Metastatic Biliary Cancer Clinical Trial
Official title:
Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer
| Verified date | December 2011 |
| Source | Asan Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 92 |
| Est. completion date | August 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Asan Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Asan Medical Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival rate at 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. | 6 months | No |
| Secondary | Response rate | Response to chemotherapy will be assessed using RECIST 1.0 criteria. | 6 months | No |
| Secondary | Toxicities | 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. | Up to 24 months | Yes |
| Secondary | overall survival | Overall survival is calculated from the date of enrollment to the date of death from any cause. | up to 36 months | No |