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

NCT02902432 | Unknown Phase 2

• 1 other identifier: ChinaIMF
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Neoplasms

Keywords

endostar; cisplatin

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (Mon); PFS, According to RECIST v1.1

  Time of tumor progression in patients with head and neck squamous cell carcinoma

  up to 40 months

Secondary Outcomes (1)

• Quality of life (QOL); Scores range from 0 to 5

  up to 40 months

Study Arms (2)

SCCHN

PLACEBO COMPARATOR

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

Drug: Endostar

SCCHN-Endostar

EXPERIMENTAL

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.

Drug: Endostar

Interventions

Endostar DRUG

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.

Also known as: recombinant human endostatin

SCCHN; SCCHN-Endostar

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China International Medical Foundation: lead
• Chinese Society of Clinical Oncology: collaborator

Study Sites (1)

the Second Xiangya Hospital

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

endostar protein; Endostatins

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

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

• ping liu, doctor

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor in oncology

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: September 15, 2016
• Study Start: June 1, 2016
• Primary Completion: December 20, 2017
• Study Completion: January 1, 2019
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

CN (1)