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

NCT00720083 | Terminated Phase 2 Results DMC

• 2 other identifiers: RTOG-0619CDR0000599867
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 63

Brief 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. 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.

Conditions

Head and Neck Cancer

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

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival

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

  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.

Study Arms (2)

RT + Cisplatin

ACTIVE COMPARATOR

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. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: cisplatin; Radiation: radiation therapy

RT + Cisplatin + Vandetanib

EXPERIMENTAL

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. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: cisplatin; Drug: vandetanib; Radiation: radiation therapy

Interventions

cisplatin DRUG

Given IV

RT + Cisplatin; RT + Cisplatin + Vandetanib

vandetanib DRUG

Given orally

RT + Cisplatin + Vandetanib

radiation therapy RADIATION

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

RT + Cisplatin; RT + Cisplatin + Vandetanib

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (63)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, 95815, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Winship Cancer Institute of Emory University

Altanta, Georgia, 30322, United States

Location

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Cancer Institute at St. John's Hospital

Springfield, Illinois, 62702, United States

Location

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

Anderson, Indiana, 46016, United States

Location

Methodist Cancer Center at Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

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

Kansas City, Kansas, 66160-7357, United States

Location

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40292, United States

Location

Charach Cancer Center at Huron Valley - Sinai Hospital

Commerce, Michigan, 48382, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Truman Medical Center - Hospital Hill

Kansas City, Missouri, 64108, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

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

St Louis, Missouri, 63141, United States

Location

Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, 68510, United States

Location

Renown Institute for Cancer at Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Memorial Sloan-Kettering Cancer Center - Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Radiation Oncology Associates, PA

Albuquerque, New Mexico, 87109, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Memorial Sloan-Kettering Cancer Center

Commack, New York, 11725, United States

Location

Highland Hospital of Rochester

Rochester, New York, 14620, United States

Location

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

Rochester, New York, 14642, United States

Location

Memorial Sloan-Kettering Cancer Center - Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Sleepy Hollow, New York, 10591, United States

Location

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, 27834, United States

Location

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Barberton Citizens Hospital

Barberton, Ohio, 44203, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Lake/University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

North Coast Cancer Care, Incorporated

Sandusky, Ohio, 44870, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, 17822-0001, United States

Location

Fox Chase Cancer Center Buckingham

Furlong, Pennsylvania, 18925, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

York Cancer Center at Apple Hill Medical Center

York, Pennsylvania, 17405, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Sentara Cancer Institute at Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Schiffler Cancer Center at Wheeling Hospital

Wheeling, West Virginia, 26003, United States

Location

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

Green Bay, Wisconsin, 54301-3526, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, 54601, United States

Location

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, 53295, United States

Location

Regional Cancer Center at Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States

Location

Waukesha Memorial Hospital Regional Cancer Center

Waukesha, Wisconsin, 53188, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; vandetanib; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Limitations and Caveats

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

Results Point of Contact

• Title: Wendy Seiferheld
• Organization: Radiation Therapy Oncology Group (RTOG)

wseiferheld@acr.com

Study Officials

• David Raben, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• John A. Ridge, MD, PhD

  Fox Chase Cancer Center

  STUDY CHAIR

• Stuart J. Wong, MD

  Medical College of Wisconsin

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2008
• First Posted: July 22, 2008
• Study Start: November 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 17, 2015
• Results First Posted: May 8, 2013

Record last verified: 2015-11

Locations

US (63)