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Abstract
The purpose of this study was to evaluate the activity ofsingle-agent gemcitabine in previously treated patients with carcinoma ofunknown primary site. Between January 1997 and October 1998, 39 patients wereenrolled in this multicenter Phase II trial performed in the Minnie PearlCancer Research Network. Twenty-seven patients (69%) had adenocarcinoma orpoorly differentiated adenocarcinoma; 35 patients (90%) had previously receivedtreatment with chemotherapy regimens containing both a platinum agent anda taxane. Only 21% of patients had ever responded to previous therapy. Gemcitabine1000 mg/m2 was administered intravenously on days1, 8, and 15 of each 28-day course. Three of 36 evaluable patients (8%) hadpartial responses, and 9 patients (25%) had minor responses or stable diseasewith improved symptoms. The median time to progression for patients with partialresponses or stable disease/improved symptoms was 5 months. Treatment waswell tolerated, with uncommon grade 3 or 4 toxicity. Gemcitabine produceda low objective response rate in this refractory patient population, althoughapproximately one-third of patients experienced symptomatic improvement. Treatmentwith gemcitabine was well tolerated. Because gemcitabine has activity againsta variety of adenocarcinomas, further evaluation of this agent as part offirst-line therapy for patients with carcinoma of unknown primary site isappropriate.