Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 2/2009

01-07-2009 | Original Article

A phase II study of gemcitabine in combination with oxaliplatin as first-line chemotherapy in patients with inoperable biliary tract cancer

Authors: Hyun Jung Kim, Nam Su Lee, Sang-Cheol Lee, Sang Byung Bae, Chan Kyu Kim, Young Gook Cheon, Young Seok Kim, Jong Ho Moon, Young Deok Cho, Sang Heum Park, Kyu Taek Lee, Sung Kyu Park, Jong-Ho Won, Hee Sook Park, Dae Sik Hong

Published in: Cancer Chemotherapy and Pharmacology | Issue 2/2009

Login to get access

Abstract

Purpose

The aim of this study is to investigate the efficacy and safety of gemcitabine and oxaliplatin combination chemotherapy as first-line therapy in patients with inoperable biliary tract cancer (BTC).

Methods

The treatment of this non-randomized phase II study consisted of gemcitabine 1,000 mg/m2 intravenously (i.v.) on day 1 and oxaliplatin 85 mg/m2 i.v. on day 2 every 2 weeks until disease progression, unaccep toxicity or patients’ refusal.

Results

From Sept 2006 to Oct 2007, 40 patients were enrolled. In the ITT analysis, the objective response rate was 15.0% and the disease control rate was 52.5%. The median overall survival (95% CI) was 8.5 months (6.4–10.7) and the time to progression was 4.2 months (0.5–7.9). For the 305 cycles, observed grade 3/4 toxicity was uncommon.

