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Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy

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ClinicalTrials.gov Identifier: NCT01682031
Recruitment Status : Terminated (Due to a lack of funding)
First Posted : September 10, 2012
Results First Posted : August 22, 2014
Last Update Posted : August 22, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Supportive Care
Conditions Chemotherapeutic Agent Toxicity
Mucositis
Radiation Toxicity
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Nasopharynx
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Larynx
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Oropharynx
Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Xerostomia
Interventions Dietary Supplement: selenomethionine
Other: placebo
Drug: cisplatin
Radiation: radiation therapy
Procedure: quality-of-life assessment
Enrollment 18

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Hide Arm/Group Description

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Period Title: Overall Study
Started 8 10
Completed 7 5
Not Completed 1 5
Reason Not Completed
Withdrawal by Subject             0             1
Adverse Event             0             2
MRI results indicate increased nodul             0             1
Patient could not swallow tablets             1             0
Patient stopped selenium on his own             0             1
Arm/Group Title Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy) Total
Hide Arm/Group Description

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Total of all reporting groups
Overall Number of Baseline Participants 8 10 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 10 participants 18 participants
56.6  (6.6) 57.4  (8.2) 57.1  (7.3)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  87.5%
9
  90.0%
16
  88.9%
>=65 years
1
  12.5%
1
  10.0%
2
  11.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 18 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
10
 100.0%
18
 100.0%
1.Primary Outcome
Title Incidence of >= Grade 3 Mucositis
Hide Description Will be compared as difference in proportions with 95% confidence intervals.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.
Arm/Group Title Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Hide Arm/Group Description:

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Tumor Complete Response Rate
Hide Description Will be compared as difference in proportions with 95% confidence intervals. Disease will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame Up to 5 years post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.
Arm/Group Title Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Hide Arm/Group Description:

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Relapse-free Survival (RFS)
Hide Description Assessed by Kaplan-Meier RFS curves and the proportion with an event at 1 year for RFS will be compared simultaneously to obtain more global sensitivity to differences in time-to-event.
Time Frame At 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.
Arm/Group Title Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Hide Arm/Group Description:

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Survival
Hide Description Estimated using the Kaplan-Meier method. Log-rank tests will be used for the comparison of survival distributions among study groups. Continuous endpoints will be summarized using means, standard deviations and percentiles.
Time Frame Up to 5 years post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.
Arm/Group Title Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Hide Arm/Group Description:

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Quality of Life
Hide Description [Not Specified]
Time Frame Up to 1 year post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Arm/Group Title Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Hide Arm/Group Description:

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia
Hide Description Will be compared as difference in proportions with 95% confidence intervals.
Time Frame Up to 5 years post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Hide Arm/Group Description:

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 8 10
Measure Type: Number
Unit of Measure: number of xerostomia events
1 0
7.Secondary Outcome
Title CRT Dose Delivery
Hide Description This characteristic will be included in Cox models.
Time Frame Up to 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.
Arm/Group Title Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Hide Arm/Group Description:

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)
Hide Description Descriptive statistics will be used to describe the mean plasma cisplatin and selenium at each time point. Repeated measures analysis of variance will be used to evaluate the changes in plasma cisplatin and selenium over time. Analysis of pharmacodynamic markers will be conducted using statistical methods appropriate for within-patient sequential analyses, such as repeated measures analysis of variance.
Time Frame Up to 3 months post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.
Arm/Group Title Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Hide Arm/Group Description:

