A phase II trial of fixed-dose rate gemcitabine plus capecitabine in metastatic/advanced biliary tract cancer patients.

Abstract

BACKGROUND:

This phase II trial was conducted to determine the activity and safety of the combination of fixed-dose rate (FDR) gemcitabine and capecitabine in metastatic biliary tract cancer (BTC) patients.

METHODS:

Patients with unresectable BTC who had pathologically confirmed adenocarcinoma, no prior chemotherapy, Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and measurable disease were enrolled. Treatment consisted of FDR gemcitabine at 800 mg/m(2) on days 1 and 8 every 21 days with capecitabine administered orally b.i.d. in equal doses (650 mg/m(2) b.i.d.) for 14 days (28 doses).

RESULTS:

Between May 2005 and February 2009, 30 patients were enrolled. The median age was 67 years (45-76) and there were 14 males. Thirty patients were evaluable for response and toxicity. A total of 221 cycles were administered (median 7, range 2-16). One patient achieved complete response and 7 patients achieved partial response, giving an overall response rate of 26.7% in the intention-to-treat population. Twelve patients (40.0%) had stable disease. The median progression-free survival was 6.33 months. The median overall survival was 10.8 months. Grade 3/4 neutropenia and thrombocytopenia were noted in 13 and 7% of the patients, respectively. Grade 2/3 nonhematologic toxicities were asthenia (54% of patients), diarrhea (17%), stomatitis (23%) and hand-foot syndrome (7%). There was no treatment-related death. The drugs taken were skipped at least once in 45% of the patients and the dose was reduced in 26% of them.

CONCLUSIONS:

The combination of FDR gemcitabine and capecitabine in this 3-week cycle is safe and seems to have a good activity in advanced biliary cancer.

• Authors: Daniele Santini, Vladimir Virzi, Enrico Vasile, Bruno Vincenzi, Vincenzo Catalano, Francesco Graziano, Gianluca Masi, Giuseppe Bronte, Antonio Russo, Alfredo Falcone, Giuseppe Tonini
• Journal: Oncology (Oncology) Vol. 82 Issue 2 Pg. 75-82 ( 2012) ISSN: 1423-0232 [Electronic] Switzerland
• PMID: 22327844 (Publication Type: Clinical Trial, Phase II, Journal Article)
• Copyright: Copyright © 2012 S. Karger AG, Basel.

Chemical References

• Deoxycytidine
• Capecitabine
• Fluorouracil
• Gemcitabine

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Biliary Tract Neoplasms (drug therapy, mortality, pathology)
• Capecitabine
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Disease-Free Survival
• Female
• Fluorouracil (administration & dosage, adverse effects, analogs & derivatives)
• Humans
• Male
• Middle Aged
• Neoplasm Metastasis
• Neoplasm Staging
• Gemcitabine