Know Cancer

or
forgot password

A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Stage II Squamous Cell Carcinoma of the Nasopharynx, Stage III Lymphoepithelioma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage IV Lymphoepithelioma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx

Thank you

Trial Information

A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer


PRIMARY OBJECTIVES:

I. Determine the safety and tolerability of bevacizumab and chemoradiotherapy comprising
cisplatin and radiotherapy followed by adjuvant therapy comprising cisplatin, fluorouracil,
and bevacizumab in patients with stage IIB-IVB nasopharyngeal cancer.

SECONDARY OBJECTIVES:

I. Determine the 1- and 2-year rates of locoregional progression-free in patients treated
with this regimen.

II. Determine the 1- and 2-year rates of distant metastases-free in patients treated with
this regimen.

III. Determine the 1- and 2-year rates of progression-free and overall survival of patients
treated with this regimen.

OUTLINE: This is a multicenter study.

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and
cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in
the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients
also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy
once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over
96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over
30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.


Inclusion Criteria:



- Histologically confirmed cancer of the nasopharynx based on biopsy of a primary
lesion and/or lymph nodes

- Histologic WHO types I-IIb/III

- Stage IIB-IVB disease

- No T1-2, N1 disease in which node positivity is based on the presence of
retropharyngeal lymph nodes

- No distant metastases

- Zubrod performance status 0-1

- WBC ≥ 4,000/mm³

- Hemoglobin ≥ 9.0 g/dL

- Platelet count ≥ 100,000/mm³

- Absolute neutrophil count ≥ 1,500/mm³

- INR ≤ 1.5

- aPTT ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 1.5 times ULN

- ALT and AST ≤ 1.5 times ULN

- Bilirubin ≤ 1.5 times ULN

- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min

- Urine protein:creatinine (UPC) ratio < 1.0

- If UPC > 0.5, 24-hour urine protein must be < 1,000 mg

- Hearing loss primarily sensorineural in nature and requiring a hearing aid or
intervention that interferes in a clinically significant way with activities of daily
living allowed

- Conductive hearing loss from tumor-related otitis media is allowed

- No severe, active comorbidity, including any of the following:

- Ongoing bleeding diathesis, hemorrhagic disorder, or coagulopathy within the
past 6 months

- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
within the past 6 months

- Esophageal varices, nonhealing wound, nonhealing ulcer, or bone fracture within
the past 6 months

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within the past 30 days

- Unstable angina and/or congestive heart failure or peripheral vascular disease
requiring hospitalization within the past 12 months

- Major medical or psychiatric illness that, in the opinion of the study
investigator, would preclude study compliance

- Active, untreated infection and/or acute bacterial or fungal infection requiring
intravenous antibiotics

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- History of significant weight loss (> 15% from baseline)

- History of arterial thromboembolic events

- Acquired immune deficiency syndrome

- Transmural myocardial infarction

- Cerebrovascular accident

- Transient ischemic attack

- Any other cardiac condition that, in the opinion of the investigator, would
preclude study compliance

- No gross hemoptysis or hematemesis, defined as bright red blood of ≥ 1 teaspoon per
coughing episode, within the last 4 weeks (incidental blood mixed with phlegm
allowed)

- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
or carcinoma in situ of the breast, oral cavity, or cervix

- Nutritional and physical condition considered suitable for study treatment

- No significant traumatic injury within the past 4 weeks

- No history of allergic reaction to the study drugs

- No baseline blood pressure > 150/100 mm Hg

- No peripheral neuropathy ≥ grade 2

- Not pregnant or nursing

- Negative serum pregnancy test

- Fertile patients must use effective contraception during and for ≥ 6 months after
completion of study treatment

- At least 10 days since prior and no concurrent dipyridamole, ticlopidine, clopidogrel
bisulfate, cilostazol, warfarin, heparin, daily treatment with acetylsalicylic acid
(> 325 mg/day), or nonsteroidal anti-inflammatory medications known to inhibit
platelet function

- No prior head and neck surgery of the primary tumor or lymph nodes except for
incisional or excisional biopsies

- More than 15 days since prior biopsies

- More than 1 week since prior fine-needle aspirations or placement of percutaneous
gastrostomy tube

- More than 4 weeks since prior major surgical procedures

- No prior radiotherapy to the region of the study cancer that would result in overlap
of radiation therapy fields

- No prior bevacizumab or other vascular endothelial growth factor-targeting agents

- No prior systemic chemotherapy for the study cancer

- Prior chemotherapy for a different cancer allowed

- No concurrent hematologic growth factors (e.g. filgrastim [G-CSF], darbepoetin alfa,
epoetin alfa) during study chemoradiotherapy

- No concurrent prophylactic growth factors for neutropenia during study adjuvant
therapy

- No concurrent prophylactic amifostine or pilocarpine

- No other concurrent experimental therapeutic cancer treatments

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year.

Outcome Description:

Estimated using a binomial distribution along with their associated 95% confidence intervals. Graded using the CTCAE version 3.0.

Outcome Time Frame:

From start of treatment to one year.

