Second-Line Chemotherapy Combined With Endostatin for Recurrent/Metastatic HN Epithelial Tumors

NCT03989830 | Unknown Phase 2 DMC

• 1 other identifier: BJCH-2019YJZ24
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The prognoses of recurrent/metastatic head and neck epithelial tumors after first-line platinum-based chemotherapy is poor. The efficacy of second-line chemotherapy for those patients that cannot be re-irradiated or re-operated is limited according to NCCN guideline and other published data. This study was designed to evaluate the efficacy and safety of endostatin combined with second-line chemotherapy for patients of recurrent/metastatic head and neck epithelial tumors that cannot be re-irradiated or re-operated after fist-line platinum-based chemotherapy.

Conditions

Head and Neck Neoplasms

Keywords

Endostatins; Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  include complete remission, partial remission, and stable disease

  From the date of first drug administration, evaluation of response was performed every cycle during the treatment and then every 3 months after the completion of the treatment up to 36 months

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  From the date of first drug administration, evaluation of response was performed every cycle during the treatment and then every 3 months after the completion of the treatment up to 36 months

• Progress Free Survival (PFS)

  From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

• Overall Survival (OS)

  From the date of first drug administration until the date of death, assessed up to 36 months

Study Arms (1)

Second-line chemotherapy combined with Endostar

EXPERIMENTAL

Second-line chemotherapy+Endostar

Drug: second-line chemotherapy; Drug: Recombinant human endostatin

Interventions

second-line chemotherapy DRUG

choose appropriate regimen according to efficacy and adverse effects of first-line chemotherapy. q3W regimen, 6 cycles.

Also known as: chemotherapy

Second-line chemotherapy combined with Endostar

Recombinant human endostatin DRUG

7.5mg/m2/d，continuous intravenous pumping in 2ml/h for 5 days each cycle. Endostar(d-7) begins one week before chemotherapy(d0), first 5-day-pump(d-7 to d-2, 240ml, 2ml/h). Second 5-day-pump begins two days later (d1 to d5). the rest pumps can be done in the same manner. Three 5-day-pumps can be done during one chemotherapy cycle. Endostar will be pumped 18 weeks during 6 cycles'second-line chemotherapy.

Also known as: Endostar

Second-line chemotherapy combined with Endostar

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old，\<70 years old.
• KPS ≥70.
• Histopathology confirmed head and neck epithelial tumors, ie. Squamous cell carcinoma, adenocarcinoma, mucoepidermoid carcinoma, et al.
• Relapse or metastasize after fist-line platinum-based chemotherapy，and the lesions cannot be re-irradiated or re-operated.
• At least one measurable lesion (RECIST 1.1 version).
• Life expectancy ≥ 6 months.
• Adequate bone function: WBC≥3.0x109/L, ANC≥1.5 x109/L, HB≥90g/L, PLT≥100 x109/L. AST, ALT, Creatinine, urea nitrogen\<1.25 ULN, normal coagulation function parameters.

You may not qualify if:

• Malignant melanoma, lymphoma, other tumors from mesenchymal tissues.
• Second primary malignant tumors.
• Contraindications of chemotherapy: severe infections, significant cardiovascular disease, symptomatic arrythmia, uncontrolled diabetes mellitus, et al.
• HIV infection, untreated chronic hepatitis B infection or carriers of HBV DNA copies \>500IU/ml, active hepatitis C patients.
• Uncontrolled hypertension.
• Hemorrhagic tendency.
• Epileptic seizure.
• History of progression after anti-angiogenic target treatment.
• History of allergy to recombinant human endostatin.
• Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
• Receiving treatment of other clinical trials.

Sponsors & Collaborators

• Sun Yan: lead
• Peking University: collaborator
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (9)

• Lu S, Li L, Luo Y, Zhang L, Wu G, Chen Z, Huang C, Guo S, Zhang Y, Song X, Yu Y, Zhou C, Li W, Liao M, Li B, Xu L, Chen P, Hu C, Hu C. A multicenter, open-label, randomized phase II controlled study of rh-endostatin (Endostar) in combination with chemotherapy in previously untreated extensive-stage small-cell lung cancer. J Thorac Oncol. 2015 Jan;10(1):206-11. doi: 10.1097/JTO.0000000000000343.