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Hide Arm/Group Description

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

All-Cause Mortality
Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/8 (50.00%)      2/10 (20.00%)    
Blood and lymphatic system disorders     
Leukopenia   1/8 (12.50%)  3 0/10 (0.00%)  0
Cardiac disorders     
Ventricular tachycardia   1/8 (12.50%)  3 0/10 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain   1/8 (12.50%)  3 0/10 (0.00%)  0
Stomatitis   1/8 (12.50%)  3 0/10 (0.00%)  0
General disorders     
Mucosal inflammation   1/8 (12.50%)  3 1/10 (10.00%)  3
Pyrexia   1/8 (12.50%)  3 0/10 (0.00%)  0
Investigations     
Blood creatine increased   1/8 (12.50%)  3 0/10 (0.00%)  0
Blood sodium abnormal   1/8 (12.50%)  3 0/10 (0.00%)  0
Haemoglobin decreased   1/8 (12.50%)  3 0/10 (0.00%)  0
Neutrophil count decreased   1/8 (12.50%)  3 0/10 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration   1/8 (12.50%)  3 1/10 (10.00%)  3
Nervous system disorders     
Cerebrovascular accident   1/8 (12.50%)  3 0/10 (0.00%)  0
Dizziness   0/8 (0.00%)  0 1/10 (10.00%)  6
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain   1/8 (12.50%)  6 0/10 (0.00%)  0
Vascular disorders     
Orthostatic hypotension   0/8 (0.00%)  0 1/10 (10.00%)  3
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Placebo, Cisplatin, and Radiotherapy) Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      10/10 (100.00%)    
Blood and lymphatic system disorders     
Leukopenia   1/8 (12.50%)  3 2/10 (20.00%)  9
Lymphopenia   2/8 (25.00%)  18 3/10 (30.00%)  27
White blood cell disorder   1/8 (12.50%)  3 1/10 (10.00%)  3
Cardiac disorders     
Angina pectoris   1/8 (12.50%)  3 0/10 (0.00%)  0
Ear and labyrinth disorders     
Deafness   1/8 (12.50%)  3 1/10 (10.00%)  3
Ear pain   2/8 (25.00%)  6 0/10 (0.00%)  0
Hypoacusis   1/8 (12.50%)  3 0/10 (0.00%)  0
Otorrhoea   0/8 (0.00%)  0 1/10 (10.00%)  3
Tinnitus   1/8 (12.50%)  3 3/10 (30.00%)  12
Eye disorders     
Diplopia   0/8 (0.00%)  0 1/10 (10.00%)  3
Gastrointestinal disorders     
Abdominal discomfort   1/8 (12.50%)  3 0/10 (0.00%)  0
Constipation   5/8 (62.50%)  24 6/10 (60.00%)  30
Diarrhoea   1/8 (12.50%)  3 3/10 (30.00%)  21
Dry mouth   5/8 (62.50%)  15 5/10 (50.00%)  15
Dysphagia   5/8 (62.50%)  21 5/10 (50.00%)  15
Glossodynia   1/8 (12.50%)  3 0/10 (0.00%)  0
Lip disorder   0/8 (0.00%)  0 1/10 (10.00%)  3
Mouth ulceration   1/8 (12.50%)  3 1/10 (10.00%)  3
Nausea   5/8 (62.50%)  24 8/10 (80.00%)  27
Odynophagia   0/8 (0.00%)  0 2/10 (20.00%)  6
Oesophageal stenosis   1/8 (12.50%)  3 1/10 (10.00%)  3
Oral pain   1/8 (12.50%)  3 0/10 (0.00%)  0
Reflux gastritis   0/8 (0.00%)  0 1/10 (10.00%)  6
Salivary hypersecretion   2/8 (25.00%)  9 0/10 (0.00%)  0
Stomatitis   1/8 (12.50%)  3 2/10 (20.00%)  6
Vomiting   3/8 (37.50%)  9 2/10 (20.00%)  6
General disorders     
Asthenia   0/8 (0.00%)  0 1/10 (10.00%)  3
Fatigue   5/8 (62.50%)  21 6/10 (60.00%)  39
Fibrosis   1/8 (12.50%)  3 0/10 (0.00%)  0
Localised oedema   0/8 (0.00%)  0 2/10 (20.00%)  6
Mucosal inflammation   4/8 (50.00%)  24 6/10 (60.00%)  30
Oedema peripheral   1/8 (12.50%)  3 1/10 (10.00%)  3
Pain   1/8 (12.50%)  3 1/10 (10.00%)  3
Pyrexia   2/8 (25.00%)  6 2/10 (20.00%)  6
Secretion discharge   1/8 (12.50%)  3 0/10 (0.00%)  0
Infections and infestations     
Infection   0/8 (0.00%)  0 1/10 (10.00%)  3
Oral candidiasis   1/8 (12.50%)  3 1/10 (10.00%)  3
Perianal abscess   0/8 (0.00%)  0 1/10 (10.00%)  3
Injury, poisoning and procedural complications     
