S-1 in Combination With Abraxane in Treating Cholangiocarcinoma

NCT01963325 | Completed Phase 2 DMC

• 1 other identifier: S1vsNab-P20130819
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Response rates

  6 months

Secondary Outcomes (2)

• Progression-free survival

  6 months

• Number of participants with adverse events

  12 months

Study Arms (1)

S-1 plus Abraxane

EXPERIMENTAL

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.

Drug: S-1 plus Abraxane

Interventions

S-1 plus Abraxane DRUG

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.

Also known as: Paclitaxel Albumin-Bound Particles for Injectable Suspension, Gimeraciland Oteracil Porassium Capsules

S-1 plus Abraxane

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhong Li: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

S 1 (combination); Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Yuhong Li, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 16, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

CN (1)