Trial Outcomes & Findings for A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer (NCT NCT00409565)
NCT ID: NCT00409565
Last Updated: 2017-10-20
Results Overview
ORR is the percentage of patients whose cancer shrunk or disappeared after study treatment. ORR was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2017-10-20
Participant Flow
We report results in 46 eligible patients. Two patients were deemed ineligible, one because subsequent biopsy showed that measurable disease was actually steoradionecrosis and not recurrent laryngeal cancer. The other patient required surgery for cholecystitis before starting treatment; this patient never initiated protocol treatment.
Participant milestones
| Measure |
Cetuximab Plus Bevacizumab
Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
Overall Response Rate
|
7
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab Plus Bevacizumab
n=46 Participants
Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
|
|---|---|
|
Age, Continuous
|
61.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
|
Primary disease site
Oropharynx
|
17 participants
n=5 Participants
|
|
Primary disease site
Oral cavity
|
14 participants
n=5 Participants
|
|
Primary disease site
Larynx
|
7 participants
n=5 Participants
|
|
Primary disease site
Others
|
8 participants
n=5 Participants
|
|
Recurrent disease
|
44 participants
n=5 Participants
|
|
Prior radiation
|
44 participants
n=5 Participants
|
|
Prior surgery
|
30 participants
n=5 Participants
|
|
Prior chemotherapy
Prior chemotherapy
|
42 participants
n=5 Participants
|
|
Prior chemotherapy
1 prior palliative regimen
|
17 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
11 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
31 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Assess all patients included in this study for response to treatment, per protocol. Of 46 eligible patients, 45 were evaluable for response.
ORR is the percentage of patients whose cancer shrunk or disappeared after study treatment. ORR was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Cetuximab Plus Bevacizumab
n=45 Participants
Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
|
|---|---|
|
Objective Response Rate (ORR)
|
16 percentage of participants
Interval 7.0 to 24.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All patients included in study are assessed for response to treatment, per protocol. Of 46 eligible patients, 45 were evaluable for response.
PFS is the length of time during and after treatment that patients are alive with the disease but it does not get worse. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI), Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Cetuximab Plus Bevacizumab
n=45 Participants
Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
|
|---|---|
|
Progression-free Survival (PFS)
|
2.8 Months
Interval 2.7 to 4.2
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe length of time from the start of study/treatment that diagnosed patients are still alive.
Outcome measures
| Measure |
Cetuximab Plus Bevacizumab
n=45 Participants
Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
|
|---|---|
|
Overall Survival (OS)
|
7.5 months
Interval 5.7 to 9.6
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients treated with cetuximab and bevacizumab who provided baseline and post-treatment serum samples.
Ratio of serum cytokines concentration after treatment with cetuximab and bevacizumab to baseline serum cytokines concentration, in picogram/milliliter (pg/ml) for 13 different cytokines. \[post-treatment (pg/ml) / baseline (pg/ml)\]
Outcome measures
| Measure |
Cetuximab Plus Bevacizumab
n=20 Participants
Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
|
|---|---|
|
Change in Serum Cytokine Concentrations
TGFa
|
3.3711 post-treatment/baseline pg/ml ratio
|
|
Change in Serum Cytokine Concentrations
PIGF
|
1.9453 post-treatment/baseline pg/ml ratio
|
|
Change in Serum Cytokine Concentrations
VEGF
|
0.1203 post-treatment/baseline pg/ml ratio
|
|
Change in Serum Cytokine Concentrations
EGFR
|
1.5875 post-treatment/baseline pg/ml ratio
|
|
Change in Serum Cytokine Concentrations
IP.10
|
1.25 post-treatment/baseline pg/ml ratio
|
|
Change in Serum Cytokine Concentrations
VEGFR.2
|
1.1032 post-treatment/baseline pg/ml ratio
|
|
Change in Serum Cytokine Concentrations
FGFb
|
0.7346 post-treatment/baseline pg/ml ratio
|
|
Change in Serum Cytokine Concentrations
FGFa
|
0.0000 post-treatment/baseline pg/ml ratio
|
|
Change in Serum Cytokine Concentrations
IL.6
|
1.3831 post-treatment/baseline pg/ml ratio
|
|
Change in Serum Cytokine Concentrations
HGF
|
0.9622 post-treatment/baseline pg/ml ratio
|
|
Change in Serum Cytokine Concentrations
GCSF
|
1.2652 post-treatment/baseline pg/ml ratio
|
|
Change in Serum Cytokine Concentrations
EGF
|
0.7878 post-treatment/baseline pg/ml ratio
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: Patients that were evaluable for 'best response' to treatment.
