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

Primary Purpose

Metastatic Biliary Cancer

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

S-1 plus cisplatin

Gemcitabine plus Cisplatin

About this trial

This is an interventional treatment trial for Metastatic Biliary Cancer focused on measuring biliary cancer, systemic chemotherapy, S-1, gemcitabine, cisplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically proven biliary adenocarinoma
Age > 18
Evaluable disease
ECOG performance status of 2 or better
No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed
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
Adequate kidney function (creatinine<1.5 mg/dL)
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)
No serious medical or psychological condition that would preclude study treatment
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

Other tumor type than adenocarcinoma
Evidence of GI bleeding or GI obstruction
Presence or history of CNS metastasis
Pregnancy or breastfeeding
Other serious illness or medical conditions
Axial skeletal radiotherapy within 6 months
Neuropathy grade 2 or worse

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SP treatment

GP treatment

Arm Description

S-1 plus cisplatin combination chemotherapy

Gemcitabine plus Cisplatin combination chemotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Response rate

Response to chemotherapy will be assessed using RECIST 1.0 criteria.

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.

overall survival

Overall survival is calculated from the date of enrollment to the date of death from any cause.

Full Information

NCT ID

NCT01375972

First Posted

June 15, 2011

Last Updated

December 5, 2011

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01375972

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Biliary Cancer

Keywords

biliary cancer, systemic chemotherapy, S-1, gemcitabine, cisplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SP treatment

Arm Type

Experimental

Arm Description

S-1 plus cisplatin combination chemotherapy

Arm Title

GP treatment

Arm Type

Active Comparator

Arm Description

Gemcitabine plus Cisplatin combination chemotherapy

Intervention Type

Drug

Intervention Name(s)

S-1 plus cisplatin

Intervention Description

S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks

Intervention Type

Drug

Intervention Name(s)

Gemcitabine plus Cisplatin

Intervention Description

Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks

Primary Outcome Measure Information:

Title

Progression-free survival rate at 6 months

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Response rate

Description

Response to chemotherapy will be assessed using RECIST 1.0 criteria.

Time Frame

6 months

Title

Toxicities

Description

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.

Time Frame

Up to 24 months

Title

overall survival

Description

Overall survival is calculated from the date of enrollment to the date of death from any cause.

Time Frame

up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically proven biliary adenocarinoma Age > 18 Evaluable disease ECOG performance status of 2 or better No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed 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 Adequate kidney function (creatinine<1.5 mg/dL) 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) No serious medical or psychological condition that would preclude study treatment Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Exclusion Criteria: Other tumor type than adenocarcinoma Evidence of GI bleeding or GI obstruction Presence or history of CNS metastasis Pregnancy or breastfeeding Other serious illness or medical conditions Axial skeletal radiotherapy within 6 months Neuropathy grade 2 or worse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MJ Kang, MD, MSc

Organizational Affiliation

Asan Medical Center

Official's Role

Study Director

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

138736

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

22559158

Citation

Kang MJ, Lee JL, Kim TW, Lee SS, Ahn S, Park DH, Lee SS, Seo DW, Lee SK, Kim MH. Randomized phase II trial of S-1 and cisplatin versus gemcitabine and cisplatin in patients with advanced biliary tract adenocarcinoma. Acta Oncol. 2012 Sep;51(7):860-6. doi: 10.3109/0284186X.2012.682628. Epub 2012 May 6.

Results Reference

derived

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

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