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Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00939627
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : September 1, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Nasopharynx
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Salivary Gland Squamous Cell Carcinoma
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IVA Salivary Gland Cancer
Stage IVA Squamous Cell Carcinoma of the Larynx
Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVA Squamous Cell Carcinoma of the Oropharynx
Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IVA Verrucous Carcinoma of the Larynx
Stage IVA Verrucous Carcinoma of the Oral Cavity
Stage IVB Salivary Gland Cancer
Stage IVB Squamous Cell Carcinoma of the Larynx
Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVB Squamous Cell Carcinoma of the Oropharynx
Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IVB Verrucous Carcinoma of the Larynx
Stage IVB Verrucous Carcinoma of the Oral Cavity
Stage IVC Salivary Gland Cancer
Stage IVC Squamous Cell Carcinoma of the Larynx
Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVC Squamous Cell Carcinoma of the Oropharynx
Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IVC Verrucous Carcinoma of the Larynx
Stage IVC Verrucous Carcinoma of the Oral Cavity
Tongue Cancer
Untreated Metastatic Squamous Neck Cancer With Occult Primary
Interventions Biological: cetuximab
Other: placebo
Drug: sorafenib tosylate
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Enrollment 55
Recruitment Details Southeast Phase II Consortium (SEP2C) study enrolling participants at seven participating sites during August 2009 through October 2011.
Pre-assignment Details Fifty-five patients were consented and assigned to a treatment arm; 3 withdrew before treatment. Fifty-two patients were treated on study. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
Arm/Group Title Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate Participants Who Did Not Receive Treatment.
Hide Arm/Group Description Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.. Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21. Placebo Arm: The protocol was amended and this arm was removed.
Period Title: Overall Study
Started 27 28 0
Completed 0 0 0
Not Completed 27 28 0
Reason Not Completed
Disease Progression             16             12             0
Adverse Event             6             7             0
Death             0             2             0
Withdrawal by Subject             2             4             0
Other complicating disease             1             1             0
Not compliant             2             0             0
No off-tx reason given             0             2             0
Arm/Group Title Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate Total
Hide Arm/Group Description Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility. Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21. Total of all reporting groups
Overall Number of Baseline Participants 27 28 55
Hide Baseline Analysis Population Description
Baseline participant measures are based on total eligible, consented, patients. Three of 55 consenting patients did not receive treatment. One patient had disease progression before treatment and 2 patients withdrew before treatment, resulting in 52 patients on treatment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  74.1%
21
  75.0%
41
  74.5%
>=65 years
7
  25.9%
7
  25.0%
14
  25.5%
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants 28 participants 55 participants
59
(26 to 74)
60
(42 to 71)
59
(26 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
Female
2
   7.4%
5
  17.9%
7
  12.7%
Male
25
  92.6%
23
  82.1%
48
  87.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 28 participants 55 participants
27 28 55
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.
Time Frame On‐study date to lesser of date of progression or date of death from any cause (assessed up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off-study date or last known alive date.
Arm/Group Title Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate
Hide Arm/Group Description:
Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
Overall Number of Participants Analyzed 26 26
Median (95% Confidence Interval)
Unit of Measure: months
3
(1.9 to 5.0)
3.2
(1.8 to 4.2)
2.Secondary Outcome
Title Best Response
Hide Description

Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of longest diameter (LD) of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD.

Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.

Time Frame On-treatment date to date of disease progression (assessed up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with best overall response data. Patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.
Arm/Group Title Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate
Hide Arm/Group Description:
Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
Overall Number of Participants Analyzed 22 20
Measure Type: Number
Unit of Measure: participants
Patients with Complete Response 0 0
Patients with Partial Response 1 2
Patients with Stable Disease 11 10
Patients with Progressive Disease 9 8
Patients Not Evaluable 4 6
Patients with Less Than Partial Response 1 0
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)
Time Frame On-study date to date of death from any cause (assessed up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.
Arm/Group Title Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate
Hide Arm/Group Description:
Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
Overall Number of Participants Analyzed 26 26
Median (95% Confidence Interval)
Unit of Measure: months
9
(5.2 to 12.9)
5.7
(4.2 to 10.8)
4.Secondary Outcome
Title Number of Participants With Each Worst‐Grade Toxicity
Hide Description Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death
Time Frame On-study date to 30 days following final dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of patients reported with any toxicity. Because not all patients experience a toxicity, and some experience more than one; the number of patients analyzed does not coincide with the number of patients on study.
