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Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy (MAESTRO HN)

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ClinicalTrials.gov Identifier: NCT01256385
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : February 6, 2017
Last Update Posted : March 27, 2017
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 Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Laryngeal Verrucous Carcinoma
Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary
Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma
Recurrent Oral Cavity Verrucous Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Recurrent Salivary Gland Carcinoma
Salivary Gland Squamous Cell Carcinoma
Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary
Stage IV Hypopharyngeal Squamous Cell Carcinoma
Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma
Stage IVA Laryngeal Squamous Cell Carcinoma
Stage IVA Laryngeal Verrucous Carcinoma
Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma
Stage IVA Major Salivary Gland Carcinoma
Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage IVA Oral Cavity Verrucous Carcinoma
Stage IVA Oropharyngeal Squamous Cell Carcinoma
Stage IVB Laryngeal Squamous Cell Carcinoma
Stage IVB Laryngeal Verrucous Carcinoma
Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma
Stage IVB Major Salivary Gland Carcinoma
Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage IVB Oral Cavity Verrucous Carcinoma
Stage IVB Oropharyngeal Squamous Cell Carcinoma
Stage IVC Laryngeal Squamous Cell Carcinoma
Stage IVC Laryngeal Verrucous Carcinoma
Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma
Stage IVC Major Salivary Gland Carcinoma
Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage IVC Oral Cavity Verrucous Carcinoma
Stage IVC Oropharyngeal Squamous Cell Carcinoma
Tongue Carcinoma
Interventions Biological: Cetuximab
Other: Laboratory Biomarker Analysis
Drug: Temsirolimus
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Hide Arm/Group Description Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
Period Title: Overall Study
Started 43 43
Crossover From Arm B to Arm A 0 15
Completed 40 40
Not Completed 3 3
Reason Not Completed
Physician Decision             1             1
Withdrawal by Subject             2             2
Arm/Group Title Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus) Total
Hide Arm/Group Description Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A. Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
Three patients from each treatment arm did not start treatment and are considered non-evaluable.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
63
(48 to 86)
63
(39 to 81)
63
(39 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
8
  20.0%
3
   7.5%
11
  13.8%
Male
32
  80.0%
37
  92.5%
69
  86.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression determined using RECIST criteria: >=20% increase in the sum of the longest diameters of target lesions from nadir, occurrence of new lesions, or progression of non-target lesions.
Time Frame From start of treatment to time of progression or death from any cause, assessed up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Hide Arm/Group Description:
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
Overall Number of Participants Analyzed 40 40
Median (95% Confidence Interval)
Unit of Measure: days
105
(70 to 136)
105
(77 to 147)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Cetuximab and Temsirolimus), Arm B (Temsirolimus)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Time from randomization until death from any cause
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Hide Arm/Group Description:
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
Overall Number of Participants Analyzed 40 40
Median (95% Confidence Interval)
Unit of Measure: days
177
(146 to 247)
176
(131 to 316)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Cetuximab and Temsirolimus), Arm B (Temsirolimus)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Overall Response Rates (OR)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Statistics reported are for Overall Response (OR) = CR + PR.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Hide Arm/Group Description:
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.5
(4.2 to 26.8)
2.5
(0.1 to 13.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Cetuximab and Temsirolimus), Arm B (Temsirolimus)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title PFS vs. Historical Control Cohort
Hide Description PFS at 4 months in Arm A and Arm B will each be compared with a 4-month historical control rate of 21.4%. The historical data appears in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568 and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343.
Time Frame From start of treatment to time of progression or death of any cause, assessed at 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note: Each arm is separately compared to an historical rate of 21.4%, based on a one-sided test at the 0.05 significant level. Since the 90% CIs each exclude 21.4%, the 4-month PFS rate in both arms exceeds the fixed historical control rate.
Arm/Group Title Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Hide Arm/Group Description:
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
41.3
(28.3 to 54.3)
36.4
(22.6 to 50.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Cetuximab and Temsirolimus)
Comments PFS at 4 months in Arm A was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm B (Temsirolimus)
Comments PFS at 4 months in Arm B was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments 1-sided.
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Grade 3 or Higher Hematological Toxicity
Hide Description Incidence of hematological toxicities at least possibly related to study drug, graded based on Common Terminology Criteria for Adverse Events version 4
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Hide Arm/Group Description:
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
17.5
(7.3 to 32.8)
25
(12.7 to 41.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Cetuximab and Temsirolimus), Arm B (Temsirolimus)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Responses After Crossover From Control Arm to the Combination Arm, Assessed According to RECIST
Hide Description Percentage of responses (if any) after crossover from the control arm to the combination arm will be evaluated qualitatively. This is includes complete and partial responses, and is different from Outcome Measure 8 below, which includes complete and partial responses as well as stable disease.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Hide Arm/Group Description:
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
Overall Number of Participants Analyzed 0 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 21.8)
7.Secondary Outcome
Title PFS of Myofibroblast (+) Cohort
Hide Description [Not Specified]
Time Frame From start of treatment to time of progression or death of any cause, assessed up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Myofibroblast status was not determined. Concerns about the validity/technical feasibility as well as availability of the assay led us to decide to not perform the assay. We do not intend to perform this assay anymore.
