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

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. Identifier: NCT01375972
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : December 6, 2011
Information provided by (Responsible Party):
JLee, Asan Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Biliary Cancer Drug: S-1 plus cisplatin Drug: Gemcitabine plus Cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
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
Study Start Date : March 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Response rate [ Time Frame: 6 months ]
    Response to chemotherapy will be assessed using RECIST 1.0 criteria.

  2. 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.

  3. 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.

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

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

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 identifier (NCT number): NCT01375972

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

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

Keywords provided by JLee, Asan Medical Center:
biliary cancer
systemic chemotherapy

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