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

Primary Purpose

Head and Neck Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

second-line chemotherapy

Recombinant human endostatin

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Endostatins, Head and Neck Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Second-line chemotherapy combined with Endostar

Arm Description

Second-line chemotherapy+Endostar

Outcomes

Primary Outcome Measures

Disease Control Rate (DCR)

include complete remission, partial remission, and stable disease

Secondary Outcome Measures

Objective Response Rate (ORR)

include complete remission and partial remission

Progress Free Survival (PFS)

1，2 years PFS

Overall Survival (OS)

1，2 years OS

Full Information

NCT ID

NCT03989830

First Posted

June 14, 2019

Last Updated

October 22, 2020

Sponsor

Sun Yan

Collaborators

Peking University, Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT03989830

Brief Title

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

Acronym

SLICER

Official Title

A Phase II Study of Second-line Chemotherapy Combined With Endostatin for Recurrent/Metastatic Head and Neck Epithelial Tumors That Cannot be Re-irradiated or Re-operated After Fist-line Platinum-based Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 29, 2019 (Actual)

Primary Completion Date

June 30, 2021 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sun Yan

Collaborators

Peking University, Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Detailed Description

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. New agent for second-line treatment of recurrent and/or metastatic head and neck tumors is urgently needed. Recombinant human endostatin is an anti-angiogenetic target drug, which has been demonstrated a good efficacy for NSCLC. Studies about recombinant human endostatin in head and neck cancer mainly focus on NPC. And phase I study of endostatin combined with chemotherapy and/or radiotherapy for NPC showed a promising results. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Neoplasms

Keywords

Endostatins, Head and Neck Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Second-line chemotherapy combined with Endostar

Arm Type

Experimental

Arm Description

Second-line chemotherapy+Endostar

Intervention Type

Drug

Intervention Name(s)

second-line chemotherapy

Other Intervention Name(s)

chemotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Recombinant human endostatin

Other Intervention Name(s)

Endostar

Intervention Description

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.

Primary Outcome Measure Information:

Title

Disease Control Rate (DCR)

Description

include complete remission, partial remission, and stable disease

Time Frame

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 Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

include complete remission and partial remission

Time Frame

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

Title

Progress Free Survival (PFS)

Description

1，2 years PFS

Time Frame

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

Title

Overall Survival (OS)

Description

1，2 years OS

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sun Yan, MD

Phone

0086-10-88196217

lisaysun@139.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiao Shaowen, MD

Phone

0086-01-88196010

docxsw11@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sun Yan, MD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yan Sun, MD

Phone

010-88196217

lisaysun@139.com

First Name & Middle Initial & Last Name & Degree

Shaowen Xiao, MD

Phone

010-88196010

docxsw11@163.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The data is administered by Peking University Cancer Hospital, the investigators need to request related department for sharing IPD.

Citations:

PubMed Identifier

25654728

Citation

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Results Reference

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PubMed Identifier

23670576

Citation

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PubMed Identifier

23162635

Citation

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.

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

25198661

Citation

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.

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PubMed Identifier

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Citation

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Citation

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

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