Arm/Group Title Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Hide Arm/Group Description:
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Percentage of Responses/Disease Stabilization for Patients Crossing Over to the Combination Therapy After Progressing on Arm B.
Hide Description Assessed according to RECIST. This is includes complete and partial responses as well as stable disease, and is different from Outcome Measure 6 above, which includes only complete and partial responses.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Hide Arm/Group Description:
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
Overall Number of Participants Analyzed 0 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.7
(7.8 to 55.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Hide Arm/Group Description Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
All-Cause Mortality
Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Affected / at Risk (%) Affected / at Risk (%)
Total   14/40 (35.00%)   19/40 (47.50%) 
Blood and lymphatic system disorders     
Anemia *  0/40 (0.00%)  2/40 (5.00%) 
Cardiac disorders     
Heart failure *  0/40 (0.00%)  1/40 (2.50%) 
Myocardial infarction *  1/40 (2.50%)  0/40 (0.00%) 
Ear and labyrinth disorders     
Vertigo *  0/40 (0.00%)  1/40 (2.50%) 
Gastrointestinal disorders     
Nausea *  0/40 (0.00%)  1/40 (2.50%) 
Vomiting *  0/40 (0.00%)  1/40 (2.50%) 
General disorders     
Death NOS *  1/40 (2.50%)  0/40 (0.00%) 
Edema face *  0/40 (0.00%)  2/40 (5.00%) 
Fatigue *  1/40 (2.50%)  0/40 (0.00%) 
Fever *  1/40 (2.50%)  1/40 (2.50%) 
General disorders and administration site conditions - Other *  0/40 (0.00%)  2/40 (5.00%) 
Multi-organ failure *  1/40 (2.50%)  0/40 (0.00%) 
Non-cardiac chest pain *  1/40 (2.50%)  1/40 (2.50%) 
Pain *  1/40 (2.50%)  1/40 (2.50%) 
Infections and infestations     
Anorectal infection *  0/40 (0.00%)  1/40 (2.50%) 
Infections and infestations - Other *  1/40 (2.50%)  0/40 (0.00%) 
Lung infection *  3/40 (7.50%)  1/40 (2.50%) 
Pleural infection *  0/40 (0.00%)  1/40 (2.50%) 
Scrotal infection *  1/40 (2.50%)  0/40 (0.00%) 
Sinusitis *  0/40 (0.00%)  1/40 (2.50%) 
Skin infection *  1/40 (2.50%)  2/40 (5.00%) 
Wound infection *  2/40 (5.00%)  0/40 (0.00%) 
Injury, poisoning and procedural complications     
Tracheal hemorrhage *  0/40 (0.00%)  1/40 (2.50%) 
Tracheostomy site bleeding *  0/40 (0.00%)  1/40 (2.50%) 
Investigations     
Lymphocyte count decreased *  1/40 (2.50%)  0/40 (0.00%) 
Metabolism and nutrition disorders     
Dehydration *  0/40 (0.00%)  1/40 (2.50%) 
Hyperglycemia *  1/40 (2.50%)  2/40 (5.00%) 
Hypernatremia *  1/40 (2.50%)  2/40 (5.00%) 
Hypocalcemia *  1/40 (2.50%)  0/40 (0.00%) 
Hyponatremia *  0/40 (0.00%)  1/40 (2.50%) 
Musculoskeletal and connective tissue disorders     
Back pain *  1/40 (2.50%)  0/40 (0.00%) 
Bone pain *  1/40 (2.50%)  0/40 (0.00%) 
Generalized muscle weakness *  1/40 (2.50%)  0/40 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other *  0/40 (0.00%)  2/40 (5.00%) 
Nervous system disorders     
Dizziness *  0/40 (0.00%)  1/40 (2.50%) 
Renal and urinary disorders     
Acute kidney injury *  1/40 (2.50%)  0/40 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration *  1/40 (2.50%)  0/40 (0.00%) 
Bronchopulmonary hemorrhage *  1/40 (2.50%)  0/40 (0.00%) 
Cough *  0/40 (0.00%)  3/40 (7.50%) 
