Chemotherapy and Radiation Therapy (RT) With or Without Vandetanib in Treating Patients With High-Risk Stage III or Stage IV Head and Neck Cancer

Stopped early · Phase 2

Conditions studied: Head and Neck Cancer

In brief

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without vandetanib in treating patients with head and neck cancer. PURPOSE: This randomized phase II trial is studying giving chemotherapy together with radiation therapy to see how well it works compared with giving chemotherapy and radiation therapy together with vandetanib in treating patients with high-risk stage III or stage IV head and neck cancer.

Key facts

Study ID

NCT00720083

Run by

Radiation Therapy Oncology Group

People needed

34

Starts

2008-11-01

Expected to finish

2011-08-01

Last updated by the study team

2015-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Zubrod performance status 0-1
• ANC (absolute neutrophil count) ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve this level allowed)
• Total bilirubin normal
• AST (aspartate aminotransferase) or ALT (alanine amino transferase) ≤ 2 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Serum creatinine ≤ 1.5 mg/dL
• Creatinine clearance ≥ 60 mL/min
• Glucose ≥ 40 mg/dL AND ≤ 250 mg/dL
• Sodium ≥ 130 mmol/L AND ≤ 155 mmol/L
• Magnesium ≥ 0.9 mg/dL AND ≤ 3 mg/dL (supplementation allowed)
• Potassium ≥ 4 mmol/L AND ≤ 6 mmol/L (supplementation allowed)
• Serum calcium (ionized or adjusted for albumin) ≥ 7 mg/dL AND ≤ 12.5 mg/dL (supplementation allowed)
• QTc (corrected QT interval) interval ≥ 480 msec must have 2 additional EKGs ≥ 24 hrs apart and the average QTc from the 3 screening EKGs must be < 480 msec
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 60 days after completion of study treatment
• May not donate blood during the study or for 3 months after last dose of vandetanib

You may not qualify if…

• Other simultaneous primary cancer
• Prior invasive malignancy (except nonmelanoma skin cancer) unless disease free for a minimum of 3 years with the exception of the following:
• Carcinoma in situ of the cervix
• Adequately treated basal cell or squamous cell carcinoma of the skin
• Untreated or treated low-risk prostate cancer (defined as clinical or pathologic T1c, N0 M0, PSA (prostate-specific antigen) < 10, Gleason < 7, < 50% of the total cores positive for cancer)
• Severe, active co-morbidity, defined as follows:
• Clinically significant cardiovascular event (e.g., myocardial infarction, superior vena cava syndrome, or New York Heart Association class II-IV) or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia within the past 3 months
• Unstable angina and/or congestive heart failure requiring hospitalization within the past 3 months
• Transmural myocardial infarction within the past 3 months
• History of arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE [Common Terminology Criteria for Adverse Events] grade 3), or asymptomatic sustained ventricular tachycardia
• Patients with atrial fibrillation, controlled on medication, are eligible
• Presence of left bundle branch block
• Previous history of QTc prolongation as a result from other medication that required discontinuation of that medication
• Congenital long QTc syndrome or first degree relative with unexplained sudden death under 40 years of age
• QTc with Bazett's correction that is unmeasurable or ≥ 480 msec on screening EKG
• Patients who are receiving a drug that has a risk of QTc prolongation are not eligible if QTc is ≥ 460 msec
• Hypertension (systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 100 mm Hg) not controlled by medical therapy
• Diarrhea ≥ grade 1 (increase of < 4 stools per day over baseline or mild increase in ostomy output compared to baseline)
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC (Center for Disease Control) definition (no HIV testing is required for study entry)
• Prior allergic reaction to cisplatin or vandetanib or derivatives similar to these drugs
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Rebecca and John Moores UCSD Cancer Center — La Jolla, California, United States
• USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States
• Radiological Associates of Sacramento Medical Group, Incorporated — Sacramento, California, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Winship Cancer Institute of Emory University — Altanta, Georgia, United States
• Ingalls Cancer Care Center at Ingalls Memorial Hospital — Harvey, Illinois, United States
• Cancer Institute at St. John's Hospital — Springfield, Illinois, United States
• Saint John's Cancer Center at Saint John's Medical Center — Anderson, Indiana, United States
• Methodist Cancer Center at Methodist Hospital — Indianapolis, Indiana, United States
• Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center — Kansas City, Kansas, United States
• James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky, United States
• Charach Cancer Center at Huron Valley - Sinai Hospital — Commerce, Michigan, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Josephine Ford Cancer Center at Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Regional Cancer Center at Singing River Hospital — Pascagoula, Mississippi, United States
• Truman Medical Center - Hospital Hill — Kansas City, Missouri, United States
• CCOP - Kansas City — Kansas City, Missouri, United States
• David C. Pratt Cancer Center at St. John's Mercy — St Louis, Missouri, United States
• Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center — Lincoln, Nebraska, United States
• Renown Institute for Cancer at Renown Regional Medical Center — Reno, Nevada, United States
• Memorial Sloan-Kettering Cancer Center - Basking Ridge — Basking Ridge, New Jersey, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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