Phase II study of docetaxel in patients with pancreatic cancer previously untreated with cytotoxic chemotherapy.

In this study, we estimated the response rate, duration of response, and type, severity and reversibility of toxicities in patients with Stage IV adenocarcinoma of the pancreas treated with docetaxel. Twenty-one patients with locally advanced or metastatic pancreatic cancer, previously untreated or treated with surgery or radiation alone, were treated with 100 mg/m2 docetaxel as a 1 hr infusion once every 21 days. All the patients were pretreated with dexamethasone and diphenhydramine. Twenty patients were assessable for both response and toxicity. One patient was assessable for toxicity alone. However, all the patients were assessed for survival. The major side effect of the drug was neutropenia, which required a dose reduction to 75 mg/m2 in approximately half of the patients. Nine patients were hospitalized with neutropenic fever. Fluid retention was not a significant problem. One patient had a partial response lasting for 21 weeks and 7 patients had stable disease. The remaining patients had progressive disease. The median survival for all the patients was 5.9 months. Docetaxel as a single agent showed limited activity against adenocarcinoma of the pancreas. Since the completion of this study, molecular predictors of in vitro response to docetaxel have been described. Confirmation of the clinical relevance of such predictors in humans could allow for the identification of a subgroup of patients with a higher rate of response to docetaxel.