We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01375972
First Posted: June 20, 2011
Last Update Posted: December 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JLee, Asan Medical Center
  Purpose
To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.

Condition Intervention Phase
Metastatic Biliary Cancer Drug: S-1 plus cisplatin Drug: Gemcitabine plus Cisplatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer

Resource links provided by NLM:


Further study details as provided by JLee, Asan Medical Center:

Primary Outcome Measures:
  • Progression-free survival rate at 6 months [ Time Frame: 6 months ]
    progression-free survival wad defined as the time from the date of enrollment to the date of the first occurrence of objective disease progression or death from any cause, which occur first.


Secondary Outcome Measures:
  • Response rate [ Time Frame: 6 months ]
    Response to chemotherapy will be assessed using RECIST 1.0 criteria.

  • Toxicities [ Time Frame: Up to 24 months ]
    Toxicities associated chemotherapy will be assessed and categorized using NCI CTCAE v3.0. The types of toxicities and the proportions of patients who experience each toxicity will be described.

  • overall survival [ Time Frame: up to 36 months ]
    Overall survival is calculated from the date of enrollment to the date of death from any cause.


Enrollment: 92
Study Start Date: March 2008
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SP treatment
S-1 plus cisplatin combination chemotherapy
Drug: S-1 plus cisplatin
S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks
Active Comparator: GP treatment
Gemcitabine plus Cisplatin combination chemotherapy
Drug: Gemcitabine plus Cisplatin
Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically proven biliary adenocarinoma
  2. Age > 18
  3. Evaluable disease
  4. ECOG performance status of 2 or better
  5. No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed
  6. Adequate bone marrow function A. WBCs > 4,000/µL, absolute neutrophil count [ANC]>1,500/µL B. Hemoglobin >9.0 g/dL C. Platelets > 100,000/µL
  7. Adequate kidney function (creatinine<1.5 mg/dL)
  8. Adequate liver function (bilirubin<1.5 mg/dL [< 2.5 mg/dL for obstructive jaundice with adequately decompressed bile duct obstruction], transaminases levels<3 times the upper normal limit, and serum albumin of >2.5 mg/dL)
  9. No serious medical or psychological condition that would preclude study treatment
  10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

  1. Other tumor type than adenocarcinoma
  2. Evidence of GI bleeding or GI obstruction
  3. Presence or history of CNS metastasis
  4. Pregnancy or breastfeeding
  5. Other serious illness or medical conditions
  6. Axial skeletal radiotherapy within 6 months
  7. Neuropathy grade 2 or worse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375972


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138736
Sponsors and Collaborators
Asan Medical Center
Investigators
Study Director: MJ Kang, MD, MSc Asan Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JLee, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01375972     History of Changes
Other Study ID Numbers: AMC_0803
First Submitted: June 15, 2011
First Posted: June 20, 2011
Last Update Posted: December 6, 2011
Last Verified: December 2011

Keywords provided by JLee, Asan Medical Center:
biliary cancer
systemic chemotherapy
S-1
gemcitabine
cisplatin

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs