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

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China International Medical Foundation
• Collaborator: Chinese Society of Clinical Oncology
• Treatments: Endostar protein; Endostatins

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.