Disease Control Rate (DCR) (or Clinical Benefit Rate (CBR)), is defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to cetuximab and bevacizumab. DCR = number of patients with (at least) partial response or stable disease / total number of evaluable patients
Outcome measures
| Measure |
Cetuximab Plus Bevacizumab
n=45 Participants
Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
|
|---|---|
|
Disease Control Rate (DCR) ((Clinical Benefit Rate (CBR))
|
73 percentage of participants
|
Adverse Events
Cetuximab Plus Bevacizumab
Serious events: 22 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab Plus Bevacizumab
n=46 participants at risk
Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
|
|---|---|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
2.2%
1/46
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.2%
1/46
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.2%
1/46
|
|
Vascular disorders
Hypertension
|
2.2%
1/46
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Anorexia
|
4.3%
2/46
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
2/46
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
15.2%
7/46
|
|
Gastrointestinal disorders
Stricture/stenosis (including anastomotic), GI, Esophagus
|
2.2%
1/46
|
|
Gastrointestinal disorders
Stricture/stenosis (including anastomotic), GI, Pharynx
|
2.2%
1/46
|
|
Gastrointestinal disorders
Pain, Abdomen NOS
|
4.3%
2/46
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory, Bronchopulmonary NOS
|
2.2%
1/46
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils, Lung (pneumonia)
|
4.3%
2/46
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
|
2.2%
1/46
|
|
Infections and infestations
Infection with unknown ANC, Esophagus
|
2.2%
1/46
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
2.2%
1/46
|
|
Investigations
Creatinine increased
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
2.2%
1/46
|
|
Renal and urinary disorders
Proteinuria
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Trismus (difficulty, restriction or pain when opening mouth)
|
4.3%
2/46
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46
|
|
Psychiatric disorders
Mood alteration, Depression
|
2.2%
1/46
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
2.2%
1/46
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
2.2%
1/46
|
|
Nervous system disorders
Pain, Head/headache
|
2.2%
1/46
|
|
Gastrointestinal disorders
Pain, Oral cavity
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Pain, Throat/pharynx/larynx
|
2.2%
1/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain, Tumor pain
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
4.3%
2/46
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction/stenosis of airway, Larynx
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
2.2%
1/46
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.2%
1/46
|
Other adverse events
| Measure |
Cetuximab Plus Bevacizumab
n=46 participants at risk
Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
23.9%
11/46
|
|
Cardiac disorders
Cardiac disorders - Other
|
2.2%
1/46
|
|
Cardiac disorders
Sinus tachycardia
|
4.3%
2/46
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
2.2%
1/46
|
|
Ear and labyrinth disorders
Ear pain
|
4.3%
2/46
|
|
Ear and labyrinth disorders
External ear pain
|
8.7%
4/46
|
|
Ear and labyrinth disorders
Tinnitus
|
6.5%
3/46
|
|
Endocrine disorders
Hypothyroidism
|
4.3%
2/46
|
|
Eye disorders
Blurred vision
|
4.3%
2/46
|
|
Eye disorders
Cataract
|
2.2%
1/46
|
|
Eye disorders
Conjunctivitis
|
4.3%
2/46
|
|
Eye disorders
Eye disorders - Other
|
2.2%
1/46
|
|
Eye disorders
Eye pain
|
2.2%
1/46
|
|
Eye disorders
Eyelid function disorder
|
4.3%
2/46
|
|
Eye disorders
Watering eyes
|
4.3%
2/46
|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
4/46
|
|
Gastrointestinal disorders
Constipation
|
28.3%
13/46
|
|
Gastrointestinal disorders
Diarrhea
|
23.9%
11/46
|
|
Gastrointestinal disorders
Dry mouth
|
21.7%
10/46
|
|
Gastrointestinal disorders
Dyspepsia
|
15.2%
7/46
|
|
Gastrointestinal disorders
Dysphagia
|
37.0%
17/46
|
|
Gastrointestinal disorders
Esophageal pain
|
2.2%
1/46
|
|
Gastrointestinal disorders
Flatulence
|
2.2%
1/46
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/46
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
13.0%
6/46
|
|
Gastrointestinal disorders
Mucositis oral
|
17.4%
8/46
|
|
Gastrointestinal disorders
Nausea
|
47.8%
22/46
|
|
Gastrointestinal disorders
Oral hemorrhage
|
6.5%
3/46
|
|
Gastrointestinal disorders
Oral pain
|
30.4%
14/46
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.2%
1/46
|
|
Gastrointestinal disorders
Stomach pain
|
2.2%
1/46
|
|
Gastrointestinal disorders
Vomiting
|
21.7%
10/46
|
|
General disorders
Chills
|
15.2%
7/46
|
|
General disorders
Edema face
|
13.0%
6/46
|
|
General disorders
Edema limbs
|
4.3%
2/46
|
|
General disorders
Facial pain
|
4.3%
2/46
|
|
General disorders
Fatigue
|
67.4%
31/46
|
|
General disorders
Fever
|
15.2%
7/46
|
|
General disorders
General disorders and administration site conditions - Other
|
6.5%
3/46
|
|
General disorders
Non-cardiac chest pain
|
6.5%
3/46
|
|
General disorders
Pain
|
21.7%
10/46
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
2.2%
1/46
|
|
Immune system disorders
Allergic reaction
|
4.3%
2/46
|
|
Infections and infestations
Bronchial infection
|
2.2%
1/46
|
|
Infections and infestations
Catheter related infection
|
2.2%
1/46
|
|
Infections and infestations
Esophageal infection
|
2.2%
1/46
|
|
Infections and infestations
Gum infection
|
2.2%
1/46
|
|
Infections and infestations
Infections and infestations - Other
|
10.9%
5/46
|
|
Infections and infestations
Joint infection
|
2.2%
1/46
|
|
Infections and infestations
Lip infection
|
2.2%
1/46
|
|
