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

• Published in: Cancer investigation Vol. 19; no. 4; pp. 335 - 339
• Main Authors: Hainsworth, John D., Burris, Howard A., Calvert, Sharon W., Willcutt, Noel T., Scullin, Daniel C., Bramham, Jane, Greco, F. Anthony
• Format: Journal Article
• Language: English
• Published: New York, NY Informa UK Ltd 2001; Taylor & Francis; Informa Healthcare
• Subjects: Adenocarcinoma - drug therapy; Adult; Aged; Antimetabolites, Antineoplastic - administration & dosage; Antimetabolites, Antineoplastic - adverse effects; Antimetabolites, Antineoplastic - therapeutic use; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - pharmacology; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma of unknown primary site; Chemotherapy; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Disease-Free Survival; Drug Resistance, Neoplasm; Female; Gemcitabine; Humans; Infusions, Intravenous; Leukopenia - chemically induced; Male; Medical sciences; Middle Aged; Neoplasms, Unknown Primary - drug therapy; Pharmacology. Drug treatments; Salvage Therapy; Thrombocytopenia - chemically induced; Treatment Outcome; Antineoplastic agent; Human; Carcinoma; Intravenous administration; Gemcitabine; Toxicity; Treatment efficiency; Multicenter study; Malignant tumor; Chemotherapy; Treatment; Phase II trial; Metastatic; Fluorine Organic compounds; Pretreatment; Pyrimidine nucleoside
• ISSN: 0735-7907; 1532-4192
• DOI: 10.1081/CNV-100103127

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.