Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer

NCT01284413 | Completed Phase 1 DMC

• 2 other identifiers: KHBO1002UMIN000004468
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety of GCS therapy for phase I and efficacy of GCS therapy for phase II.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• one year survival rate

  The primary endpoint is designated to evaluate overall survival rate at 12-month. Secondary endpoints include response rate according to RECIST 1.1 and the incidence of adverse events evaluated by CTCAE v 4.0.

  2 years

Secondary Outcomes (1)

• Toxicity and response rate

  2 years

Study Arms (1)

S-1, Gemcitabine, Cisplatin

EXPERIMENTAL

Drug: S-1, Gemcitabine, Cisplatin

Interventions

S-1, Gemcitabine, Cisplatin DRUG

S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.

Also known as: S-1;TS-1, Gemcitabine;gemzer, Cisplatin;Cispulan

S-1, Gemcitabine, Cisplatin

Eligibility Criteria

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

You may qualify if:

• \. Patients with cytologically or histologically proved biliary tract cancer 2. age \>=20 years 3. PS 0-2 4. No prior history of chemotherapy or radiotherapy. Patients who have undergone adjuvant chemotherapy are eligible if at least 6 months have passed since the last administration.
• \. Adequate bone marrow function (neutrophil count \>=1,500/mm3, and platelet count \>=100,000/mm3), liver function (total bilirubin \>=3 mg/dL and AST/ALT \>=150 IU/L), and renal function (creatinine clearance \>=60 mL/min) 6.No other serious comorbid disease 7.Adequate oral intake 8.Provided written informed consent

You may not qualify if:

• \. Patients with interstitial pneumonia or pulmonary fibrosis 2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. Patients with severe active infection 4. Patients who are pregnant or lactating, or have an intention to get pregnant 5. Patients with a history of severe drug allergy 6. Patients with other serious comorbid disease 7. Patients with mental disease 8. Patients who are judged inappropriate for the entry into the study by the principle doctor 9. Patients with watery diarrhea

Sponsors & Collaborators

• Kansai Hepatobiliary Oncology Group: lead

Study Sites (1)

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Related Publications (1)

• Kanai M, Hatano E, Kobayashi S, Fujiwara Y, Marubashi S, Miyamoto A, Shiomi H, Kubo S, Ikuta S, Yanagimoto H, Terajima H, Ikoma H, Sakai D, Kodama Y, Seo S, Morita S, Ajiki T, Nagano H, Ioka T. A multi-institution phase II study of gemcitabine/cisplatin/S-1 (GCS) combination chemotherapy for patients with advanced biliary tract cancer (KHBO 1002). Cancer Chemother Pharmacol. 2015 Feb;75(2):293-300. doi: 10.1007/s00280-014-2648-9. Epub 2014 Dec 5.

  PMID: 25477010 DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

S 1 (combination); Gemcitabine; Cisplatin

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Etsuro Hatano, MD, PhD

  Kyoto University Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 27, 2011
• Study Start: December 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2013
• Last Updated: July 1, 2014

Record last verified: 2014-06

Locations

JP (1)