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

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291615
• Other study ID #: KHBO1003
• Secondary ID: UMIN000004682
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2011
• Last updated: October 21, 2014
• Start date: December 2010
• Est. completion date: May 2013

Study information

• Verified date: October 2014
• Source: Kansai Hepatobiliary Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

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
• 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.

Locations

Country	Name	City	State
Japan	Osaka University, Graduate School of Medicine	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Kansai Hepatobiliary Oncology Group

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kobayashi S, Nagano H, Sakai D, Eguchi H, Hatano E, Kanai M, Seo S, Taura K, Fujiwara Y, Ajiki T, Takemura S, Kubo S, Yanagimoto H, Toyokawa H, Tsuji A, Terajima H, Morita S, Ioka T. Phase I study of adjuvant gemcitabine or S-1 in patients with biliary tract cancers undergoing major hepatectomy: KHBO1003 study. Cancer Chemother Pharmacol. 2014 Oct;74(4):699-709. doi: 10.1007/s00280-014-2543-4. Epub 2014 Jul 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency in adverse events	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.	up to 12 weeks	Yes