Phase i clinical trial of temsirolimus and vinorelbine in advanced solid tumors

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

Research output: Contribution to journalArticlepeer-review

7 Scopus citations


Purpose: To 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. Methods: Patients 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. Results: Nineteen 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. Conclusions: Temsirolimus 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.

Original languageEnglish (US)
Pages (from-to)1227-1234
Number of pages8
JournalCancer Chemotherapy and Pharmacology
Issue number6
StatePublished - Dec 2014


  • Metastatic carcinoma
  • Phase I trial
  • Temsirolimus
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)


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