Nab-paclitaxel Combined with Bevacizumab in the Treatment of Metastatic Extrapulmonary Neuroendocrine Carcinoma

Last updated: March 11, 2025
Sponsor: Peking University
Overall Status: Completed

Phase

2

Condition

Neuroendocrine Carcinoma

Carcinoma

Treatment

Nab-paclitaxel Combined With Bevacizumab

Clinical Study ID

NCT04705519
CGOG3006/NEC-BEVAX
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who provided written informed consent to be subjects in this trial

  2. Aged ≥18 years

  3. Has histologically-confirmed diagnosis of locally advanced unresectable ormetastatic extrapulmonary neuroendocrine carcinoma

  4. Has received and progressed on ≥1 prior systemic therapy for their advanced disease.

  5. Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG)Performance Scale

  6. Have measurable disease as defined by RECIST 1.1 as determined by investigatorassessment

  7. Agree to provide tumor tissue sample deemed adequate for histopathology confirmation

  8. 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;

  9. Female subjects of childbearing potential must have a negative urine or serumpregnancy test within 7 days prior to receiving the first dose of study medicationand must be willing to use an adequate method of contraception for the course of thestudy through 90 days after the last dose of study medication. Male subjects ofchildbearing potential must agree to use an adequate method of contraceptionstarting with the first dose of study therapy through 90 days after the last dose ofstudy therapy

Exclusion

Exclusion Criteria:

  1. Patients have recovered adverse events associated with pretreatment to Grade 1 orlower with CTCAE v5.0 excluding alopecia

  2. Patients have an active malignancy (except for definitively treated basal cellcarcinoma of the skin, or carcinoma-in-situ of the cervix) within the past 5 years

  3. Patients with uncontrolled central nervous system metastasis

  4. Received anti-tumor therapy within 4 weeks, including: chemotherapy (the washoutperiod of oral fluorouracil drugs is 2 weeks), targeted therapy (the washout periodof small molecule targeted drugs is 2 weeks or 5 half-lives, whichever is shorter),immunotherapy, etc.;

  5. Received radical radiotherapy (including >25% bone marrow radiotherapy) and brainradiotherapy within 4 weeks; brachytherapy (such as implantation of radioactiveparticles) within 60 days; received palliative radiotherapy for bone metastaseswithin 1 week;

  6. Patients with a history of prior treatment with docetaxel, paclitaxel,nab-paclitaxel or bevacizumab

  7. Received surgery within 4 weeks or unhealed wounds, Ulcers, fractures;

  8. Uncontrollable malignant pleural effusion, ascites, or pericardial effusion (definedas the investigator's judgment cannot be effectively controlled by diuretics orpuncture);

  9. Patients have gastrointestinal diseases such as active gastric and duodenal ulcers,ulcerative colitis, or active bleeding from unresected tumors, or other conditionsjudged that may cause gastrointestinal bleeding or perforation;

  10. Patients with evidence or medical history of thrombosis or obvious bleeding tendencywithin 2 months (bleeding> 30 mL within 2 months, hematemesis, melena, blood in thestool), hemoptysis (> 5 mL of fresh blood within 4 weeks);

  11. Patients have arterial thrombosis or deep vein thrombosis occurred within 6 months;or stroke and/or transient ischemic attack occurred within 12 months;

  12. Active heart disease that is not well controlled, e.g. symptomatic coronary heartdisease, New York Heart Association (NYHA) congestive heart failure of grade II orabove, severe arrhythmias requiring drug intervention, myocardial infarction withinthe past 6 months, LVEF<50%

  13. Patients judged with clinically significant electrolyte abnormalities

  14. Patients have an active infection or an unexplained fever (temperature> 38.5℃)during the screening period or before the first administration

  15. Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatmentor have received anti-tuberculosis treatment within 1 year

  16. Is pregnant or breastfeeding

  17. Patients were judged unsuitable as subjects of this trial by investigators.

Study Design

Total Participants: 79
Treatment Group(s): 1
Primary Treatment: Nab-paclitaxel Combined With Bevacizumab
Phase: 2
Study Start date:
January 05, 2021
Estimated Completion Date:
September 30, 2024

Study 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).

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

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