S-1 in Combination With Abraxane in Treating Cholangiocarcinoma

Yuhong Li

Status and phase: Completed; Phase 2

Conditions: Cholangiocarcinoma

Treatments: Drug: S-1 plus Abraxane

Study type: Interventional

Funder types: Other

Identifiers

NCT01963325

S1vsNab-P20130819

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

S-1 plus Abraxane

Experimental group

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.

Treatment:

Drug: S-1 plus Abraxane