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

Oncology
D SantiniGiuseppe Tonini

Abstract

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. 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). 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 n...Continue Reading

References

Mar 1, 1991·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·J L AbbruzzeseM N Raber
Aug 1, 1996·Annals of Oncology : Official Journal of the European Society for Medical Oncology·B GlimeliusC Svensson
Jun 1, 1997·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·H A BurrisD D Von Hoff
Dec 16, 1998·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·M MiwaH Ishitsuka
Oct 28, 1999·The New England Journal of Medicine·P C de GroenD M Nagorney
Apr 13, 2001·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M PenzW Scheithauer
Jan 5, 2002·Annals of Oncology : Official Journal of the European Society for Medical Oncology·J O GallardoM Ahumada
Jun 22, 2002·Annals of Oncology : Official Journal of the European Society for Medical Oncology·J Rudi
Aug 31, 2002·Investigational New Drugs·Roger KuhnKarsten Ridwelski
Sep 3, 2002·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·P Therasse
Mar 5, 2004·Annals of Oncology : Official Journal of the European Society for Medical Oncology·G V KornekW Scheithauer
Dec 4, 2004·American Journal of Clinical Oncology·Cathy EngHedy L Kindler
Feb 5, 2005·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·M DucreuxUNKNOWN EORTC Gastro Intestinal Tract Cancer Group
Apr 1, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jennifer J KnoxMalcolm J Moore
Jan 10, 2006·Seminars in Oncology·Hedy Lee Kindler
Jul 1, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Philip A PhilipCharles Erlichman
Dec 5, 2006·Cancer Chemotherapy and Pharmacology·Yong Sang HongWon Ki Kang
Dec 13, 2006·Annals of Oncology : Official Journal of the European Society for Medical Oncology·D SantiniG Tonini
Feb 28, 2007·British Journal of Cancer·F Eckel, R M Schmid
Jun 29, 2007·Digestive Diseases and Sciences·Jeffrey A MeyerhardtCharles S Fuchs
Jul 14, 2007·Cancer·Rachel P RiechelmannJennifer J Knox
Jan 25, 2008·Cancer Chemotherapy and Pharmacology·Junji FuruseAkihiro Funakoshi
May 2, 2008·The Oncologist·Aram F Hezel, Andrew X Zhu
Jan 27, 2009·Cancer Chemotherapy and Pharmacology·Ramesh K RamanathanDavid R Gandara
Jan 30, 2009·Journal of Gastroenterology and Hepatology·Jeong-Ok LeeYung-Jue Bang
Feb 25, 2009·British Journal of Cancer·T AndréW Scheithauer
Jul 4, 2009·Cancer Chemotherapy and Pharmacology·Atul SharmaGoura Rath
Apr 9, 2010·The New England Journal of Medicine·Juan ValleUNKNOWN ABC-02 Trial Investigators

❮ Previous
Next ❯

Citations

Nov 26, 2014·Cancer Chemotherapy and Pharmacology·Tadashi UwagawaKatsuhiko Yanaga
Feb 20, 2021·ANZ Journal of Surgery·Marianne F T WietsmaThomas J Hugh
Apr 17, 2021·Critical Reviews in Oncology/hematology·Alexander A AziziJuan W Valle

❮ Previous
Next ❯

Related Concepts

Related Feeds

Carcinoma, Basal Cell

Basal cell carcinoma is a form of malignant skin cancer found on the head and neck regions and has low rates of metastasis. Discover the latest research on basal cell carcinoma here.

Anemia

Anemia develops when your blood lacks enough healthy red blood cells. Anemia of inflammation (AI, also called anemia of chronic disease) is a common, typically normocytic, normochromic anemia that is caused by an underlying inflammatory disease. Here is the latest research on anemia.