for Phase II Clinical Trials
TL;DR: A one-sample multiple testing procedure is proposed which employs the standard single-stage test procedure at the last test, and which both allows for early termination and essentially preserves the size, power and simplicity of the single- stage procedure.
Journal ArticleDOI
Designs for group sequential tests
Thomas R. Fleming,Thomas R. Fleming,David P. Harrington,David P. Harrington,Peter C. O'Brien,Peter C. O'Brien +5 more
TL;DR: An alternative procedure is proposed that offers a good opportunity for early termination when initial results are extreme, while essentially maintaining the power provided by the procedure that applies when the corresponding test statistic is computed only at the predetermined time of final analysis.
Journal ArticleDOI
Designs for group sequential phase II clinical trials.
TL;DR: A method to search over a restricted set of designs and to select the optimal one in this set according to optimality criteria is proposed and in all the combinations investigated the optimal design produced by the method is the true global optimum.
Journal ArticleDOI
Group sequential designs using both type I and type II error probability spending functions
TL;DR: In this article, the authors proposed flexible group sequential designs using type I and type II error probability spending functions, which preserve the overall significance level and power and allow the repeated testing to be perloimed at a flexible schedule.