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

October 22, 2020 updated by: Sun Yan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥18 years old，<70 years old.
  2. KPS ≥70.
  3. Histopathology confirmed head and neck epithelial tumors, ie. Squamous cell carcinoma, adenocarcinoma, mucoepidermoid carcinoma, et al.
  4. Relapse or metastasize after fist-line platinum-based chemotherapy，and the lesions cannot be re-irradiated or re-operated.
  5. At least one measurable lesion (RECIST 1.1 version).
  6. Life expectancy ≥ 6 months.
  7. 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:

  1. Malignant melanoma, lymphoma, other tumors from mesenchymal tissues.
  2. Second primary malignant tumors.
  3. Contraindications of chemotherapy: severe infections, significant cardiovascular disease, symptomatic arrythmia, uncontrolled diabetes mellitus, et al.
  4. HIV infection, untreated chronic hepatitis B infection or carriers of HBV DNA copies >500IU/ml, active hepatitis C patients.
  5. Uncontrolled hypertension.
  6. Hemorrhagic tendency.
  7. Epileptic seizure.
  8. History of progression after anti-angiogenic target treatment.
  9. History of allergy to recombinant human endostatin.
  10. 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.
  11. Receiving treatment of other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Second-line chemotherapy combined with Endostar
Second-line chemotherapy+Endostar
Drug: second-line chemotherapy
choose appropriate regimen according to efficacy and adverse effects of first-line chemotherapy. q3W regimen, 6 cycles.
Other Names:
  • chemotherapy
Drug: Recombinant human endostatin
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.
Other Names:
  • Endostar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
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
include complete remission and partial remission
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)
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
1，2 years 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)
Time Frame: From the date of first drug administration until the date of death, assessed up to 36 months
1，2 years OS
From the date of first drug administration until the date of death, assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yan

Collaborators

Peking University
Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Sun Yan, MD, Peking University Cancer Hospital & Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 29, 2019

Primary Completion (ANTICIPATED)

June 30, 2021

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (ACTUAL)

June 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJCH-2019YJZ24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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