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Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer

Sponsor
Kansai Hepatobiliary Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT01291615
Collaborator
(none)
6
Enrollment
1
Location
2
Arms
29
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant therapy after hemihepatectomy

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

There is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer, because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy. For example, our preliminary results showed that regular gemcitabine administration (1000mg/m2, day1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced severe leukocytopenia and/or thrombocytopenia. Herein, we planned this study to decide more safety adjuvant protocol(recommend dose) for gemcitabine and S-1 after hemihepatectomy using continual reassessment method analysis. In this study, we decided that tolerable ratio of dose-limiting toxicity would be less than 10%.

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gemcitabine group

800mg/m2 - 1000mg/m2, day 1 every 3 weeks. day 1, 15 every 4 weeks. day 1, 8 every 3 weeks. day 1, 8, 15, every 4 weeks

Drug: Gemcitabine
800mg/m2 - 1000mg/m2, day 1 every 3 weeks. day 1, 15 every 4 weeks. day 1, 8 every 3 weeks. day 1, 8, 15, every 4 weeks
Other Names:
  • gemzer

    		•
    Experimental: S-1 group

    S-1 40mg/day - 120mg/day (depend on body surface area) day 1-14, every 3 weeks day 1-28, every 6 weeks

    Drug: S-1
    S-1 40mg/day - 120mg/day (depend on body surface area) day 1-14, every 3 weeks day 1-28, every 6 weeks.
    Other Names:
  • TS-1

    		•

    Outcome Measures

    Primary Outcome Measures

    1. frequency in adverse events [up to 12 weeks]

      The purpose of this study is to decide maximum tolerated dose and recommended dose. Recommended dose is a dose which would induce dose-limiting toxicity in 10% of participants. This will be calculated by continual reassessment method.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Biliary tract cancer (>= UICC Stage IB)

    2. R0 or R1 resection due to biliary tract cancer (BTC)

    3. ECOG performance status must be 0 or 1

    4. The patient underwent no other treatment than surgery for BTC

    5. Neutrophil must be over 1500/μl, platelet must be over 100,000/μl, AST and ALT must be less than five times the normal limit, total bilirubin must be less than three times the normal limit, and creatinin must be less than 1.2 mg/dl.

    6. The patient can intake drugs per os.

    7. From 4 to 12 weeks after the surgery

    8. Written informed consent

    Exclusion Criteria:

    1. Existence of active double cancer

    2. The patient suffered from severe drug allergy

    3. Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)

    4. Any active infections exist.

    5. Pregnancy

    6. Severe mental disorder

    7. Others

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Osaka University, Graduate School of Medicine Osaka Japan 565-0871

    Sponsors and Collaborators

    • Kansai Hepatobiliary Oncology Group

    Investigators

    • Study Director: Hiroaki Nagano, MD, PhD, Osaka University Graduate School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kansai Hepatobiliary Oncology Group
    ClinicalTrials.gov Identifier:
    NCT01291615
    Other Study ID Numbers:
    • KHBO1003
    • UMIN000004682
    First Posted:
    Feb 8, 2011
    Last Update Posted:
    Oct 23, 2014
    Last Verified:
    Oct 1, 2014
    Additional relevant MeSH terms:
    Biliary Tract Neoplasms
    Gemcitabine

    Study Results

    No Results Posted as of Oct 23, 2014