search
Back to results

A Trial of Endostar in Patients With Carcinoma of the Head and Neck

Primary Purpose

Nasopharyngeal Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Endostar
Sponsored by
China International Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Neoplasms focused on measuring endostar, cisplatin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed unrespectable or postoperative recurrent squamous cell carcinoma of the head and neck;
  • No prior radiation or chemotherapy and biotherapy before;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Life expectancy greater than 3 months;

  • Patients must have adequate bone marrow function:

    • Platelets ≥ 80×109/L
    • Hemoglobin ≥100 g/L
    • Absolute NeutrophilCount ≥1.5×109/L
    • white blood cell≥ 3.5×109/L

  • Patients must have adequate liver and renal function:

    • Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2.5 × upper limit of normal
    • Alkaline phosphatase < 2.5 × upper limit of normal
    • Total bilirubin < 1.5 mg/dL
    • Creatinine <1.5 mg/dL× upper limit of normal
  • A cardiac ejection fraction > 50%;
  • Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

  • Participation in any investigational drug study within 4 weeks preceding the start of study treatment;
  • Age ≤18 or ≥75 years of Age;
  • Pregnant or breastfeeding women;
  • Serious, uncontrolled, concurrent infection(s) requiring antibiotics;
  • Clinically apparent central nervous system metastases or carcinomatous meningitis;
  • Treatment for other carcinomas within the last 3 months;
  • Patient unable or not willing to perform all study related biopsies and blood draws for exploratory endpoints will not be enrolled on study as all study related procedures are mandatory;
  • Patients with clinically significant cardiac disease (New York Heart Association Classification III or IV and cardiac arrhythmias not well controlled with medication), or myocardial infarction within the previous six months.

Sites / Locations

  • the Second Xiangya Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

SCCHN

SCCHN-Endostar

Arm Description

patients with advanced squamous cell carcinoma of the head and neck.IMRT.

patients with advanced squamous cell carcinoma of the head and neck.Endostar will be continuously intravenous pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week(d-5-d-1, d3-d7, d10-d14, d17-d21)during IMRT.

Outcomes

Primary Outcome Measures

Progression-Free Survival (Mon); PFS, According to RECIST v1.1
Time of tumor progression in patients with head and neck squamous cell carcinoma

Secondary Outcome Measures

Quality of life (QOL); Scores range from 0 to 5
Quality of life (QOL) in cancer patients

Full Information

First Posted
August 12, 2016
Last Updated
January 29, 2019
Sponsor
China International Medical Foundation
Collaborators
Chinese Society of Clinical Oncology
search

1. Study Identification

Unique Protocol Identification Number
NCT02902432
Brief Title
A Trial of Endostar in Patients With Carcinoma of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China International Medical Foundation
Collaborators
Chinese Society of Clinical Oncology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of recombinant human endostatin（continuously-pumped）combined with chemoradiotherapy in patients with advanced squamous cell carcinoma of the head and neck. The patients will be randomized to concurrent radiotherapy (CRT) arm and CRT + Endostar arm. All patients will receive one cycles of induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin and 3 cycles of chemotherapy after IMRT. Treatment cycles will be repeated every 21 days for a maximum of 4 cycles. In CRT + Endostar arm, Endostar will be continuously intravenous pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week (d-5-d-1, d3-d7, d10-d14, d17-d21) during IMRT.
Detailed Description
The patients will be randomized to CRT arm and CRT + Endostar arm. All patients will receive one cycles of induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin and 3 cycles of chemotherapy after IMRT. Treatment cycles will be repeated every 21 days for a maximum of 4 cycles. In CRT + Endostar arm, Endostar will be continuously intravenous pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week (d-5-d-1, d3-d7, d10-d14, d17-d21) during IMRT. Prior to enrollment in this study and while the patient is receiving the therapy, routine tests, ECG, head and neck CT scan and MRI will be performed to check the body's response to the treatment. Further more, before and after the treatment, the circulating endothelial cells (CECs), endothelial progenitor cells (CEPs), vascular endothelial growth factor (VEGF), Cancer embryo antigen (CEA), Neuron-specific enolase (NSE) in blood and Microvessel density (MVD), hypoxia-inducible factor-1a (HIF-1a), P53, VEGF, Survivin in pathological specimens will be tested. Patients with progressive disease or intolerable side effects will be removed from the study. Patients with stable disease or tumor response will continue therapy for a maximum of 4 cycles. Primary outcome: The response rate (RR), the clinical benefit rate (CBR), time of tumor progression (TTP). Secondary outcomes: The quality of life (QOL)，Safety and Tolerability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Neoplasms
Keywords
endostar, cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCCHN
Arm Type
Placebo Comparator
Arm Description
patients with advanced squamous cell carcinoma of the head and neck.IMRT.
Arm Title
SCCHN-Endostar
Arm Type
Experimental
Arm Description
patients with advanced squamous cell carcinoma of the head and neck.Endostar will be continuously intravenous pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week(d-5-d-1, d3-d7, d10-d14, d17-d21)during IMRT.
Intervention Type
Drug
Intervention Name(s)
Endostar
Other Intervention Name(s)
recombinant human endostatin
Intervention Description
The patients will be randomized to CRT arm and CRT+Endostar arm. All patients will receive one cycles of induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin and 3 cycles of chemotherapy after IMRT.
Primary Outcome Measure Information:
Title
Progression-Free Survival (Mon); PFS, According to RECIST v1.1
Description
Time of tumor progression in patients with head and neck squamous cell carcinoma
Time Frame
up to 40 months
Secondary Outcome Measure Information:
Title
Quality of life (QOL); Scores range from 0 to 5
Description
Quality of life (QOL) in cancer patients
Time Frame
up to 40 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed unrespectable or postoperative recurrent squamous cell carcinoma of the head and neck; No prior radiation or chemotherapy and biotherapy before; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Life expectancy greater than 3 months; Patients must have adequate bone marrow function: Platelets ≥ 80×109/L Hemoglobin ≥100 g/L Absolute NeutrophilCount ≥1.5×109/L white blood cell≥ 3.5×109/L Patients must have adequate liver and renal function: Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2.5 × upper limit of normal Alkaline phosphatase < 2.5 × upper limit of normal Total bilirubin < 1.5 mg/dL Creatinine <1.5 mg/dL× upper limit of normal A cardiac ejection fraction > 50%; Ability to understand and willingness to sign a written informed consent. Exclusion Criteria: Participation in any investigational drug study within 4 weeks preceding the start of study treatment; Age ≤18 or ≥75 years of Age; Pregnant or breastfeeding women; Serious, uncontrolled, concurrent infection(s) requiring antibiotics; Clinically apparent central nervous system metastases or carcinomatous meningitis; Treatment for other carcinomas within the last 3 months; Patient unable or not willing to perform all study related biopsies and blood draws for exploratory endpoints will not be enrolled on study as all study related procedures are mandatory; Patients with clinically significant cardiac disease (New York Heart Association Classification III or IV and cardiac arrhythmias not well controlled with medication), or myocardial infarction within the previous six months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ping liu, doctor
Organizational Affiliation
Second Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Second Xiangya Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Trial of Endostar in Patients With Carcinoma of the Head and Neck

We'll reach out to this number within 24 hrs