A Prospective, Non-randomized, Multicenter, Phase II Study of Nab-paclitaxel Combined with Bevacizumab for Unresectable Recurrent or Metastatic Extrapulmonary Neuroendocrine Carcinoma

Peking University1 site in 1 country79 target enrollmentJanuary 5, 2021

ConditionsNeuroendocrine Carcinoma

InterventionsNab-paclitaxel Combined With Bevacizumab

DrugsNab-paclitaxel Combined With Bevacizumab

Overview

Phase: Phase 2
Intervention: Nab-paclitaxel Combined With Bevacizumab
Conditions: Neuroendocrine Carcinoma
Sponsor: Peking University
Enrollment: 79
Locations: 1
Primary Endpoint: Overall Survival (OS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, phase II study evaluating efficacy and safety of Nab-paclitaxel Combined With Bevacizumab for unresectable Recurrent or metastatic extrapulmonary neuroendocrine carcinoma.

Detailed Description

Nab-paclitaxel Combined With Bevacizumab will be evaluated in participants who have had ≥ 1 line of previous treatment. The primary endpoint is the Overall Survival (OS).

Registry

clinicaltrials.gov

Start Date

January 5, 2021

End Date

September 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking University

Responsible Party

Principal Investigator

Shen Lin

Professor

Peking University

Eligibility Criteria

Inclusion Criteria

•Patients who provided written informed consent to be subjects in this trial
•Aged ≥18 years
•Has histologically-confirmed diagnosis of locally advanced unresectable or metastatic extrapulmonary neuroendocrine carcinoma
•Has received and progressed on ≥1 prior systemic therapy for their advanced disease.
•Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
•Have measurable disease as defined by RECIST 1.1 as determined by investigator assessment
•Agree to provide tumor tissue sample deemed adequate for histopathology confirmation
•Adequate Organ Function Laboratory Values:
•Hemoglobin ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelets ≥80×109/L; AST and ALT ≤ 1.5 ULN or ≤ 3 ULN for subjects with liver metastases; Total bilirubin ≤1.5 ULN; Serum creatinine ≤1.5 ULN or measured or calculated creatinine clearance \> 50ml/min; Albumin ≥ 30g/L;
•Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication and must be willing to use an adequate method of contraception for the course of the study through 90 days after the last dose of study medication. Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy

Exclusion Criteria

•Patients have recovered adverse events associated with pretreatment to Grade 1 or lower with CTCAE v5.0 excluding alopecia
•Patients have an active malignancy (except for definitively treated basal cell carcinoma of the skin, or carcinoma-in-situ of the cervix) within the past 5 years
•Patients with uncontrolled central nervous system metastasis
•Received anti-tumor therapy within 4 weeks, including: chemotherapy (the washout period of oral fluorouracil drugs is 2 weeks), targeted therapy (the washout period of small molecule targeted drugs is 2 weeks or 5 half-lives, whichever is shorter), immunotherapy, etc.;
•Received radical radiotherapy (including \>25% bone marrow radiotherapy) and brain radiotherapy within 4 weeks; brachytherapy (such as implantation of radioactive particles) within 60 days; received palliative radiotherapy for bone metastases within 1 week;
•Patients with a history of prior treatment with docetaxel, paclitaxel, nab-paclitaxel or bevacizumab
•Received surgery within 4 weeks or unhealed wounds, Ulcers, fractures;
•Uncontrollable malignant pleural effusion, ascites, or pericardial effusion (defined as the investigator's judgment cannot be effectively controlled by diuretics or puncture);
•Patients have gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors, or other conditions judged that may cause gastrointestinal bleeding or perforation;
•Patients with evidence or medical history of thrombosis or obvious bleeding tendency within 2 months (bleeding\> 30 mL within 2 months, hematemesis, melena, blood in the stool), hemoptysis (\> 5 mL of fresh blood within 4 weeks);

Arms & Interventions

Nab-paclitaxel Combined With Bevacizumab

Nab-paclitaxel, Bevacizumab

Intervention: Nab-paclitaxel Combined With Bevacizumab

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: an expected average of 24 months

Duration from the date of initial treatment to the date of death due to any cause

Secondary Outcomes

Progression Free Survival (PFS)(an expected average of 24 months)
Duration of Response (DoR)(From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
Adverse events(an expected average of 24 months)
Overall Response Rate (ORR)(From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
Disease Control Rate (DCR)(From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)