Phase II trial of sequential paclitaxel and 1 h infusion of bryostatin-1 in patients with advanced esophageal cancer

Geoffrey Y. Ku, David H. Ilson, Lawrence H. Schwartz, Marinela Capanu, Eileen O'Reilly, Manish A. Shah, David P. Kelsen, Gary K. Schwartz

Research output: Contribution to journalArticlepeer-review

44 Scopus citations


Background: We sought to determine the response rate and toxicity profile of sequential paclitaxel and bryostatin-1, a novel, selective inhibitor of protein kinase C, in patients with advanced esophageal cancer. Patients and methods: Patients with advanced esophageal and gastroesophageal junction cancer were enrolled. All gave informed consent. They were initially treated with paclitaxel 90 mg/m2 intravenously on Day 1 and bryostatin-1 50 μg/m2 on Day 2 weekly for three consecutive weeks out of four. Because of severe myalgias, dosing was reduced to paclitaxel 80 mg/m2 with bryostatin-1 40 μg/m2 and then to paclitaxel 80 mg/m 2 with bryostatin-1 25 μg/m2. Results: Twenty-four patients were enrolled, with 22 assessable for response. The partial response rate was 27%. 10 patients treated with bryostatin-1 40-50 μg/m2 had a response rate of 40 versus 17% at bryostatin-1 25 μg/m2 (p-value = 0.3). Median time-to-progression was 3.7 months and median survival was 8.3 months. Grade 3/4 myalgias were seen in 50% of patients. Myalgias appeared to be related to bryostatin-1 dose. Because of toxicity, the trial was closed prior to full accrual. Conclusions: Despite potential anti-tumor activity of this combination in patients with advanced esophageal cancer, further development is not warranted, given the severe toxicity, especially myalgias, that were seen.

Original languageEnglish
Pages (from-to)875-880
Number of pages6
JournalCancer Chemotherapy and Pharmacology
Issue number5
StatePublished - Oct 2008
Externally publishedYes


  • Bryostatin-1
  • Esophageal cancer
  • Gastroesophageal cancer
  • Paclitaxel
  • Protein kinase C


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