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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JLee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01375972
First received: June 15, 2011
Last updated: December 5, 2011
Last verified: December 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Asan Medical Center:

Primary Outcome Measures:
  • Progression-free survival rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Response to chemotherapy will be assessed using RECIST 1.0 criteria.

  • Toxicities [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Asan Medical Center

Additional 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
Study First Received: June 15, 2011
Last Updated: December 5, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by 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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014