Radiation skin injury   4/8 (50.00%)  15 3/10 (30.00%)  9
Investigations     
Alanine aminotransferase increased   0/8 (0.00%)  0 1/10 (10.00%)  3
Aspartate aminotransferase increased   0/8 (0.00%)  0 1/10 (10.00%)  3
Blood bilirubin abnormal   0/8 (0.00%)  0 1/10 (10.00%)  6
Blood creatine increased   0/8 (0.00%)  0 1/10 (10.00%)  3
Blood creatinine increased   1/8 (12.50%)  6 0/10 (0.00%)  0
Blood sodium abnormal   1/8 (12.50%)  3 0/10 (0.00%)  0
Haemoglobin   1/8 (12.50%)  3 0/10 (0.00%)  0
Haemoglobin decreased   2/8 (25.00%)  9 4/10 (40.00%)  27
Neutrophil count decreased   2/8 (25.00%)  6 1/10 (10.00%)  3
Platelet count decreased   1/8 (12.50%)  3 2/10 (20.00%)  9
Weight decreased   2/8 (25.00%)  6 2/10 (20.00%)  9
White blood cell count decreased   0/8 (0.00%)  0 1/10 (10.00%)  3
Metabolism and nutrition disorders     
Anorexia   4/8 (50.00%)  18 3/10 (30.00%)  12
Decreased appetite   1/8 (12.50%)  3 0/10 (0.00%)  0
Dehydration   1/8 (12.50%)  3 3/10 (30.00%)  9
Hyperkalaemia   2/8 (25.00%)  15 0/10 (0.00%)  0
Hypermagnesaemia   1/8 (12.50%)  3 0/10 (0.00%)  0
Hypoalbuminaemia   2/8 (25.00%)  6 0/10 (0.00%)  0
Hypocalcaemia   1/8 (12.50%)  3 1/10 (10.00%)  3
Hypokalaemia   2/8 (25.00%)  6 1/10 (10.00%)  6
Hypomagnesaemia   1/8 (12.50%)  21 0/10 (0.00%)  0
Hyponatraemia   1/8 (12.50%)  6 4/10 (40.00%)  18
Oral intake reduced   0/8 (0.00%)  0 1/10 (10.00%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia   1/8 (12.50%)  3 0/10 (0.00%)  0
Muscle spasms   0/8 (0.00%)  0 1/10 (10.00%)  3
Musculoskeletal pain   0/8 (0.00%)  0 1/10 (10.00%)  3
Neck pain   1/8 (12.50%)  3 2/10 (20.00%)  6
Pain in extremity   0/8 (0.00%)  0 1/10 (10.00%)  3
Trismus   1/8 (12.50%)  3 0/10 (0.00%)  0
Nervous system disorders     
Ageusia   0/8 (0.00%)  0 1/10 (10.00%)  3
Dizziness   0/8 (0.00%)  0 2/10 (20.00%)  6
Dysarthria   0/8 (0.00%)  0 1/10 (10.00%)  3
Dysgeusia   4/8 (50.00%)  12 6/10 (60.00%)  21
Facial paresis   1/8 (12.50%)  3 0/10 (0.00%)  0
Headache   2/8 (25.00%)  12 1/10 (10.00%)  3
Peripheral sensory neuropathy   0/8 (0.00%)  0 1/10 (10.00%)  3
Psychiatric disorders     
Anxiety   1/8 (12.50%)  3 0/10 (0.00%)  0
Insomnia   1/8 (12.50%)  3 0/10 (0.00%)  0
Renal and urinary disorders     
Urinary retention   1/8 (12.50%)  6 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Aspiration   0/8 (0.00%)  0 2/10 (20.00%)  6
Cough   2/8 (25.00%)  6 2/10 (20.00%)  9
Dysphonia   2/8 (25.00%)  6 2/10 (20.00%)  6
Dyspnoea   0/8 (0.00%)  0 1/10 (10.00%)  3
Epistaxis   0/8 (0.00%)  0 1/10 (10.00%)  3
Hiccups   2/8 (25.00%)  6 1/10 (10.00%)  3
Increased upper airway secretion   0/8 (0.00%)  0 5/10 (50.00%)  18
Pharyngolaryngeal pain   4/8 (50.00%)  18 6/10 (60.00%)  24
Skin and subcutaneous tissue disorders     
Drug eruption   1/8 (12.50%)  3 0/10 (0.00%)  0
Dry skin   1/8 (12.50%)  3 2/10 (20.00%)  6
Erythema   4/8 (50.00%)  18 7/10 (70.00%)  30
Exfoliative rash   0/8 (0.00%)  0 1/10 (10.00%)  3
Rash   1/8 (12.50%)  3 1/10 (10.00%)  3
Rash generalised   1/8 (12.50%)  3 0/10 (0.00%)  0
Vascular disorders     
Hypertension   1/8 (12.50%)  3 0/10 (0.00%)  0
Orthostatic hypotension   2/8 (25.00%)  6 0/10 (0.00%)  0
Thrombosis   1/8 (12.50%)  3 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01682031     History of Changes
Obsolete Identifiers: NCT00935038
Other Study ID Numbers: I 107807
NCI-2009-01503 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: September 5, 2012
First Posted: September 10, 2012
Results First Submitted: June 26, 2014
Results First Posted: August 22, 2014
Last Update Posted: August 22, 2014