Safety Issue:

Yes

Principal Investigator

Nancy Lee

Investigator Role:

Principal Investigator

Investigator Affiliation:

American College of Radiology Imaging Network

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00736

NCT ID:

NCT00408694

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Stage II Squamous Cell Carcinoma of the Nasopharynx
  • Stage III Lymphoepithelioma of the Nasopharynx
  • Stage III Squamous Cell Carcinoma of the Nasopharynx
  • Stage IV Lymphoepithelioma of the Nasopharynx
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Nasopharyngeal Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Stanford UniversityStanford, California  94305
Community Medical CenterToms River, New Jersey  08755
Beth Israel Medical CenterNew York, New York  10003
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Holland Community HospitalHolland, Michigan  49423
Munson Medical CenterTraverse City, Michigan  49684
City of Hope Medical CenterDuarte, California  91010
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Beebe Medical CenterLewes, Delaware  19958
Mecosta County Medical CenterBig Rapids, Michigan  49307
Highland General HospitalOakland, California  94602
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Metro Health HospitalGrand Rapids, Michigan  49506
Solano Radiation Oncology CenterVacaville, California  95687
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Larry G Strieff MD Medical CorporationOakland, California  94609
University of Pittsburgh Medical Center - Shadyside HospitalPittsburgh, Pennsylvania  15213-2582
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
UPMC Cancer Center at Jefferson Regional Medical CenterClairton, Pennsylvania  15025
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
Memorial Health University Medical CenterSavannah, Georgia  31404
M D Anderson Cancer CenterHouston, Texas  77030
Froedtert and the Medical College of WisconsinMilwaukee, Wisconsin  53226
Valley Medical Oncology Consultants-Castro ValleyCastro Valley, California  94546
Eden Hospital Medical CenterCastro Valley, California  94546
Valley Medical Oncology Consultants-FremontFremont, California  94538
Bay Area Breast Surgeons IncOakland, California  94609
Bay Area Tumor Institution CCOPOakland, California  94609
Tom K Lee IncOakland, California  94609
Valley Medical Oncology ConsultantsPleasanton, California  94588
Valley Care Health System - PleasantonPleasanton, California  94588
Doctors Medical Center- JC Robinson Regional Cancer CenterSan Pablo, California  94806
M D Anderson Cancer Center- OrlandoOrlando, Florida  32806
John H Stroger Jr Hospital of Cook CountyChicago, Illinois  60612-3785
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Saint Mary's Health CareGrand Rapids, Michigan  49503
Spectrum Health at Butterworth CampusGrand Rapids, Michigan  49503
Mercy Health Partners-Hackley CampusMuskegon, Michigan  49442
Saint John's HospitalSpringfield, Missouri  65804
Cox Medical CenterSpringfield, Missouri  65807
Cooper Hospital University Medical CenterCamden, New Jersey  08103
Saint Luke's Roosevelt Hospital Center - Saint Luke's DivisionNew York, New York  10025
Pocono Medical CenterEast Stroudsburg, Pennsylvania  18301
Wheeling HospitalWheeling, West Virginia  26003
Northeast Radiation Oncology CenterDunmore, Pennsylvania  18512
Radiological Associates of SacramentoSacramento, California  95816
UMDNJ - New Jersey Medical SchoolNewark, New Jersey  07103
Riverview HospitalWisconsin Rapids, Wisconsin  54494
Magee-Womens Hospital - University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Upper Delaware Valley Cancer CenterMilford, Pennsylvania  18337
UPMC Cancer Center at UPMC McKeesportMcKeesport, Pennsylvania  15132
Washington HospitalWashington, Pennsylvania  15301
Boca Raton Regional HospitalBoca Raton, Florida  33486
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Bronson Battle CreekBattle Creek, Michigan  49017
Auburn Radiation Oncology CenterAuburn, California  95603
Marshall Radiation Oncology CenterCameron Park, California  95682
Mercy San Juan Medical CenterCarmichael, California  95608
Roseville Radiation Oncology CenterRoseville, California  95661
Mercy General Hospital Radiation Oncology CenterSacramento, California  95819
Saint Louis Children's HospitalSaint Louis, Missouri  63110
UPMC - Heritage Valley Health System - The Medical Center - BeaverBeaver, Pennsylvania  15009
UPMC Cancer Center at Clarion HospitalClarion, Pennsylvania  16214
UPMC Cancer Centers - Arnold Palmer PavilionGreensburg, Pennsylvania  15601
University Pittsburgh Medical Cancer Center-JohnstownJohnstown, Pennsylvania  15901
University of Pittsburgh Medical Center -Moon TownshipMoon Township, Pennsylvania  15108
University of Pittsburgh Medical Cancer Center - Natrona HeightsNatrona Heights, Pennsylvania  15065
Jameson Health System North CampusNew Castle, Pennsylvania  16105
University of Pittsburgh Medical Center-Passavant HospitalPittsburgh, Pennsylvania  15237
University of Pittsburgh Medical Center-Presbyterian HospitalPittsburgh, Pennsylvania  15213
UPMC Cancer Center at Saint Clair HospitalPittsburgh, Pennsylvania  15243
Saint Margaret Memorial HospitalPittsburgh, Pennsylvania  15215
University of Pittsburgh Medical Center NorthwestSeneca, Pennsylvania  16346
UPMC Cancer Center - Robert E Eberly PavilionUniontown, Pennsylvania  15401