Back to resultsS-1 in Combination With Abraxane in Treating Cholangiocarcinoma
Primary Purpose
Cholangiocarcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S-1 plus Abraxane
Sponsored by
About this trial
This is an interventional treatment trial for Cholangiocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Histologic or cytologic diagnosis of cholangiocarcinoma
- Not eligible for curative surgery
- Progressed after first-line gemcitabine-based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better
- No serious or uncontrolled concomitant medical illness
- Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧90,000/ul), hemoglobin: > or equal to 8 mg/dL, total bilirubin: < or equal to 1.5 X institutional upper limit of normal, calculated creatinine clearance greater than or equal to 60 mL/min (calculated by the Cockcroft and Gault method).
Exclusion Criteria:
- Uncontrolled infection or severe active comorbid disease
- Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer
- Pregnancy or lactating women
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S-1 plus Abraxane
Arm Description
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment.
Outcomes
Primary Outcome Measures
Response rates
Secondary Outcome Measures
Progression-free survival
Number of participants with adverse events
Adverse events evaluated by Common Terminology Criteria for Adverse Events v3.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01963325
Brief Title
S-1 in Combination With Abraxane in Treating Cholangiocarcinoma
Official Title
Phase II Study of Abraxane Plus S-1 as Second-line Treatment for Cholangiocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuhong Li
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma.
Detailed Description
There are no standard second-line treatment for cholangiocarcinoma, new therapies are needed. The efficacy of S-1 as first-line treatment for cholangiocarcinoma was confirmed in several studies. The IMPACT study showed that Abraxane plus gemcitabine provide better survival than gemcitabine alone. Since cholangiocarcinoma displayed similar sensitivity to chemotherapy which was used in pancreatic carcinoma, we assume that S-1 plus Abraxane is effective and safe in treating cholangiocarcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-1 plus Abraxane
Arm Type
Experimental
Arm Description
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment.
Intervention Type
Drug
Intervention Name(s)
S-1 plus Abraxane
Other Intervention Name(s)
Paclitaxel Albumin-Bound Particles for Injectable Suspension, Gimeraciland Oteracil Porassium Capsules
Intervention Description
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment.
Primary Outcome Measure Information:
Title
Response rates
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
6 months
Title
Number of participants with adverse events
Description
Adverse events evaluated by Common Terminology Criteria for Adverse Events v3.0.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic or cytologic diagnosis of cholangiocarcinoma
Not eligible for curative surgery
Progressed after first-line gemcitabine-based chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better
No serious or uncontrolled concomitant medical illness
Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧90,000/ul), hemoglobin: > or equal to 8 mg/dL, total bilirubin: < or equal to 1.5 X institutional upper limit of normal, calculated creatinine clearance greater than or equal to 60 mL/min (calculated by the Cockcroft and Gault method).
Exclusion Criteria:
Uncontrolled infection or severe active comorbid disease
Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer
Pregnancy or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuhong Li, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
S-1 in Combination With Abraxane in Treating Cholangiocarcinoma
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