Phase I clinical trial of temsirolimus and vinorelbine in advanced solid tumors View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2014-11-06

AUTHORS

Caroline I. Piatek, Grace L. Raja, Lingyun Ji, Barbara Jennifer Gitlitz, Tanya B. Dorff, David I. Quinn, James Hu, Anthony B. El-Khoueiry, Huyen Q. Pham, Lynda Roman, Agustin A. Garcia

ABSTRACT

PurposeTo determine the maximal tolerated dose (MTD) of the combination of weekly temsirolimus and every other week vinorelbine in patients with advanced or refractory solid tumors.MethodsPatients were treated with intravenous temsirolimus on days 1, 8, 15, and 22 and intravenous vinorelbine on days 1 and 15. Cycles were repeated every 28 days. ResultsNineteen patients were enrolled in the study. Tumor types included lung (5), prostate (2), neuroendocrine of pancreas (1), bladder (2), uterus (3), cervix (4), and vagina (2). All patients had received prior chemotherapy. Four patients were enrolled to dose level I, nine to dose level II, and six to dose level III. Six patients were inevaluable and replaced. Fifty-seven total cycles were administered. There was 1 dose-limiting toxicity at level II (grade 3 anorexia/dehydration) and 2 at level III (grade 3 hypokalemia; grade 4 neutropenia). Two patients died at dose level III; one was study-related with grade 4 neutropenia. Grade 3/4 toxicities observed during the first cycle included neutropenia (2), anemia (1), anorexia (1), dehydration (1), hyperglycemia (1), hypertriglyceridemia (1), and hypokalemia (1). Best response included two patients (prostate and non-small cell lung cancer) with partial response and eight patients with stable disease with median duration of best response of 3.2 months.ConclusionsTemsirolimus 25 mg given days 1, 8, 15, and 22 in combination with vinorelbine 20 mg/m2 given days 1 and 15 every 4 weeks was found to be the MTD. This dose combination is considered feasible in phase II trials. More... »

PAGES

1227-1234

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00280-014-2600-z

DOI

http://dx.doi.org/10.1007/s00280-014-2600-z

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1024008051

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/25374407


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62 hyperglycemia
63 hypertriglyceridemia
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74 neuroendocrine
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76 pancreas
77 partial response
78 patients
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81 prior chemotherapy
82 prostate
83 refractory solid tumors
84 response
85 solid tumors
86 stable disease
87 study
88 temsirolimus
89 total cycles
90 toxicity
91 trials
92 tumor types
93 tumors
94 types
95 uterus
96 vagina
97 vinorelbine
98 weekly temsirolimus
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