Arm/Group Title Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate
Hide Arm/Group Description:
Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
Overall Number of Participants Analyzed 23 24
Measure Type: Number
Unit of Measure: participants
Number of Patients with Worst-Grade Toxicity 1 6 7
Number of Patients with Worst-Grade Toxicity 2 11 4
Number of Patients with Worst-Grade Toxicity 3 5 12
Number of Patients with Worst-Grade Toxicity 4 1 1
Number of Patients with Worst-Grade Toxicity 5 0 0
5.Secondary Outcome
Title Gene Expression Levels
Hide Description Formalin-fixed, paraffin-embedded (FFPE) tumors were collected. The FFPE tumors were to be evaluated for p16 expression using immunohistochemistry staining with antibody. Gene Expression Levels (positive when >70% cells stained, otherwise negative) were to be described using frequencies.
Time Frame Pre-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Due to an insufficient amount of tumor tissue available to complete planned analysis, this analysis was abandoned.
Arm/Group Title Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate
Hide Arm/Group Description:
Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Overall Survival Associated With Immunomodulatory Cytokines
Hide Description Twelve immunomodulatory cytokines were selected based on previous a feasibility study and detected using multiplex Luminex bead assays from patient's plasma. One cytokines, HGF, was eliminated due to extremely low expression. Three representative cytokines, TGF-beta 1, IL-8 and VEGF were to be evaluated for association with survival due to clustering.
Time Frame Pre-therapy, up to about 42 months (follow-up for overall survival)
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected due to an insufficient amount of tumor tissue available.
Arm/Group Title Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate
Hide Arm/Group Description:
Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Quality of Life
Hide Description Quality of Life Survey results.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected as The Quality of Life survey instrument was not completed by study participants..
Arm/Group Title Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate
Hide Arm/Group Description:
Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 years, 4 months
Adverse Event Reporting Description All participants who received treatment.
 
Arm/Group Title Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate
Hide Arm/Group Description Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility. Patients received cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
All-Cause Mortality
Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/26 (19.23%)      10/27 (37.04%)    
Cardiac disorders     
Acute coronary syndrome  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Sinus tachycardia  1  0/26 (0.00%)  0 1/27 (3.70%)  2
Gastrointestinal disorders     
Dysphagia  1  2/26 (7.69%)  2 1/27 (3.70%)  1
General disorders     
Death NOS  1  1/26 (3.85%)  1 3/27 (11.11%)  3
Infusion related reaction  1  0/26 (0.00%)  0 1/27 (3.70%)  2
Immune system disorders     
Anaphylaxis  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Infections and infestations     
Esophageal infection  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Lung infection  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Investigations     
Blood bilirubin increased  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Metabolism and nutrition disorders     
Anorexia  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Dehydration  1  1/26 (3.85%)  1 2/27 (7.41%)  2
Hyperkalemia  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Hypercalcemia  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorder  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Neck pain  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps)  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Nervous system disorders     
Syncope  1  1/26 (3.85%)  2 0/27 (0.00%)  0
Psychiatric disorders     
Nervous system disorders - Other - related to pain meds  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Pneumonitis  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Respiratory failure  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Vascular disorders     
Hypertension  1  0/26 (0.00%)  0 1/27 (3.70%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A - Cetuximab Arm B - Cetuximab and Sorafenib Tosylate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/26 (96.15%)      27/27 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  1/26 (3.85%)  1 4/27 (14.81%)  8
