Phase II trial of carboplatin, gemcitabine, and capecitabine in patients with carcinoma of unknown primary site.
BACKGROUND
The purposes of this study were to evaluate efficacy and toxicity of the combination of carboplatin, gemcitabine, and capecitabine in patients with carcinoma of unknown primary site (CUP).


METHODS
Patients with CUP received carboplatin AUC 5 mg/mL a minute intravenously Day 1, gemcitabine 1000 mg/m(2) intravenously Days 1 and 8, and capecitabine 1600 mg/m(2) orally in divided doses, Days 1-14 of a 21-day cycle for up to 8 cycles. The primary endpoint of the study was objective response rate by intent-to-treat analysis.


RESULTS
Thirty-three patients were treated (median age, 58 years; men:women ratio, 19:14). Most patients had a baseline performance status of 1. The objective response rate was 39.4% (95% CI, 22.9%-57.9%) in all patients, 36.4% in 22 patients with well to moderately differentiated adenocarcinoma, and 40.0% in 20 patients with liver metastases. Median progression-free survival time was 6.2 months (95% CI, 5.4%-8.0%), and median survival time was 7.6 months (95% CI, 6.3-14.1). One and 2-year survival rates were 35.6% and 14.2%, respectively. The most frequent grade > or =3 adverse events were neutropenia (67%), thrombocytopenia (48%), and anemia (33%).


CONCLUSIONS
The combination of carboplatin, gemcitabine, and capecitabine is active in CUP, especially in patients with liver metastases. This regimen may be a potential therapy for CUP patients with good performance status, particularly those with a suspected origin below the diaphragm.
Schneider
Bryan J
BJ
Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI 48109-0848, USA. bryansch@umich.edu
El-Rayes
Basil
B
Muler
Jeffery H
JH
Philip
Philip A
PA
Kalemkerian
Gregory P
GP
Griffith
Kent A
KA
Zalupski
Mark M
MM
D000008:Abdominal Neoplasms / Q000188:drug therapy / Q000556:secondary; D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002272:Carcinoembryonic Antigen / Q000097:blood; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D053208:Kaplan-Meier Estimate; D007970:Leukopenia / Q000139:chemically induced; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009382:Neoplasms, Unknown Primary / Q000097:blood / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D016896:Treatment Outcome; D000093542:Gemcitabine
D002272:Carcinoembryonic Antigen; D003841:Deoxycytidine; D000069287:Capecitabine; D016190:Carboplatin; D005472:Fluorouracil; D000093542:Gemcitabine