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Radiation, Cetuximab and Pemetrexed With or Without Bevacizumab in Locally Advanced Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00703976
Recruitment Status : Completed
First Posted : June 24, 2008
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborators:
Eli Lilly and Company
Genentech, Inc.
Information provided by (Responsible Party):
University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Cancer
Interventions Drug: Bevacizumab
Drug: Cetuximab
Drug: Pemetrexed
Radiation: Radiation therapy
Enrollment 80
Recruitment Details  
Pre-assignment Details Although 80 patients were enrolled, only 78 began the study because 2 were found to be ineligible prior to treatment.
Arm/Group Title Cetuximab, Pemetrexed and Radiation Therapy Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab
Hide Arm/Group Description

Cetuximab, Pemetrexed and Radiation therapy

Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.

Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.

Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks

Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab

Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.

Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.

Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks

Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.

Period Title: Overall Study
Started 37 41
Completed 37 41
Not Completed 0 0
Arm/Group Title Cetuximab, Pemetrexed and Radiation Therapy Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab Total
Hide Arm/Group Description

Cetuximab, Pemetrexed and Radiation therapy

Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.

Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.

Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks

Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab

Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.

Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.

Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks

Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.

Total of all reporting groups
Overall Number of Baseline Participants 37 41 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants 41 participants 78 participants
57
(39 to 69)
56
(35 to 76)
56
(35 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 41 participants 78 participants
Female
5
  13.5%
10
  24.4%
15
  19.2%
Male
32
  86.5%
31
  75.6%
63
  80.8%
1.Primary Outcome
Title 2-year Progression-free Survival (PFS)
Hide Description Two-year PFS is an estimated percentage of participants without disease progression (locoregional or distant) at two years after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as: at least a 20% (and at least 5 millimeters) increase in the sum of the diameters of target lesions, or the appearance of one or more new lesions.
Time Frame 18 months to patient accrual and 2 years of follow-up after closing accrual.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cetuximab, Pemetrexed and Radiation Therapy Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab
Hide Arm/Group Description:

Cetuximab, Pemetrexed and Radiation therapy

Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.

Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.

Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks

Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab

Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.

Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.

Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks

Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.

Overall Number of Participants Analyzed 37 41
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
79
(69 to 92)
75
(64 to 88)
2.Secondary Outcome
Title 2-year Overall Survival (OS)
Hide Description Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.
Time Frame 2 years of follow-up after closing accrual
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants (Overall Study) Cetuximab, Pemetrexed and Radiation Therapy Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab
Hide Arm/Group Description:
[Not Specified]

Cetuximab, Pemetrexed and Radiation therapy

Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.

Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.

Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks

Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab

Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.

Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.

Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks

Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.

Overall Number of Participants Analyzed 78 37 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88
(81 to 96)
91
(82 to 100)
87
(77 to 98)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not collected/monitored "per Arm/Group"
 