  PMID: 25654728 BACKGROUND

• Cui C, Mao L, Chi Z, Si L, Sheng X, Kong Y, Li S, Lian B, Gu K, Tao M, Song X, Lin T, Ren X, Qin S, Guo J. A phase II, randomized, double-blind, placebo-controlled multicenter trial of Endostar in patients with metastatic melanoma. Mol Ther. 2013 Jul;21(7):1456-63. doi: 10.1038/mt.2013.79. Epub 2013 May 14.

  PMID: 23670576 BACKGROUND

• Zhou J, Wang L, Xu X, Tu Y, Qin S, Yin Y. Antitumor activity of Endostar combined with radiation against human nasopharyngeal carcinoma in mouse xenograft models. Oncol Lett. 2012 Nov;4(5):976-980. doi: 10.3892/ol.2012.856. Epub 2012 Aug 8.

  PMID: 23162635 BACKGROUND

• Wen QL, Meng MB, Yang B, Tu LL, Jia L, Zhou L, Xu Y, Lu Y. Endostar, a recombined humanized endostatin, enhances the radioresponse for human nasopharyngeal carcinoma and human lung adenocarcinoma xenografts in mice. Cancer Sci. 2009 Aug;100(8):1510-9. doi: 10.1111/j.1349-7006.2009.01193.x. Epub 2009 May 21.

  PMID: 19459845 BACKGROUND

• Guan Y, Li A, Xiao W, Liu S, Chen B, Lu T, Zhao C, Han F. The efficacy and safety of Endostar combined with chemoradiotherapy for patients with advanced, locally recurrent nasopharyngeal carcinoma. Oncotarget. 2015 Oct 20;6(32):33926-34. doi: 10.18632/oncotarget.5271.

  PMID: 26418895 BACKGROUND

• Jin T, Li B, Chen XZ. A phase II trial of Endostar combined with gemcitabine and cisplatin chemotherapy in patients with metastatic nasopharyngeal carcinoma (NCT01612286). Oncol Res. 2013;21(6):317-23. doi: 10.3727/096504014X13983417587401.

  PMID: 25198661 BACKGROUND

• Ye W, Liu R, Pan C, Jiang W, Zhang L, Guan Z, Wu J, Ying X, Li L, Li S, Tan W, Zeng M, Kang T, Liu Q, Thomas GR, Huang M, Deng W, Huang W. Multicenter randomized phase 2 clinical trial of a recombinant human endostatin adenovirus in patients with advanced head and neck carcinoma. Mol Ther. 2014 Jun;22(6):1221-1229. doi: 10.1038/mt.2014.53. Epub 2014 Mar 25.

  PMID: 24662947 BACKGROUND

• Hansma AH, Broxterman HJ, van der Horst I, Yuana Y, Boven E, Giaccone G, Pinedo HM, Hoekman K. Recombinant human endostatin administered as a 28-day continuous intravenous infusion, followed by daily subcutaneous injections: a phase I and pharmacokinetic study in patients with advanced cancer. Ann Oncol. 2005 Oct;16(10):1695-701. doi: 10.1093/annonc/mdi318. Epub 2005 Jul 12.

  PMID: 16012180 BACKGROUND

• Li X, Gu G, Soliman F, Sanders AJ, Wang X, Liu C. The Evaluation of Durative Transfusion of Endostar Combined with Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer. Chemotherapy. 2018;63(4):214-219. doi: 10.1159/000493098. Epub 2018 Oct 22.

  PMID: 30347389 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Drug Therapy; Endostatins; endostar protein

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• Sun Yan, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Yan, MD

CONTACT

0086-10-88196217; lisaysun@139.com

Xiao Shaowen, MD

CONTACT

0086-01-88196010; docxsw11@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Professor, Chief of Head and Heck Group of Radiotherapy Department, Peking University Cancer Hospital, Peking University

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: July 29, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2022
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)