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Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00798655
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : August 9, 2016
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Robert Ferris, University of Pittsburgh

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cancer of Head
Cancer of Head and Neck
Cancer of Neck
Cancer of the Head
Cancer of the Head and Neck
Cancer of the Neck
Head and Neck Cancer
Head Cancer
Head Neoplasms
Head, Neck Neoplasms
Neck Cancer
Neck Neoplasms
Neoplasms, Head
Neoplasms, Head and Neck
Neoplasms, Neck
Neoplasms, Upper Aerodigestive Tract
UADT Neoplasms
Upper Aerodigestive Tract Neoplasms
Interventions Drug: Panitumumab
Drug: Cisplatin
Radiation: Radiation Therapy
Enrollment 46
Recruitment Details  
Pre-assignment Details Study included patients with pathologic stage III or IVA squamous cell carcinoma of the oral cavity, larynx, hypopharynx, or human-papillomavirus (HPV) -negative oropharynx, without gross residual tumor, featuring high-risk factors (margins <1mm, extracapsular extension, perineural or angiolymphatic invasion, or ≥2 positive lymph nodes).
Arm/Group Title Radiation Therapy+Cisplatin+Panitumumab
Hide Arm/Group Description Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
Period Title: Overall Study
Started 46
Completed 44
Not Completed 2
Reason Not Completed
Did not receive at least one dose of pan             2
Arm/Group Title Radiation Therapy+Cisplatin+Panitumumab
Hide Arm/Group Description Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
58
(23 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
8
  18.2%
Male
36
  81.8%
1.Primary Outcome
Title Probability of Progression-free Survival (PFS) at 2 Years
Hide Description [Not Specified]
Time Frame Up to 90 months for cohort; individual patients up to 24 months after study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received 60-66 Gy over 6-7 weeks) concurrent with cisplatin 30 mg/m^2 and at least once dose of panitumumab 2.5 mg/kg.
Arm/Group Title Radiation Therapy+Cisplatin+Panitumumab
Hide Arm/Group Description:
Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70
(58 to 85)
2.Secondary Outcome
Title Probability of 2-year Overall Survival
Hide Description [Not Specified]
Time Frame Up to 90 months for cohort; individual patients up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received 60-66 Gy over 6-7 weeks) concurrent with cisplatin 30 mg/m^2 and at least once dose of panitumumab 2.5 mg/kg.
Arm/Group Title Radiation Therapy+Cisplatin+Panitumumab
Hide Arm/Group Description:
Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72
(60 to 87)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radiation Therapy+Cisplatin+Panitumumab
Hide Arm/Group Description Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
All-Cause Mortality
Radiation Therapy+Cisplatin+Panitumumab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Radiation Therapy+Cisplatin+Panitumumab
Affected / at Risk (%)
Total   18/46 (39.13%) 
Blood and lymphatic system disorders   
Hemoglobin   1/46 (2.17%) 
Lymphopenia   3/46 (6.52%) 
Cardiac disorders   
Hypotension   1/46 (2.17%) 
Gastrointestinal disorders   
Anorexia   1/46 (2.17%) 
Dehydration   1/46 (2.17%) 
Diarrhea   1/46 (2.17%) 
Dry mouth/salivary gland (xerostomia)   1/46 (2.17%) 
Dysphagia (difficulty swallowing)   1/46 (2.17%) 
Mucositis/stomatitis (clinical exam), Oral cavity   2/46 (4.35%) 
Nausea   1/46 (2.17%) 
Vomiting   1/46 (2.17%) 
General disorders   
Pain, Chest/thorax NOS   1/46 (2.17%) 
Pain, Pain NOS   1/46 (2.17%) 
Weight loss   1/46 (2.17%) 
Immune system disorders   
Allergic reaction/hypersensitivity   1/46 (2.17%) 
Infections and infestations   
Febrile neutropenia   1/46 (2.17%) 
Infection - Other (Specify, __)   1/46 (2.17%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Trachea   1/46 (2.17%) 
Nervous system disorders   
Dizziness   1/46 (2.17%) 
Psychosis (hallucinations/delusions)   1/46 (2.17%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Radiation Therapy+Cisplatin+Panitumumab
Affected / at Risk (%)
Total   46/46 (100.00%) 
Blood and lymphatic system disorders   
Platelets   3/46 (6.52%) 