Dyspnea *  1/40 (2.50%)  7/40 (17.50%) 
Hypoxia *  1/40 (2.50%)  1/40 (2.50%) 
Laryngeal edema *  1/40 (2.50%)  0/40 (0.00%) 
Laryngeal obstruction *  0/40 (0.00%)  1/40 (2.50%) 
Pharyngeal hemorrhage *  1/40 (2.50%)  1/40 (2.50%) 
Pleural effusion *  0/40 (0.00%)  2/40 (5.00%) 
Pleuritic pain *  0/40 (0.00%)  1/40 (2.50%) 
Pneumonitis *  1/40 (2.50%)  0/40 (0.00%) 
Pneumothorax *  1/40 (2.50%)  1/40 (2.50%) 
Respiratory failure *  0/40 (0.00%)  3/40 (7.50%) 
Respiratory, thoracic and mediastinal disorders - Other *  0/40 (0.00%)  1/40 (2.50%) 
Stridor *  0/40 (0.00%)  1/40 (2.50%) 
Skin and subcutaneous tissue disorders     
Rash acneiform *  1/40 (2.50%)  0/40 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A (Cetuximab and Temsirolimus) Arm B (Temsirolimus)
Affected / at Risk (%) Affected / at Risk (%)
Total   39/40 (97.50%)   37/40 (92.50%) 
Blood and lymphatic system disorders     
Anemia *  24/40 (60.00%)  26/40 (65.00%) 
Leukocytosis *  1/40 (2.50%)  2/40 (5.00%) 
Ear and labyrinth disorders     
Ear pain *  1/40 (2.50%)  2/40 (5.00%) 
Hearing impaired *  0/40 (0.00%)  2/40 (5.00%) 
Eye disorders     
Blurred vision *  2/40 (5.00%)  1/40 (2.50%) 
Eye disorders - Other *  2/40 (5.00%)  1/40 (2.50%) 
Gastrointestinal disorders     
Constipation *  14/40 (35.00%)  14/40 (35.00%) 
Diarrhea *  10/40 (25.00%)  5/40 (12.50%) 
Dry mouth *  4/40 (10.00%)  3/40 (7.50%) 
Dyspepsia *  2/40 (5.00%)  2/40 (5.00%) 
Dysphagia *  5/40 (12.50%)  9/40 (22.50%) 
Gastroesophageal reflux disease *  2/40 (5.00%)  2/40 (5.00%) 
Mucositis oral *  16/40 (40.00%)  12/40 (30.00%) 
Nausea *  15/40 (37.50%)  14/40 (35.00%) 
Oral dysesthesia *  2/40 (5.00%)  3/40 (7.50%) 
Oral pain *  5/40 (12.50%)  1/40 (2.50%) 
Vomiting *  7/40 (17.50%)  6/40 (15.00%) 
General disorders     
Chills *  3/40 (7.50%)  2/40 (5.00%) 
Edema face *  7/40 (17.50%)  6/40 (15.00%) 
Edema limbs *  4/40 (10.00%)  4/40 (10.00%) 
Facial pain *  2/40 (5.00%)  3/40 (7.50%) 
Fatigue *  28/40 (70.00%)  30/40 (75.00%) 
Fever *  7/40 (17.50%)  8/40 (20.00%) 
Neck edema *  1/40 (2.50%)  3/40 (7.50%) 
Non-cardiac chest pain *  1/40 (2.50%)  7/40 (17.50%) 
Pain *  7/40 (17.50%)  12/40 (30.00%) 
Infections and infestations     
Infections and infestations - Other *  5/40 (12.50%)  5/40 (12.50%) 
Lung infection *  0/40 (0.00%)  2/40 (5.00%) 
Nail infection *  3/40 (7.50%)  0/40 (0.00%) 
Papulopustular rash *  2/40 (5.00%)  2/40 (5.00%) 
Paronychia *  3/40 (7.50%)  0/40 (0.00%) 
Sinusitis *  0/40 (0.00%)  2/40 (5.00%) 
Skin infection *  6/40 (15.00%)  2/40 (5.00%) 
Investigations     
Alanine aminotransferase increased *  11/40 (27.50%)  10/40 (25.00%) 
Alkaline phosphatase increased *  10/40 (25.00%)  7/40 (17.50%) 
Aspartate aminotransferase increased *  9/40 (22.50%)  7/40 (17.50%) 
CD4 lymphocytes decreased *  3/40 (7.50%)  0/40 (0.00%) 
Cholesterol high *  9/40 (22.50%)  10/40 (25.00%) 
Creatinine increased *  2/40 (5.00%)  6/40 (15.00%) 
INR increased *  0/40 (0.00%)  3/40 (7.50%) 
Lymphocyte count decreased *  14/40 (35.00%)  17/40 (42.50%) 
Neutrophil count decreased *  3/40 (7.50%)  4/40 (10.00%) 
Platelet count decreased *  16/40 (40.00%)  14/40 (35.00%) 
Weight loss *  8/40 (20.00%)  8/40 (20.00%) 
White blood cell decreased *  10/40 (25.00%)  11/40 (27.50%) 
Metabolism and nutrition disorders     
Anorexia *  11/40 (27.50%)  15/40 (37.50%) 
