Phase II Trial of Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment

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Brief Title

Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment

Official Title

Phase II Trial of Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment

Brief Summary

      To evaluate the following items in patients with advanced cholangiocarcinoma receiving
      lenvatinib plus paclitaxel treatment, Primary endpoint: Overall response rate (ORR) by RECIST
      1.1 Secondary endpoints Progression-free survival (PFS) Time to progression Overall survival
      Disease control rate (Overall response rate + stable disease ≧ 4 weeks) Response rate by
      modified RECIST Association between therapeutic efficacy and tumor vascularity Quality of
      life Safety profile Predictive biomarker of cholangiocarcinoma
    

Detailed Description

      1. Safety run-in phase: 3-6 cases Traditional 3+3 design is applied for the determination
           of initial lenvatinib dose.

        2. Extension phase:

           The estimated number of patients in current trial is calculated with Simon's minimax
           two-stage analysis. Considering the response rate is at least 10% higher (based on
           Ueno's data) than the 5% response rate of mFOLFOX in patients who fail gemcitabine plus
           cisplatin in ABC-06 trial, the assumption of response rate of lenvatinib plus paclitaxel
           will is 15% or higher. Therefore, Simon's minimax two-stage design is applied with P0 =
           5%, P1 = 15%, error 0.10, and errors 0.20. If tumor response is not observed in the
           first 29 patients, the study will be stopped. Otherwise, 15 additional patients be
           accrued for a total of 44. The null hypothesis will be rejected if 5 or more subjects
           have tumor response to the treatment of lenvatinib plus paclitaxel in 44 patients. If
           the investigators assume that drop-out rate is 10%, total accrual patient will be 49.

        3. Total case number = patients in safety run-in phase + patients in extension phase = (3 -
           6) + 49 = 52 - 55
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall response rate

Secondary Outcome

 Progression-free survival (PFS)

Condition

Advanced Biliary Tract Cancer

Intervention

Lenvatinib Pill,Paclitaxel

Study Arms / Comparison Groups

 Lenvatinib 12 or 16 mg/day orally,D28; Paclitaxel 80 mg/m2 in 250-500 mL of NS, IV D 1, 8, 15;
Description:  one arm Lenvatinib 16 or 12 mg/day orally day 1-28; Paclitaxel 80 mg/m2 in 250-500 mL of normal saline, intravenously over 2 hours on day 1, 8, 15;

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

55

Start Date

July 1, 2022

Completion Date

June 30, 2028

Primary Completion Date

June 30, 2026

Eligibility Criteria

        Inclusion Criteria:

          -  1. Patients with age ≧20 years old.

          -  2.Histologically confirmed biliary tract cancer which is locally advanced, recurrent
             or metastatic disease. The disease entities include intrahepatic cholangiocarcinoma,
             perihilar cholangiocarcinoma, distal bile duct cholangiocarcinoma, Ampulla of Vater
             cancer, and gallbladder cancer.

             3.Documented disease progression during or within 6 months after gemcitabine-based
             (regimens containing gemcitabine plus cisplatin, gemcitabine plus S-1, or gemcitabine
             plus oxaliplatin) chemotherapy. Patient who has received antiangiogenetic agent
             (bevacizumab, ramucirumab, lenvatinib), taxane-based chemotherapy, or more than 1 line
             of chemotherapy for locally advanced or metastatic biliary tract cancer is ineligible.

             4. Documented measurable disease as defined by RECIST v1.1. 5. Baseline Eastern
             Cooperative Oncology Group performance status score 0-1. 6. Patient has life
             expectancy of at least 12 weeks. 7. Adequate hematologic parameters, and hepatic and
             renal functions defined as 7.1: Hepatic: alanine aminotransferase (ALT) and aspartate
             aminotransferase (AST) 2.5 x upper limit of normal (ULN) ( 5.0 x ULN if attributable
             to liver metastases), total bilirubin 3 mg/dL.

        7.2: Renal: serum creatinine level 1.5 x ULN or creatinine clearance > 30 ml/min
        [calculated by either Cockcroft-Gault equation [(140-age) x body weight (kg) x (1 if male
        or 0.85 if female) / (72 x serum creatinine level, mg/dl)] or 24-hour urine test].

        7.3: Hematological: white blood cell 3,000/ul, absolute neutrophil count (ANC) 1,500/ul,
        hemoglobin 9 g/dl and platelet count 90,000/ul.

        8. Adequate controlled blood pressure (BP), defined as BP≦140/90 mmHg at screening and no
        change in antihypertensive medication within 1 week prior to the cycle1/day 1.

        9. Adequate blood coagulation function, defined as prothrombin time international
        normalized ratio (PT INR)≦ 2.3.

        10. Normal ECG or ECG without any clinical significant findings 11. Able to understand and
        sign an informed consent (or have a legal representative who is able to do so).

        12. Women or men of reproductive potential should agree to use an effective contraceptive
        method

        Exclusion Criteria:

          -  1. Patients who have major abdominal surgery, radiotherapy or other investigating
             agents within 2 weeks are not eligible. Patients who have palliative radiotherapy will
             be eligible if the irradiated area does not involve the only lesion of measurable /
             evaluable disease.

             2. Patients having liver dysfunction with Child-Pugh score ≧7. 3. Patients with
             gastrointestinal malabsorption or condition that might affect the absorption of
             lenvatinib in the opinion of the investigator.

             4. Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage.
             Patients with tumor invasion/infiltration of major blood vessels should be excluded
             because of the potential risk of severe hemorrhage associated with tumor
             shrinkage/necrosis following therapy.

             5. Uncontrolled blood pressure (systolic BP>140 mmHg or diastolic BP>90 mmHg) in spite
             of an optimized regimen of antihypertensive medication.

             6. Significant cardiovascular impairment: history of congestive heart failure greater
             than New York Heart Association (NYHA) Class II, unstable angina, myocardial
             infarction or stroke within 6 months, or cardiac arrhythmia requiring medical
             treatment.

             7. Patients having > 1+ proteinuria on urine dipstick testing will undergo 24 h urine
             collection for quantitative assessment of proteinuria. Subjects with urine protein≧ 1
             g/24 h will be ineligible.

             8. Patients with electrolyte abnormalities that have not been corrected. 9. Patients
             with metastatic lesion in central nervous system. 10. Patients with active infection.
             11. Subjects who have not recovered adequately from any toxicity from other anti-
             cancer treatment regimens and/or complications from major surgery prior to starting
             therapy.

             12. Patients who have peripheral neuropathy > grade I of any etiology 13. Patients who
             have serious concomitant systemic disorders incompatible with the study, i.e. poorly
             controlled diabetes mellitus, auto-immune disorders, or other condition that in the
             opinion of the investigator would preclude the subject's participation in the study.

             14. Patients who have other prior or concurrent malignancy except for adequately
             treated in situ carcinoma or basal cell carcinoma of skin, or any malignancy which
             remains disease-free for 3 or more years after curative treatment.

             15. Females who are breastfeeding or pregnant at screening or baseline. 16. Patients
             with psychiatric illness which would preclude study compliance.
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT05170438

Organization ID

T1222


Responsible Party

Sponsor

Study Sponsor

National Health Research Institutes, Taiwan

Collaborators

 National Cheng-Kung University Hospital

Study Sponsor

, , 


Verification Date

December 2021