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

NCT01291615 | Completed Phase 1 DMC

• 2 other identifiers: KHBO1003UMIN000004682
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Gemcitabine group

EXPERIMENTAL

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

S-1 group

EXPERIMENTAL

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

Interventions

Gemcitabine DRUG

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

Also known as: gemzer

Gemcitabine group

S-1 DRUG

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

Also known as: TS-1

S-1 group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biliary tract cancer (\>= UICC Stage IB)
• R0 or R1 resection due to biliary tract cancer (BTC)
• ECOG performance status must be 0 or 1
• The patient underwent no other treatment than surgery for BTC
• 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.
• The patient can intake drugs per os.
• From 4 to 12 weeks after the surgery
• Written informed consent

You may not qualify if:

• Existence of active double cancer
• The patient suffered from severe drug allergy
• Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
• Any active infections exist.
• Pregnancy
• Severe mental disorder
• Others

Sponsors & Collaborators

• Kansai Hepatobiliary Oncology Group: lead

Study Sites (1)

Osaka University, Graduate School of Medicine

Osaka, 565-0871, Japan

Location

Related 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.

  PMID: 25074036 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

• Hiroaki Nagano, MD, PhD

  Osaka University Graduate School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: February 8, 2011
• Study Start: December 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: May 1, 2013
• Last Updated: October 23, 2014

Record last verified: 2014-10

Locations

JP (1)