Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab

This study has been withdrawn prior to enrollment.
(Funding source was terminated before enrollment of first subject)
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01312493
First received: March 8, 2011
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

This is a non-randomized phase II study of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous carcinoma of the head and neck.


Condition Intervention Phase
Head and Neck Cancer
Drug: Panitumumab
Radiation: Intensity Modulated Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Recurrence Rate of Locally Advanced Head & Neck Cancer [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Imaging for recurrence via CT scan will occur at 8 weeks (+/-5 days) post-RT, and will be repeated at 6, 9, 12, and 24 months from start of treatment.


Secondary Outcome Measures:
  • Patterns of Failure [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Evaluate locoregional recurrences to see if they arise in regions that were spared vs. treated, and assess long-term control after salvage therapy.

  • Time to Relapse [ Time Frame: first day of therapy to the first sign of progressive disease ] [ Designated as safety issue: No ]
    Imaging for recurrence via CT scan will occur at 8 weeks (+/-5 days) post-RT, and will be repeated at 6, 9, 12, and 24 months from start of treatment.

  • Morbidity of Treatment [ Time Frame: From screening until 30 days after treatment ] [ Designated as safety issue: Yes ]
    Toxicity will be assessed according to the NCI CTCAE v4.


Enrollment: 0
Study Start Date: December 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Panitumumab
    Weekly panitumumab intravenously at a dosage of 2.5 mg/kg started one week prior to RT until RT is completed. No more than 8 treatments.
    Other Name: Vectibix
    Radiation: Intensity Modulated Radiation Therapy
    The dose per fraction will be 2 Gy per day. Thus, the total number of fractions will be 35. Five days a week for 7 weeks.
    Other Name: IMRT
Detailed Description:

This is a non-randomized phase II trial of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous cell carcinoma of the head and neck. This protocol addresses patients with medical comorbidities that make them poor candidates for concurrent chemotherapy. Radiotherapy treatment will be directed at disease visible on diagnostic imaging modalities and the ipsilateral hemi-neck, sparing elective regions in the contralateral N0 hemi-neck with less than 20% chance of microscopic involvement. We explore the following hypothesis: Can acceptable locoregional disease control be obtained with less treatment-related morbidity by focusing RT on regions of gross disease, sparing regions with a low risk of harboring subclinical disease from elective RT?

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven primary squamous cell carcinoma arising in the oral cavity, oropharynx, hypopharynx, or larynx.
  • Stage III, IVA, or IVB disease (locally advanced with no systemic metastases and without bilateral nodal disease, i.e., N2c).
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2 with a life expectancy >12 months.
  • Patients are eligible if they have concurrent medical conditions that render them poor candidates for chemotherapy. Patients are considered to be in this group if any of the following criteria is met: Serum creatinine >1.5 mg/dl (or estimated creatinine clearance <50mL/min); Insulin dependent diabetes; SGOT, SGPT, or alkaline phosphatase >2.5 x upper limit of normal; History of significant CAD (myocardial infarction [MI], coronary artery bypass graft [CABG], coronary stents, symptomatic angina); Congestive heart failure [CHF] (LVEF <40% by echocardiogram or MUGA); nephropathy; Prior history of malignancy treated with chemotherapy; Severe chronic obstructive pulmonary disease [COPD], defined as FEV1 <1L; In the opinion of the treating physician, patient would not tolerate the administration of concurrent chemotherapy and radiation
  • Age >18 years.
  • The patient is medically fit to tolerate a course of definitive RT.
  • The patient has adequate hematologic function defined as: absolute neutrophil count >1000/ml, hematocrit >24%, and platelet count >50,000/ml. Patients with hematocrit between 20% and 24% should undergo transfusion, and may be enrolled provided their hematocrit reaches >24%.
  • The patient may have had a prior malignancy but must be disease-free for three years prior to study entry. A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix less than three years will be allowed.
  • The patient must agree to use effective contraception if childbearing potential exists and continue contraception for at least 6 months following completion of the study.
  • Evaluation by dental services prior to initiation of radiation therapy.
  • Patient must be informed of the investigational nature of the study and sign an informed consent form.

Exclusion Criteria:

  • The patient has received radiation therapy previously to the head and neck. NOTE: Previous radiotherapy for skin cancers of the head and neck are permitted if the fields do not overlap significantly.
  • All gross disease has been surgically resected. NOTE: Patients who have had an excisional neck biopsy will not be eligible.
  • Patient with positive contralateral neck node whether ipsilateral neck is negative or positive.
  • The patient is pregnant or lactating.
  • Squamous cell carcinoma arising in the nasopharynx, sinuses, salivary glands, or the primary is unknown.
  • Non-squamous histologies (such as adenoid cystic or mucoepidermoid carcinoma).
  • Spindle cell squamous carcinoma or mixed carcinoma/sarcoma.
  • Scleroderma or active connective tissue disorder (Lupus).
  • Any underlying psychological condition that would prohibit the understanding and rendering of informed consent.
  • Major surgery <3 weeks prior to study entry.
  • History of interstitial lung disease, e.g., pulmonary fibrosis or interstitial pneumonitis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312493

Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Amgen
Investigators
Principal Investigator: Neil Hayes, MD University of North Carolina, Chapel Hill
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01312493     History of Changes
Other Study ID Numbers: LCCC 1017
Study First Received: March 8, 2011
Last Updated: May 22, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Head and neck cancer
Phase II
Locally advanced
Panitumumab
Vectibix
Lineberger
Radiation Therapy
Intensity modulated radiation therapy (IMRT)
Stage III to IVB

Additional relevant MeSH terms:
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Neoplasms by Site
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014