Leukocytosis  1  2/26 (7.69%)  4 0/27 (0.00%)  0
Thrombotic thrombocytopenic purpura  1  1/26 (3.85%)  1 1/27 (3.70%)  1
Cardiac disorders     
Sinus tachycardia  1  0/26 (0.00%)  0 3/27 (11.11%)  4
Chest pain - cardiac  1  0/26 (0.00%)  0 1/27 (3.70%)  2
Ear and labyrinth disorders     
Tinnitus  1  2/26 (7.69%)  3 1/27 (3.70%)  1
Ear and labyrinth disorders - Other  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Ear pain  1  1/26 (3.85%)  1 0/27 (0.00%)  0
External ear pain  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Eye disorders     
Eye disorders - Other  1  5/26 (19.23%)  5 0/27 (0.00%)  0
Dry eye  1  2/26 (7.69%)  2 1/27 (3.70%)  1
Extraocular muscle paresis  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Eye pain  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Watering eyes  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Blurred vision  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  10/26 (38.46%)  11 8/27 (29.63%)  8
Nausea  1  7/26 (26.92%)  11 7/27 (25.93%)  11
Diarrhea  1  1/26 (3.85%)  2 10/27 (37.04%)  14
Dysphagia  1  2/26 (7.69%)  3 5/27 (18.52%)  7
Mucositis oral  1  4/26 (15.38%)  5 4/27 (14.81%)  5
Dry mouth  1  1/26 (3.85%)  1 5/27 (18.52%)  6
Vomiting  1  2/26 (7.69%)  2 4/27 (14.81%)  4
Gastroesophageal reflux disease  1  0/26 (0.00%)  0 3/27 (11.11%)  3
Gastrointestinal disorders - other  1  1/26 (3.85%)  1 2/27 (7.41%)  6
Oral dysesthesia  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Gastrointestinal pain  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Bloating  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Esophagitis  1  1/26 (3.85%)  1 0/27 (0.00%)  0
General disorders     
Fatigue  1  19/26 (73.08%)  31 18/27 (66.67%)  27
Pain  1  4/26 (15.38%)  5 6/27 (22.22%)  7
Chills  1  2/26 (7.69%)  2 2/27 (7.41%)  2
Edema - limbs  1  2/26 (7.69%)  3 1/27 (3.70%)  1
Non-cardiac chest pain  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Facial pain  1  0/26 (0.00%)  0 1/27 (3.70%)  2
Hypothermia  1  1/26 (3.85%)  1 0/27 (0.00%)  0
General disorders and administration site conditions  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Infusion related reaction  1  2/26 (7.69%)  2 0/27 (0.00%)  0
Fever  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Immune system disorders     
Cytokine release syndrome  1  1/26 (3.85%)  1 3/27 (11.11%)  3
Anaphylaxis  1  1/26 (3.85%)  1 2/27 (7.41%)  2
Immune system disorders - Other  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Infections and infestations     
Skin infection  1  4/26 (15.38%)  4 0/27 (0.00%)  0
Infections and infestations - other  1  2/26 (7.69%)  2 1/27 (3.70%)  1
Esophageal infection  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Wound infection  1  1/26 (3.85%)  3 1/27 (3.70%)  1
Papulopustular rash  1  2/26 (7.69%)  2 0/27 (0.00%)  0
Paronychia  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Nail infection  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Injury, poisoning and procedural complications     
Bruising  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Investigations     
Weight loss  1  3/26 (11.54%)  4 6/27 (22.22%)  7
Alkaline phosphatase increased  1  3/26 (11.54%)  5 3/27 (11.11%)  3
Blood bilirubin increased  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Aspartate aminotransferase increased  1  1/26 (3.85%)  1 1/27 (3.70%)  1
Lymphocyte count decreased  1  1/26 (3.85%)  1 0/27 (0.00%)  0
White blood cell decreased  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Platelet count decreased  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Hemoglobin increased  1  1/26 (3.85%)  3 0/27 (0.00%)  0
INR increased  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Neutrophil count decreased  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Metabolism and nutrition disorders     
Anorexia  1  6/26 (23.08%)  7 8/27 (29.63%)  11
Hyponatremia  1  4/26 (15.38%)  5 3/27 (11.11%)  3
Hyperglycemia  1  5/26 (19.23%)  7 2/27 (7.41%)  2
Hypokalemia  1  2/26 (7.69%)  3 3/27 (11.11%)  3
Hypomagnesemia  1  2/26 (7.69%)  2 3/27 (11.11%)  5
Dehydration  1  1/26 (3.85%)  1 3/27 (11.11%)  3
Hypoalbuminemia  1  2/26 (7.69%)  8 2/27 (7.41%)  3
Hypocalcemia  1  3/26 (11.54%)  6 2/27 (7.41%)  2
Hypercalcemia  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Metabolism and nutrition disorders - Other  1  1/26 (3.85%)  2 0/27 (0.00%)  0
Hypophosphatemia  1  1/26 (3.85%)  1 1/27 (3.70%)  1
Hyperkalemia  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Hypernatremia  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Neck pain  1  9/26 (34.62%)  11 5/27 (18.52%)  5
Bone pain  1  3/26 (11.54%)  4 2/27 (7.41%)  3
