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

NCT01312493 | Withdrawn Phase 2 DMC

• 1 other identifier: LCCC 1017
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

Head and neck cancer; Phase II; Locally advanced; Panitumumab; Vectibix; Lineberger; Radiation Therapy; Intensity modulated radiation therapy (IMRT); Stage III to IVB

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate of Locally Advanced Head & Neck Cancer

  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.

  2 Years

Secondary Outcomes (3)

• Patterns of Failure

  2 Years

• Time to Relapse

  first day of therapy to the first sign of progressive disease

• Morbidity of Treatment

  From screening until 30 days after treatment

Interventions

Panitumumab DRUG

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.

Also known as: Vectibix

Intensity Modulated Radiation Therapy RADIATION

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.

Also known as: IMRT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Amgen: collaborator

Related Links

• UNC Lineberger Comprehensive Cancer Center Homepage
• National Cancer Institute Homepage

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Panitumumab; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Neil Hayes, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 10, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: August 28, 2015

Record last verified: 2015-08