Dehydration *  3/40 (7.50%)  2/40 (5.00%) 
Hypercalcemia *  1/40 (2.50%)  2/40 (5.00%) 
Hyperglycemia *  18/40 (45.00%)  19/40 (47.50%) 
Hyperkalemia *  0/40 (0.00%)  2/40 (5.00%) 
Hypertriglyceridemia *  8/40 (20.00%)  10/40 (25.00%) 
Hypoalbuminemia *  13/40 (32.50%)  11/40 (27.50%) 
Hypocalcemia *  12/40 (30.00%)  7/40 (17.50%) 
Hypoglycemia *  4/40 (10.00%)  0/40 (0.00%) 
Hypokalemia *  15/40 (37.50%)  7/40 (17.50%) 
Hypomagnesemia *  22/40 (55.00%)  2/40 (5.00%) 
Hyponatremia *  5/40 (12.50%)  7/40 (17.50%) 
Hypophosphatemia *  12/40 (30.00%)  8/40 (20.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia *  3/40 (7.50%)  4/40 (10.00%) 
Back pain *  4/40 (10.00%)  3/40 (7.50%) 
Generalized muscle weakness *  3/40 (7.50%)  2/40 (5.00%) 
Myalgia *  1/40 (2.50%)  2/40 (5.00%) 
Neck pain *  2/40 (5.00%)  6/40 (15.00%) 
Pain in extremity *  2/40 (5.00%)  0/40 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain *  0/40 (0.00%)  2/40 (5.00%) 
Nervous system disorders     
Dizziness *  5/40 (12.50%)  4/40 (10.00%) 
Dysgeusia *  6/40 (15.00%)  5/40 (12.50%) 
Headache *  7/40 (17.50%)  7/40 (17.50%) 
Peripheral motor neuropathy *  3/40 (7.50%)  1/40 (2.50%) 
Peripheral sensory neuropathy *  5/40 (12.50%)  6/40 (15.00%) 
Psychiatric disorders     
Anxiety *  2/40 (5.00%)  3/40 (7.50%) 
Depression *  1/40 (2.50%)  8/40 (20.00%) 
Insomnia *  7/40 (17.50%)  7/40 (17.50%) 
Renal and urinary disorders     
Urinary frequency *  0/40 (0.00%)  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis *  2/40 (5.00%)  2/40 (5.00%) 
Cough *  10/40 (25.00%)  14/40 (35.00%) 
Dyspnea *  7/40 (17.50%)  11/40 (27.50%) 
Epistaxis *  5/40 (12.50%)  2/40 (5.00%) 
Hoarseness *  2/40 (5.00%)  0/40 (0.00%) 
Pneumonitis *  4/40 (10.00%)  3/40 (7.50%) 
Postnasal drip *  2/40 (5.00%)  1/40 (2.50%) 
Sore throat *  1/40 (2.50%)  2/40 (5.00%) 
Skin and subcutaneous tissue disorders     
Alopecia *  3/40 (7.50%)  1/40 (2.50%) 
Dry skin *  15/40 (37.50%)  3/40 (7.50%) 
Palmar-plantar erythrodysesthesia syndrome *  2/40 (5.00%)  1/40 (2.50%) 
Pruritus *  3/40 (7.50%)  3/40 (7.50%) 
Rash acneiform *  19/40 (47.50%)  5/40 (12.50%) 
Rash maculo-papular *  6/40 (15.00%)  5/40 (12.50%) 
Skin and subcutaneous tissue disorders - Other *  4/40 (10.00%)  1/40 (2.50%) 
Skin ulceration *  3/40 (7.50%)  1/40 (2.50%) 
Urticaria *  2/40 (5.00%)  0/40 (0.00%) 
Vascular disorders     
Hypertension *  3/40 (7.50%)  3/40 (7.50%) 
Hypotension *  2/40 (5.00%)  1/40 (2.50%) 
Lymphedema *  1/40 (2.50%)  2/40 (5.00%) 
*
Indicates events were collected by non-systematic assessment
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
Name/Title: Dr. Tanguy Seiwert
Organization: University of Chicago
Phone: (773) 702-2452
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01256385     History of Changes
Other Study ID Numbers: NCI-2011-02596
NCI-2011-02596 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000689896
UCCRC-10-428-B
10-428-B
10-428-B ( Other Identifier: University of Chicago Comprehensive Cancer Center P2C )
8692 ( Other Identifier: CTEP )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM00099 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
P30CA014599 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2010
First Posted: December 8, 2010
Results First Submitted: October 4, 2016
Results First Posted: February 6, 2017
Last Update Posted: March 27, 2017