Arthralgia  1  1/26 (3.85%)  1 2/27 (7.41%)  2
Myalgia  1  3/26 (11.54%)  4 0/27 (0.00%)  0
Trismus  1  1/26 (3.85%)  1 2/27 (7.41%)  2
Muscoloskeletal and connective tissue disorders - Other  1  1/26 (3.85%)  1 1/27 (3.70%)  1
Joint range of motion decreased  1  1/26 (3.85%)  2 0/27 (0.00%)  0
Back pain  1  0/26 (0.00%)  0 2/27 (7.41%)  2
Pain in extremity  1  1/26 (3.85%)  2 1/27 (3.70%)  2
Chest wall pain  1  1/26 (3.85%)  1 1/27 (3.70%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - other  1  3/26 (11.54%)  3 5/27 (18.52%)  5
Nervous system disorders     
Headache  1  6/26 (23.08%)  8 8/27 (29.63%)  11
Peripheral sensory neuropathy  1  5/26 (19.23%)  5 3/27 (11.11%)  3
Dizziness  1  3/26 (11.54%)  3 2/27 (7.41%)  2
Peripheral motor neuropathy  1  3/26 (11.54%)  3 1/27 (3.70%)  1
Nervous system disorders - Other  1  1/26 (3.85%)  1 1/27 (3.70%)  2
Dysgeusia  1  1/26 (3.85%)  1 1/27 (3.70%)  1
Extrapyramidal disorder  1  0/26 (0.00%)  0 1/27 (3.70%)  3
Syncope  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Dysphasia  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Psychiatric disorders     
Insomnia  1  2/26 (7.69%)  2 3/27 (11.11%)  3
Confusion  1  0/26 (0.00%)  0 2/27 (7.41%)  2
Depression  1  2/26 (7.69%)  2 0/27 (0.00%)  0
Psychiatric disorders - Other  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Anxiety  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Restlessness  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Renal and urinary disorders     
Hematuria  1  0/26 (0.00%)  0 1/27 (3.70%)  4
Urinary frequency  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Urinary urgency  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  6/26 (23.08%)  7 11/27 (40.74%)  12
Dyspnea  1  7/26 (26.92%)  8 8/27 (29.63%)  10
Hoarseness  1  0/26 (0.00%)  0 3/27 (11.11%)  3
Bronchopulmonary hemorrhage  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Lung infection  1  0/26 (0.00%)  0 2/27 (7.41%)  3
Pharyngolaryngeal pain  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Voice alteration  1  1/26 (3.85%)  1 1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders - Other  1  3/26 (11.54%)  3 0/27 (0.00%)  0
Allergic rhinitis  1  0/26 (0.00%)  0 1/27 (3.70%)  2
Wheezing  1  2/26 (7.69%)  2 0/27 (0.00%)  0
Pharyngeal fistula  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Nasal congestion  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Aspiration  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Productive cough  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Pharyngeal mucositis  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Epistaxis  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Pneumonitis  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Bronchospasm  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  12/26 (46.15%)  21 10/27 (37.04%)  18
Rash acneiform  1  9/26 (34.62%)  12 9/27 (33.33%)  12
Alopecia  1  4/26 (15.38%)  4 3/27 (11.11%)  3
Dry skin  1  2/26 (7.69%)  3 3/27 (11.11%)  3
Skin and subcutaneous tissue disorders - other  1  3/26 (11.54%)  3 2/27 (7.41%)  3
Palmar-plantar erythrodysesthesia syndrome  1  2/26 (7.69%)  4 1/27 (3.70%)  1
Pruritus  1  1/26 (3.85%)  1 3/27 (11.11%)  3
Nail discoloration  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Nail ridging  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Skin ulceration  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Scalp pain  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Vascular disorders     
Hypotension  1  2/26 (7.69%)  4 2/27 (7.41%)  3
Hypertension  1  1/26 (3.85%)  1 2/27 (7.41%)  2
Thromboembolic event  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Lymphedema  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Hematoma  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Accrual ended early based on planned interim analysis, but the study was completed with existing participants.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jill Gilbert, M.D.
Organization: Vanderbilt Ingram Cancer Center
Phone: 615-343-4677
EMail: jill.gilbert@vanderbilt.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00939627    
Other Study ID Numbers: NCI-2012-02847
NCI-2012-02847 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MCC-15780 ( Other Identifier: H. Lee Moffitt Cancer Center and Research Institute )
8070 ( Other Identifier: CTEP )
P30CA076292 ( U.S. NIH Grant/Contract )
N01CM00100 ( U.S. NIH Grant/Contract )
First Submitted: July 14, 2009
First Posted: July 15, 2009
Results First Submitted: July 28, 2014
Results First Posted: September 1, 2015
Last Update Posted: January 23, 2018