Gemcitabine and S-1 for Advanced Biliary Tract Cancer

NCT02146703 | Completed Phase 2

• 1 other identifier: HMC-HO-GI-0501
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study will conduct a phase II study of gemcitabine and S-1 as first-line chemotherapy in patient with advanced biliary tract cancer

Conditions

Biliary Tract Neoplasm

Keywords

biliary tract neoplasm; gemcitabine; S-1

Outcome Measures

Primary Outcomes (1)

• Objective reponse rate

  1 year

Secondary Outcomes (1)

• Progression free survival, median overall survival, disease control rate, and over grade 3 hematologic toxicities (neutropenia, thrombocytopenia, and febrile neutropenia)

  1 year

Study Arms (1)

gemcitabine and S-1

EXPERIMENTAL

Drug: Gemcitabine, and S-1

Interventions

Gemcitabine, and S-1 DRUG

Treatment will be delivered as a 3-week cycle. 1. Gemcitabine 1000 mg/m2 iv on day 1, 8 2. S-1 60 mg/day po on day 1-14

Also known as: Gemzar, TS-1

gemcitabine and S-1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable, locally advanced, metastatic adenocarcinoma arising from the intra- and extrahepatic biliary ducts or gallbladder
• Initially diagnosed or recurred
• At least one bidimensionally measurable lesion, defined as at least 1x1cm with clearly defined margins on physical examination, on 3-dimentional CT, MRI, or PET-CT
• Age ≥18 and ≤70 years
• Estimated life expectancy ≥3 months
• ECOG performance status ≤2
• Adequate bone marrow function (WBCs ≥4,000/µL or absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL),
• Adequate kidney function (creatinine ≤1.4 mg/dL)
• Adequate liver function (bilirubin ≤1.8 mg/dL, transaminase levels ≤100mg/dL)
• Written informed consent

You may not qualify if:

• Other tumor type than adenocarcinoma
• Previous history of chemotherapy (exception : adjuvant chemotherapy)
• Presence of CNS metastasis, psychosis, or seizure
• Obvious bowel obstruction
• Evidence of serious gastrointestinal bleeding
• Past or concurrent history of neoplasm other than biliary adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception
• Other serious illness or medical conditions

Sponsors & Collaborators

• Hallym University Medical Center: lead
• Jeil Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Hallym University Medical Center

Anyang, South Korea

Location

Related Publications (12)

• Oertli D, Herzog U, Tondelli P. Primary carcinoma of the gallbladder: operative experience during a 16 year period. Eur J Surg. 1993 Aug;159(8):415-20.

  PMID: 8218552 BACKGROUND

• de Groen PC, Gores GJ, LaRusso NF, Gunderson LL, Nagorney DM. Biliary tract cancers. N Engl J Med. 1999 Oct 28;341(18):1368-78. doi: 10.1056/NEJM199910283411807. No abstract available.

  PMID: 10536130 BACKGROUND

• Thongprasert S. The role of chemotherapy in cholangiocarcinoma. Ann Oncol. 2005;16 Suppl 2:ii93-6. doi: 10.1093/annonc/mdi712. No abstract available.

  PMID: 15958484 BACKGROUND

• Hezel AF, Zhu AX. Systemic therapy for biliary tract cancers. Oncologist. 2008 Apr;13(4):415-23. doi: 10.1634/theoncologist.2007-0252.

  PMID: 18448556 BACKGROUND

• Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

  PMID: 20375404 BACKGROUND

• Shirasaka T, Shimamato Y, Ohshimo H, Yamaguchi M, Kato T, Yonekura K, Fukushima M. Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anticancer Drugs. 1996 Jul;7(5):548-57. doi: 10.1097/00001813-199607000-00010.

  PMID: 8862723 BACKGROUND

• Ueno H, Okusaka T, Ikeda M, Takezako Y, Morizane C. Phase II study of S-1 in patients with advanced biliary tract cancer. Br J Cancer. 2004 Nov 15;91(10):1769-74. doi: 10.1038/sj.bjc.6602208.

  PMID: 15505626 BACKGROUND

• Furuse J, Okusaka T, Boku N, Ohkawa S, Sawaki A, Masumoto T, Funakoshi A. S-1 monotherapy as first-line treatment in patients with advanced biliary tract cancer: a multicenter phase II study. Cancer Chemother Pharmacol. 2008 Oct;62(5):849-55. doi: 10.1007/s00280-007-0673-7. Epub 2008 Jan 23.

  PMID: 18214482 BACKGROUND

• Sasaki T, Isayama H, Nakai Y, Ito Y, Kogure H, Togawa O, Toda N, Yasuda I, Hasebe O, Maetani I, Sasahira N, Hirano K, Tsujino T, Tada M, Omata M. Multicenter, phase II study of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer. Cancer Chemother Pharmacol. 2010 May;65(6):1101-7. doi: 10.1007/s00280-009-1115-5. Epub 2009 Aug 26.

  PMID: 19707761 BACKGROUND

• Kanai M, Yoshimura K, Tsumura T, Asada M, Suzuki C, Niimi M, Matsumoto S, Nishimura T, Nitta T, Yasuchika K, Taura K, Mori Y, Hamada A, Inoue N, Tada S, Yanagihara K, Yazumi S, Osaki Y, Chiba T, Ikai I, Fukushima M, Uemoto S, Hatano E. A multi-institution phase II study of gemcitabine/S-1 combination chemotherapy for patients with advanced biliary tract cancer. Cancer Chemother Pharmacol. 2011 Jun;67(6):1429-34. doi: 10.1007/s00280-010-1443-5. Epub 2010 Sep 2.

  PMID: 20811895 BACKGROUND

• Sasaki T, Isayama H, Nakai Y, Ito Y, Yasuda I, Toda N, Kogure H, Hanada K, Maguchi H, Sasahira N, Kamada H, Mukai T, Okabe Y, Hasebe O, Maetani I, Koike K. A randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine monotherapy for advanced biliary tract cancer. Cancer Chemother Pharmacol. 2013 Apr;71(4):973-9. doi: 10.1007/s00280-013-2090-4. Epub 2013 Jan 26.

  PMID: 23355041 BACKGROUND

• Morizane C, Okusaka T, Mizusawa J, Takashima A, Ueno M, Ikeda M, Hamamoto Y, Ishii H, Boku N, Furuse J. Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: a Japan Clinical Oncology Group trial (JCOG 0805). Cancer Sci. 2013 Sep;104(9):1211-6. doi: 10.1111/cas.12218. Epub 2013 Jul 25.

  PMID: 23763511 BACKGROUND

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine; S 1 (combination); titanium silicide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Dae Young Zang, MD, PhD

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 26, 2014
• Study Start: August 1, 2005
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2013
• Last Updated: May 26, 2014

Record last verified: 2014-05

Locations

KR (1)