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Biliary Tract NeoplasmPhase 2NCT02146703

Gemcitabine and S-1 for Advanced Biliary Tract Cancer

A Phase 2 study testing Gemcitabine, and S-1 in people with Biliary Tract Neoplasm, run by Hallym University Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Biliary Tract Neoplasm
What is being tested?
Gemcitabine, and S-1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteSouth Korea
Study dates
Aug 2005to Dec 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Hallym University Medical Center

    Anyang

Other trials in South Korea

About this study

Official title: Phase II Trial of Gemcitabine and S-1 for Patients With Advanced Biliary Tract Cancer

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

Read the detailed description

Biliary-tract cancer (BTC) is invasive carcinoma that originates from the epithelial lining of the gallbladder and bile ducts. BTC include cholangiocarcinoma (intrahepatic, perihilar, and distal biliary-tree tumor) and carcinoma arising from the gallbladder.

Surgical resection of the primary tumor is potentially curative for BTC, but less than a quarter of patients are eligible for resection at presentation. Systemic chemotherapy is the principal treatment method for patients with unresectable or metastatic BTC.

Gemcitabine is a promising agent, which has shown efficacy in biliary tract cancer. As a single-agent therapy, gemcitabine shows response rates of 8-36% in BTC[4]. In phase II trials with patients in advanced BTC, gemcitabine in combination with capecitabine or platinum analogues produced objective response rates of 26-50%.

The ABC-02 study reported a significant survival advantage for gemcitabine and cisplatin over gemcitabine alone in patients with advanced BTC (median overall survival 11.7 vs. 8.1 months; P < 0.001).

Oral anticancer drug S-1 consists of the 5-FU prodrug tegafur with two biochemical modulators, 5-chloro-2,4-dihydroxypyridine (CDHP) and potassium oxonate (Oxo). S-1 monotherapy is active against advanced BTC with objective response rates of 21-35%, and phase II trials of S-1 in combination with gemcitabine reported objective response rates of 20-36%. Differences between trials in the doses and administration schedules of gemcitabine and S-1 may be reflected in the ranges of efficacy, dose-intensity, and rates of toxicity observed.

Even though the efficacy of gemcitabine and S-1 combination is evident for patients with advanced BTC in previous phase II trials, there was no clinical study investigating the efficacy of gemcitabine and S-1 combination for patients with advanced BTC when this study was started. Therefore, we conducted a phase II study to evaluate gemcitabine and S-1 combination as first-line chemotherapy for patients with advanced BTC.

Being tested
Gemcitabine, and S-1
Keywords
biliary tract neoplasm, gemcitabine, S-1
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gemcitabine, and S-1Drug

    Also called Gemzar, TS-1

    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
Study groups in NCT02146703
Study groupRoleWhat they receive
gemcitabine and S-1ExperimentalNot described
Receives: Drug: Gemcitabine, and S-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective reponse rate

    Measured: 1 year

Secondary outcomes (1)

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2014 (estimated)
  2. Study startAug 2005
  3. Primary completionNov 2010
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02146703
Sponsor's protocol ID
HMC-HO-GI-0501
Status last verified
May 2014
First submitted
19 May 2014
Last updated
26 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 8218552

  • 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.

    PubMed 10536130

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

    PubMed 15958484

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

    PubMed 18448556

  • 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.

    PubMed 20375404

  • 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.

    PubMed 8862723

  • 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.

    PubMed 15505626

  • 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.

    PubMed 18214482

  • 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.

    PubMed 19707761

  • 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.

    PubMed 20811895

  • 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.

    PubMed 23355041

  • 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.

    PubMed 23763511

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, and S-1 in people with Biliary Tract Neoplasm, run by Hallym University Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective reponse rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02146703, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014.

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