Gemcitabine in the second-line therapy of patients with carcinoma of unknown primary site: A phase II trial of the Minnie Pearl Cancer Research Network

The purpose of this study was to evaluate the activity of single-agent gemc itabine in previously treated patients with carcinoma of unknown primary si te. Between January 1997 and October 1998, 39 patients were enrolled in thi s multicenter Phase II trial performed in the Minnie Pearl Cancer Research network. Twenty-seven patients (69%) had adenocarcinoma or poorly different iated adenocarcinoma; 35 patients (90%) had previously received treatment w ith chemotherapy regiments containing both a platinum agent and a taxane. O nly 21% of patients had ever responded to previous therapy. Gemcitabine 100 0 mg/m(2) was administered intravenously on days 1, 8, and 15 of each 28-da y course. Three of 36 evaluable patients (8%) had partial responses, and 9 patients (25%) had minor responses or stable disease with improved symptoms . The median time to progression for patients with partial responses or sta ble disease/improved symptoms was 5 months. Treatment was well tolerated, w ith uncommon grade 3 or 4 toxicity. Gemcitabine produced a low objective ra te in this refractory patient population, although approximately one-third of patients experienced symptomatic improvement. Treatment with gemcitabine was well tolerated. Because gemcitabine has activity against a variety of adenocarcinomas, further evaluation of this agent as part of first-line the rapy for patients with carcinoma of unknown primary site is appropriate.