Conclusions

Gemcitabine and dose adjusted oxaliplatin combination chemotherapy had moderate anti-tumor activity and was well tolerated as a first-line treatment for patients with inoperable BTC.
Literature
1.
Shin HR, Jung KW, Won YJ, Park JG (2004) 2002 annual report of the Korea central cancer registry: based on registered data from 139 hospitals. Cancer Res Treat 36:103–114CrossRefPubMed
2.
Bartlett DL, Ramanathan RK, Deutsch M (2005) Cancer of the biliary tree. In: DeVita VT, Hellman S, Rosenberg SA (eds) CANCER principle and practice of oncology, 7th edn. Lippincott Williams & Wilkins, Philadelphia, pp 1009–1035
3.
Glimelius B, Hoffman K, Sjödén PO et al (1996) Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol 7:593–600PubMed
4.
Patt YZ, Jones DV Jr, Hoque A et al (1996) Phase II trail of intravenous fluorouracil and subcutaneous interferon alfa-2b for biliary tract cancer. J Clin Oncol 14:2311–2315PubMed
5.
Choi CW, Choi IK, Seo JH et al (2000) Effects of 5-fluorouracil and leucovorin in the treatment of pancreatic-biliary tract adenocarcinomas. Am J Clin Oncol 23:425–428PubMedCrossRef
6.
Ducreux M, Van Cutsem E, Van Laethem JL et al (2005) A randomised phase II trial of weekly high-dose 5-fluorouracil with and without folinic acid and cisplatin in patients with advanced biliary tract carcinoma: results of the 40955 EORTC trial. Eur J Cancer 41:398–403PubMedCrossRef
7.
Ducreux M, Rougier P, Fandi A et al (1998) Effective treatment of advanced biliary tract carcinoma using 5-fluorouracil continuous infusion with cisplatin. Ann Oncol 9:653–656PubMedCrossRef
8.
Penz M, Kornek GV, Raderer MU et al (2001) Phase II trial of two-weekly gemcitabine in patients with advanced biliary tract cancer. Ann Oncol 12:183–186PubMedCrossRef
9.
Gallardo JO, Rubio B, Fodor M et al (2001) A phase II study of gemcitabine in gallbladder carcinoma. Ann Oncol 12:1403–1406PubMedCrossRef
10.
Harder J, Riecken B, Kummer O et al (2006) Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer. Br J Cancer 95:848–852PubMedCrossRef
11.
Kim ST, Park JO, Lee J et al (2006) A phase II study of gemcitabine and cisplatin in advanced biliary tract cancer. Cancer 106:1339–1346PubMedCrossRef
12.
Park BK, Kim YJ, Park JY et al (2006) Phase II study of gemcitabine and cisplatin in advanced biliary tract cancer. J Gastroenterol Hepatol 21:999–1003PubMedCrossRef
13.
Murad AM, Guimaraes RC, Aragao BC et al (2003) Phase II trial of the use of gemcitabine and 5-fluorouracil in the treatment of advanced pancreatic and biliary tract cancer. Am J Clin Oncol 26:151–154PubMedCrossRef
14.
Lee J, Kim TY, Lee MA et al (2008) Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas. Cancer Chemother Pharmacol 61:47–52PubMedCrossRef
15.
Faivre S, Raymond E, Woynarowski JM, Cvitkovic E (1999) Suppraadditive effect of 2′, 2′- difluorodeoxycytidine (gemcitabine) in combination with oxaliplatin in human cancer cell lines. Cancer Chemother Pharmacol 44:117–123PubMedCrossRef
16.
André T, Tournigand C, Rosmorduc O et al (2004) Gemcitabine and combined with oxliplatin (GEMOX) in advanced biliary tract adenocarcinoma: a GERCOR study. Ann Oncol 15:1339–1343PubMedCrossRef
17.
Louvet C, André T, Lledo G et al (2002) Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma: final results of a GERCOR multicenter phase II study. J Clin Oncol 20:1512–1518PubMedCrossRef
18.
Airoldi M, Cattel L, Passera R, Pedani F, Milla P, Zanon C (2006) Gemcitabine and oxaliplatin in patients with pancreatic adenocarcinoma: clinical and pharmacokinetic data. Pancreas 32:44–50PubMedCrossRef
19.
Louvet C, Labianca R, Hammel P et al (2005) Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol 23:3509–3516PubMedCrossRef
20.
Eklund JW, Trifilio S, Mulcahy MF (2005) Chemotherapy dosing in the setting of liver dysfunction. Oncology (Williston Park) 19:1057–1063
21.
Tempero M, Plunkett W, Ruiz Van Haperen V et al (2003) Randomized phase II comparison of dose-intense gemcitabine: Thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma. J Clin Oncol 21:3402–3408PubMedCrossRef
22.
Abbruzzese JL, Grunewald R, Weeks EA et al (1991) A phase I clinical, plasma, and cellular pharmacology study of gemcitabine. J Clin Oncol 9:491–498PubMed
23.
Guan Z, Wang Y, Maoleekoonpairoj S et al (2003) Prospective randomised phase II study of gemcitabine at standard or fixed dose rate schedule in unresectable hepatocellular carcinoma. Br J Cancer 89:1865–1869PubMedCrossRef
24.
Gridelli C, Gallo C, Ceribelli A et al (2007) Factorial phase III randomised trial of rofecoxib and prolonged constant infusion of gemcitabine in advanced non-small-cell lung cancer: the GEmcitabine-COxib in NSCLC(GECO) study. Lancet Oncol 8:500–512PubMedCrossRef
25.
Taïeb J, Bonyhay L, Golli L et al (2003) Gemcitabine plus oxaliplatin for patients with advanced hepatocellular carcinoma using two different schedules. Cancer 98:2664–2670PubMedCrossRef
26.
Eckel F, Schmid RM (2007) Chemotherapy in advanced biliary tract carcinoma: a pooled analysis of clinical trials. Br J Cancer 96:896–902PubMedCrossRef
27.
Yonemoto N, Furuse J, Okusaka T et al (2007) A multi-center retrospective analysis of survival benefits of chemotherapy for unresectable biliary tract cancer. Jpn J Clin Oncol 37:843–851PubMedCrossRef
28.
Doval DC, Sekhon JS, Gupta SK et al (2004) A phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer. Br J Cancer 90:1516–1520PubMedCrossRef
29.
Knox JJ, Hedley D, Oza A et al (2005) Combining gemcitabine and capecitabine in patients with advanced biliary cancer: a phase II trial. J Clin Oncol 23:2332–2338PubMedCrossRef
30.
André T, Reyes-Vidal JM, Fartoux L et al (2008) Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study. Br J Cancer 99:862–867PubMedCrossRef
31.
Fink D, Aebi S, Howell SB (1998) The role of DNA mismatch repair in drug resistance. Clin Cancer Res 4:1–6PubMed
32.
Kohya N, Kitajima Y, Kitahara K, Miyazaki K (2003) Mutation analysis of K-ras and beta-catenin genes related to O6-methylguanin-DNA methyltransferase and mismatch repair protein status in human gallbladder carcinoma. Int J Mol Med 11:65–69PubMed
33.
Adlard JW, Richman SD, Seymour MT, Quirke P (2002) Prediction of the response of colorectal cancer to systemic therapy. Lancet Oncol 3:75–82PubMedCrossRef
34.
van Ruiz Haperen VW, Veerman G, Eriksson S et al (1994) Development and molecular characterization of a 2′, 2′-difluorodeoxycytidine-resistant variant of the human ovarian carcinoma cell line A2780. Cancer Res 54:4138–4143
Metadata
Title
A phase II study of gemcitabine in combination with oxaliplatin as first-line chemotherapy in patients with inoperable biliary tract cancer
Authors
Hyun Jung Kim
Nam Su Lee
Sang-Cheol Lee
Sang Byung Bae
Chan Kyu Kim
Young Gook Cheon
Young Seok Kim
Jong Ho Moon
Young Deok Cho
Sang Heum Park
Kyu Taek Lee
Sung Kyu Park
Jong-Ho Won
Hee Sook Park
Dae Sik Hong
Publication date
01-07-2009
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 2/2009
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-008-0883-7

Other articles of this Issue 2/2009

Cancer Chemotherapy and Pharmacology 2/2009 Go to the issue

Original Article

Impact of body composition on pharmacokinetics of doxorubicin in children: a Glaser Pediatric Research Network study

Original Article

Disposition of desipramine, a sensitive cytochrome P450 2D6 substrate, when coadministered with intravenous temsirolimus

Short Communication

A phase I dose escalation study of the pharmacokinetics and tolerability of ZK 304709, an oral multi-targeted growth inhibitor (MTGI™), in patients with advanced solid tumours

Erratum

Topoisomerase I and IIα protein expression in primary colorectal cancer and recurrences following 5-fluorouracil-based adjuvant chemotherapy

Original Article

Phase II study of capecitabine and trastuzumab combination chemotherapy in patients with HER2 overexpressing metastatic breast cancers resistant to both anthracyclines and taxanes

Original Article

Changes of host immunity in relation to efficacy in liver cirrhosis patients with advanced hepatocellular carcinoma treated by intra-arterial chemotherapy
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine
Image Credits