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Head and Neck CancerPhase 2NCT00720083

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

A Phase 2 study testing cisplatin, vandetanib and radiation therapy in people with Head and Neck Cancer, run by Radiation Therapy Oncology Group at 63 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
cisplatin, vandetanib and radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
63 sitesUnited States
Study dates
Nov 2008to Aug 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 19Show fewer
  • 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

Who cannot join

  • 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:
Show all 32Show fewer
  • 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
  • No prior systemic chemotherapy for this disease (prior chemotherapy for a different cancer allowed)
  • No prior radiotherapy to the head and neck area that would result in overlap of radiotherapy fields
  • More than 30 days since prior investigational agents
  • More than 3 weeks since prior major surgery and recovered
  • More than 2 weeks since prior and no concurrent medications that induce Torsades de Pointes
  • More than 2 weeks since prior and no concurrent known potent inducers of CYP3A4 (Cytochrome P450 3A4), including rifampicin, phenytoin, carbamazepine, barbiturates, and Hypericum perforatum (St. John wort)
  • No concurrent medication that may cause QTc prolongation

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

United States63 sites

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Radiation Oncology Associates, PA

    Albuquerque, New Mexico, 87109

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • Winship Cancer Institute of Emory University

    Altanta, Georgia, 30322

  • Saint John's Cancer Center at Saint John's Medical Center

    Anderson, Indiana, 46016

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Memorial Sloan-Kettering Cancer Center - Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Memorial Sloan-Kettering Cancer Center

    Commack, New York, 11725

  • Charach Cancer Center at Huron Valley - Sinai Hospital

    Commerce, Michigan, 48382

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Fox Chase Cancer Center Buckingham

    Furlong, Pennsylvania, 18925

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27834

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46202

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40292

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Lake/University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Sentara Cancer Institute at Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Regional Cancer Center at Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Renown Institute for Cancer at Renown Regional Medical Center

    Reno, Nevada, 89502

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Memorial Sloan-Kettering Cancer Center - Rockville Centre

    Rockville Centre, New York, 11570

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

    Sleepy Hollow, New York, 10591

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

  • Schiffler Cancer Center at Wheeling Hospital

    Wheeling, West Virginia, 26003

  • York Cancer Center at Apple Hill Medical Center

    York, Pennsylvania, 17405

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of Chemoradiotherapy Versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head and Neck

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.

Read the detailed description

OBJECTIVES:

Primary

  • To screen for an indication that the addition of vandetanib to chemoradiotherapy may prolong disease-free survival as compared to a combination of chemoradiotherapy in patients with resected, high-risk stage III or IV head and neck squamous cell carcinoma.

Secondary

  • To determine whether this treatment regimen can be delivered safely and successfully following surgical resection for advanced head and neck cancer.
  • To estimate the locoregional progression, distant metastasis, and overall survival rates for patients treated with this regimen.
  • To examine the distribution of selected biomarkers that may include but are not limited to EGFR (epidermal growth factor receptor, total and phosphorylated), E-cadherin, pMAPK (phosphorylated mitogen-activated protein kinase), pAKT, Stat-3 (signal transducer and activator of transcription 3), Ki-67, COX-2 (cyclooxygenase 2), and cyclin B1 (G2/mitotic-specific cyclin-B1)expression in this group of patients and to explore the potential correlation between these markers with the ultimate treatment outcome

OUTLINE: This is a multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1) and primary site of disease (oral cavity/hypopharynx vs larynx vs oropharynx, HPV+ (human papillomavirus positive) vs oropharynx, HPV- (human papillomavirus negative)). Patients are randomized to 1 of 2 arms.

  • Arm I: Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
  • Arm II: Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy.

In both arms, treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.

Tissue samples from all patients are collected and reviewed. Tissue from patients with oropharyngeal carcinoma is analyzed for human papillomavirus.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 4 years, and then annually thereafter.

Being tested
cisplatin, vandetanib, radiation therapy
Keywords
stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatinDrug

    Given IV

  • vandetanibDrug

    Given orally

  • radiation therapyRadiation

    Patients undergo radiotherapy 5 times a week for up to 6.5 weeks.

Study groups in NCT00720083
Study groupRoleWhat they receive
RT + CisplatinActive comparatorPatients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cisplatin; Radiation: radiation therapy
RT + Cisplatin + VandetanibExperimentalPatients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cisplatin; Drug: vandetanib; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival

    This study terminated early with 34 subjects accrued out of 170 planned, therefore no analyses were performed.

    Measured: From randomization to date of failure (local, regional, or distant progression, or death) or last follow-up. Analysis occurs after 78 failures have been reported.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionAug 2011
  4. Study completionAug 2011

Why it stopped: Withdrawal of drug supply.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00720083
Sponsor's protocol ID
RTOG-0619
Other IDs
CDR0000599867
Status last verified
Nov 2015
First submitted
19 Jul 2008
Last updated
17 Nov 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, vandetanib and radiation therapy in people with Head and Neck Cancer, run by Radiation Therapy Oncology Group at 63 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (time frame: From randomization to date of failure (local, regional, or distant progression, or death) or last follow-up. Analysis occurs after 78 failures have been reported.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00720083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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