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Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Biliary Cancer

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Trial Information

Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 6 months

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

MJ Kang, MD, MSc

Investigator Role:

Study Director

Investigator Affiliation:

Asan Medical Center


Korea: Institutional Review Board

Study ID:




Start Date:

March 2008

Completion Date:

August 2011

Related Keywords:

  • Metastatic Biliary Cancer
  • biliary cancer
  • systemic chemotherapy
  • S-1
  • gemcitabine
  • cisplatin
  • Biliary Tract Neoplasms