Neutrophils/granulocytes (ANC/AGC)   3/46 (6.52%) 
Lymphopenia   3/46 (6.52%) 
Hemoglobin   3/46 (6.52%) 
Leukocytes (total WBC)   3/46 (6.52%) 
Lymphatics - Other (Specify, __)   9/46 (19.57%) 
Edema: head and neck   10/46 (21.74%) 
Cardiac disorders   
Hypotension   3/46 (6.52%) 
Hypertension   3/46 (6.52%) 
Ear and labyrinth disorders   
Auditory/Ear - Other (Specify, __)   3/46 (6.52%) 
Tinnitus   3/46 (6.52%) 
Endocrine disorders   
Thyroid function, low (hypothyroidism)   6/46 (13.04%) 
Gastrointestinal disorders   
Gastrointestinal - Other (Specify, __)   6/46 (13.04%) 
Dehydration   6/46 (13.04%) 
Diarrhea   6/46 (13.04%) 
Heartburn/dyspepsia   7/46 (15.22%) 
Salivary gland changes/saliva   7/46 (15.22%) 
Anorexia   7/46 (15.22%) 
Taste alteration (dysgeusia)   7/46 (15.22%) 
Vomiting   7/46 (15.22%) 
Dry mouth/salivary gland (xerostomia)   7/46 (15.22%) 
Mucositis/stomatitis (functional/symptomatic), Oral cavity   8/46 (17.39%) 
Constipation   8/46 (17.39%) 
Nausea   8/46 (17.39%) 
Dysphagia (difficulty swallowing)   8/46 (17.39%) 
Mucositis/stomatitis (clinical exam), Oral cavity   8/46 (17.39%) 
General disorders   
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)   3/46 (6.52%) 
Rigors/chills   3/46 (6.52%) 
Insomnia   4/46 (8.70%) 
Fatigue (asthenia, lethargy, malaise)   4/46 (8.70%) 
Weight loss   4/46 (8.70%) 
Pain, Esophagus   27/46 (58.70%) 
Pain, Pain NOS   27/46 (58.70%) 
Pain, Neck   29/46 (63.04%) 
Pain, Throat/pharynx/larynx   29/46 (63.04%) 
Pain, Oral cavity   30/46 (65.22%) 
Pain - Other (Specify, __)   30/46 (65.22%) 
Infections and infestations   
Infection - Other (Specify, __)   9/46 (19.57%) 
Metabolism and nutrition disorders   
Creatinine   10/46 (21.74%) 
Calcium, serum-high (hypercalcemia)   10/46 (21.74%) 
Glucose, serum-low (hypoglycemia)   10/46 (21.74%) 
Phosphate, serum-low (hypophosphatemia)   11/46 (23.91%) 
Bilirubin (hyperbilirubinemia)   11/46 (23.91%) 
Alkaline phosphatase   11/46 (23.91%) 
Magnesium, serum-high (hypermagnesemia)   12/46 (26.09%) 
Metabolic/Laboratory - Other (Specify, __)   13/46 (28.26%) 
ALT, SGPT (serum glutamic pyruvic transaminase)   14/46 (30.43%) 
Potassium, serum-high (hyperkalemia)   14/46 (30.43%) 
AST, SGOT(serum glutamic oxaloacetic transaminase)   15/46 (32.61%) 
Potassium, serum-low (hypokalemia)   15/46 (32.61%) 
Calcium, serum-low (hypocalcemia)   15/46 (32.61%) 
Magnesium, serum-low (hypomagnesemia)   15/46 (32.61%) 
Albumin, serum-low (hypoalbuminemia)   16/46 (34.78%) 
Glucose, serum-high (hyperglycemia)   18/46 (39.13%) 
Sodium, serum-low (hyponatremia)   19/46 (41.30%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal/Soft Tissue - Other (Specify, __)   22/46 (47.83%) 
Nervous system disorders   
Mood alteration, Depression   22/46 (47.83%) 
Dizziness   23/46 (50.00%) 
Neurology - Other (Specify, __)   24/46 (52.17%) 
Mood alteration, Anxiety   24/46 (52.17%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary/Upper Respiratory - Other (Specify, __)   31/46 (67.39%) 
Dyspnea (shortness of breath)   31/46 (67.39%) 
Cough   35/46 (76.09%) 
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)   35/46 (76.09%) 
Skin and subcutaneous tissue disorders   
Hair loss/alopecia (scalp or body)   4/46 (8.70%) 
Hyperpigmentation   4/46 (8.70%) 
Ulceration   4/46 (8.70%) 
Wound complication, non-infectious   4/46 (8.70%) 
Rash/desquamation   4/46 (8.70%) 
Pruritus/itching   4/46 (8.70%) 
Dermatology/Skin - Other (Specify, __)   5/46 (10.87%) 
Dry skin   5/46 (10.87%) 
Rash: dermatitis associated with radiation, Chemoradiation   5/46 (10.87%) 
Rash: dermatitis associated with radiation, Radiation   5/46 (10.87%) 
Rash: acne/acneiform   5/46 (10.87%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Ferris, MD
Organization: University of Pittsburgh
Phone: 412-647-4654
EMail: ferrrl@UPMC.EDU
Layout table for additonal information
Responsible Party: Robert Ferris, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00798655    
Other Study ID Numbers: 06-120
First Submitted: November 25, 2008
First Posted: November 26, 2008
Results First Submitted: June 28, 2016
Results First Posted: August 9, 2016
Last Update Posted: October 3, 2017