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Completed

NCT Number: NCT01963325

S-1 in Combination With Abraxane in Treating Cholangiocarcinoma

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Paclitaxel Albumin-Bound Particles for Injectable Suspension, Gimeraciland Oteracil Porassium Capsules

Primary outcomes

  1. Response rates

    Time frame: 6 months

Secondary outcomes

  1. Progression-free survival

    Time frame: 6 months

  2. Number of participants with adverse events

    Time frame: 12 months

    Adverse events evaluated by Common Terminology Criteria for Adverse Events v3.0.

Sponsors and collaborators

Lead sponsor

Yuhong Li

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 16, 2013
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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