Infections and infestations
Lung infection
|
2.2%
1/46
|
|
Infections and infestations
Mucosal infection
|
4.3%
2/46
|
|
Infections and infestations
Nail infection
|
2.2%
1/46
|
|
Infections and infestations
Otitis externa
|
2.2%
1/46
|
|
Infections and infestations
Otitis media
|
2.2%
1/46
|
|
Infections and infestations
Rhinitis infective
|
2.2%
1/46
|
|
Infections and infestations
Skin infection
|
8.7%
4/46
|
|
Infections and infestations
Upper respiratory infection
|
4.3%
2/46
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/46
|
|
Infections and infestations
Wound infection
|
2.2%
1/46
|
|
Injury, poisoning and procedural complications
Bruising
|
2.2%
1/46
|
|
Injury, poisoning and procedural complications
Injury to jugular vein
|
2.2%
1/46
|
|
Injury, poisoning and procedural complications
Intestinal stoma site bleeding
|
2.2%
1/46
|
|
Injury, poisoning and procedural complications
Intraoperative head and neck injury
|
2.2%
1/46
|
|
Injury, poisoning and procedural complications
Venous injury
|
2.2%
1/46
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.2%
1/46
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
2/46
|
|
Investigations
Alkaline phosphatase increased
|
2.2%
1/46
|
|
Investigations
Aspartate aminotransferase increased
|
10.9%
5/46
|
|
Investigations
Creatinine increased
|
4.3%
2/46
|
|
Investigations
Lymphocyte count decreased
|
8.7%
4/46
|
|
Investigations
Platelet count decreased
|
2.2%
1/46
|
|
Investigations
Weight loss
|
23.9%
11/46
|
|
Investigations
White blood cell decreased
|
8.7%
4/46
|
|
Metabolism and nutrition disorders
Anorexia
|
34.8%
16/46
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
3/46
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.5%
3/46
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
19.6%
9/46
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.5%
3/46
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.0%
6/46
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.5%
3/46
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.7%
4/46
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
23.9%
11/46
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.0%
6/46
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.6%
9/46
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.3%
2/46
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.9%
5/46
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.5%
3/46
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.0%
6/46
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.7%
4/46
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.0%
6/46
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
13.0%
6/46
|
|
Nervous system disorders
Dizziness
|
8.7%
4/46
|
|
Nervous system disorders
Dysarthria
|
2.2%
1/46
|
|
Nervous system disorders
Dysgeusia
|
4.3%
2/46
|
|
Nervous system disorders
Dysphasia
|
8.7%
4/46
|
|
Nervous system disorders
Facial nerve disorder
|
2.2%
1/46
|
|
Nervous system disorders
Headache
|
43.5%
20/46
|
|
Nervous system disorders
Nervous system disorders - Other
|
6.5%
3/46
|
|
Nervous system disorders
Neuralgia
|
2.2%
1/46
|
|
Nervous system disorders
Olfactory nerve disorder
|
2.2%
1/46
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.9%
5/46
|
|
Nervous system disorders
Syncope
|
2.2%
1/46
|
|
Nervous system disorders
Tremor
|
2.2%
1/46
|
|
Nervous system disorders
Trigeminal nerve disorder
|
2.2%
1/46
|
|
Psychiatric disorders
Anxiety
|
15.2%
7/46
|
|
Psychiatric disorders
Confusion
|
2.2%
1/46
|
|
Psychiatric disorders
Depression
|
13.0%
6/46
|
|
Psychiatric disorders
Insomnia
|
15.2%
7/46
|
|
Renal and urinary disorders
Hematuria
|
2.2%
1/46
|
|
Renal and urinary disorders
Proteinuria
|
4.3%
2/46
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
2.2%
1/46
|
|
Renal and urinary disorders
Urinary frequency
|
4.3%
2/46
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.7%
4/46
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.9%
5/46
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.4%
8/46
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.7%
4/46
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal stenosis
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
17.4%
8/46
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.3%
2/46
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
4.3%
2/46
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
6.5%
3/46
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
6.5%
3/46
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
1/46
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
41.3%
19/46
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.5%
3/46
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.5%
3/46
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
8.7%
4/46
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.2%
1/46
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.5%
3/46
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.1%
12/46
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
69.6%
32/46
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.4%
14/46
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.2%
1/46
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
17.4%
8/46
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
10.9%
5/46
|
|
Vascular disorders
Flushing
|
4.3%
2/46
|
|
Vascular disorders
Hematoma
|
4.3%
2/46
|
|
Vascular disorders
Hypertension
|
15.2%
7/46
|
|
Vascular disorders
Hypotension
|
6.5%
3/46
|
|
Vascular disorders
Peripheral ischemia
|
2.2%
1/46
|
|
Vascular disorders
Vascular disorders - Other
|
8.7%
4/46
|
Additional Information
Michael Gibson, MD
University of Pittsburgh Cancer Institute
Phone: 412-692-2600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60