S-1 in Combination With Abraxane in Treating Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

Official title:

Phase II Study of Abraxane Plus S-1 as Second-line Treatment for Cholangiocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963325
• Other study ID #: S1vsNab-P20130819
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2013
• Last updated: February 1, 2018
• Start date: August 2013
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

Drug:
• S-1 plus Abraxane
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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yuhong Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rates		6 months
Secondary	Progression-free survival		6 months
Secondary	Number of participants with adverse events	Adverse events evaluated by Common Terminology Criteria for Adverse Events v3.0.	12 months