Arm/Group Title All Participants (Overall Study)
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
All Participants (Overall Study)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants (Overall Study)
Affected / at Risk (%)
Total   31/78 (39.74%) 
Blood and lymphatic system disorders   
Hemoglobin  1/78 (1.28%) 
Febrile neutropenia (fever of unknown origin without documented infection)  2/78 (2.56%) 
Gastrointestinal disorders   
Constipation  3/78 (3.85%) 
Dysphagia (difficulty swallowing)  2/78 (2.56%) 
Gastrointestinal - Other  2/78 (2.56%) 
Leak (including anastomotic), GI, Leak NOS  1/78 (1.28%) 
Mucositis/stomatitis (clinical exam), Oral cavity  6/78 (7.69%) 
Mucositis/stomatitis (functional/symptomatic), Oral cavity  4/78 (5.13%) 
Nausea  4/78 (5.13%) 
Taste alteration (dysgeusia)  1/78 (1.28%) 
Ulcer, GI, Stomach  1/78 (1.28%) 
Vomiting  4/78 (5.13%) 
Hemorrhage, GI, Oral cavity  1/78 (1.28%) 
Pain, Abdomen NOS  2/78 (2.56%) 
Pain, Oral cavity  6/78 (7.69%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  2/78 (2.56%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  2/78 (2.56%) 
Infections and infestations   
Infection - Other  1/78 (1.28%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), Skin (cellulitis)  1/78 (1.28%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)  1/78 (1.28%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Meninges (meningitis)  1/78 (1.28%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis)  1/78 (1.28%) 
Investigations   
Leukocytes (total WBC)  1/78 (1.28%) 
Lymphopenia  1/78 (1.28%) 
Neutrophils/granulocytes (ANC/AGC)  2/78 (2.56%) 
Weight loss  1/78 (1.28%) 
Metabolism and nutrition disorders   
Dehydration  4/78 (5.13%) 
Calcium, serum-high (hypercalcemia)  1/78 (1.28%) 
Glucose, serum-high (hyperglycemia)  1/78 (1.28%) 
Nervous system disorders   
Dizziness  2/78 (2.56%) 
Syncope (fainting)  1/78 (1.28%) 
Pain, Head/headache  1/78 (1.28%) 
Psychiatric disorders   
Confusion  1/78 (1.28%) 
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, pulmonary/upper respiratory, Pharynx  1/78 (1.28%) 
Pain, Throat/pharynx/larynx  2/78 (2.56%) 
Cough  1/78 (1.28%) 
Dyspnea (shortness of breath)  1/78 (1.28%) 
Pneumonitis/pulmonary infiltrates  1/78 (1.28%) 
Skin and subcutaneous tissue disorders   
Pruritus/itching  1/78 (1.28%) 
Rash: acne/acneiform  1/78 (1.28%) 
Rash: dermatitis associated with radiation, Chemoradiation  1/78 (1.28%) 
Vascular disorders   
Hypotension  1/78 (1.28%) 
Thrombosis/thrombus/embolism  3/78 (3.85%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants (Overall Study)
Affected / at Risk (%)
Total   78/78 (100.00%) 
Blood and lymphatic system disorders   
Blood/Bone Marrow - Other  4/78 (5.13%) 
Hemoglobin  55/78 (70.51%) 
Coagulation - Other  1/78 (1.28%) 
Hemorrhage/Bleeding - Other  8/78 (10.26%) 
Febrile neutropenia (fever of unknown origin without documented infection)  2/78 (2.56%) 
Lymphatics - Other  4/78 (5.13%) 
Cardiac disorders   
Supraventricular and nodal arrhythmia, Sinus bradycardia  1/78 (1.28%) 
Supraventricular and nodal arrhythmia, Sinus tachycardia  2/78 (2.56%) 
Cardiac General - Other  4/78 (5.13%) 
Ear and labyrinth disorders   
Auditory/Ear - Other  3/78 (3.85%) 
Otitis, external ear (non-infectious)  2/78 (2.56%) 
Tinnitus  2/78 (2.56%) 
Pain, External ear  2/78 (2.56%) 
Endocrine disorders   
Endocrine - Other  1/78 (1.28%) 
Thyroid function, high (hyperthyroidism, thyrotoxicosis)  3/78 (3.85%) 
Thyroid function, low (hypothyroidism)  4/78 (5.13%) 
Eye disorders   
Dry eye syndrome  1/78 (1.28%) 
Vision-blurred vision  2/78 (2.56%) 
Vision-flashing lights/floaters  1/78 (1.28%) 
Vision-photophobia  2/78 (2.56%) 
Watery eye (epiphora, tearing)  1/78 (1.28%) 
Gastrointestinal disorders   
Constipation  36/78 (46.15%) 
Dental: dentures or prosthesis  2/78 (2.56%) 
Dental: teeth  6/78 (7.69%) 
Diarrhea  16/78 (20.51%) 
Distension/bloating, abdominal  1/78 (1.28%) 
Dry mouth/salivary gland (xerostomia)  52/78 (66.67%) 
Dysphagia (difficulty swallowing)  56/78 (71.79%) 
Esophagitis  1/78 (1.28%) 
Gastrointestinal - Other  16/78 (20.51%) 
Heartburn/dyspepsia  17/78 (21.79%) 
Hemorrhoids  1/78 (1.28%) 
Mucositis/stomatitis (clinical exam), Oral cavity  36/78 (46.15%) 
Mucositis/stomatitis (functional/symptomatic), Oral cavity  48/78 (61.54%) 
Nausea  45/78 (57.69%) 
Perforation, GI, Colon  1/78 (1.28%) 
Salivary gland changes/saliva  25/78 (32.05%) 
Taste alteration (dysgeusia)  36/78 (46.15%) 
Typhlitis (cecal inflammation)  1/78 (1.28%) 
Ulcer, GI, Duodenum  1/78 (1.28%) 
Ulcer, GI, Stomach  1/78 (1.28%) 
Vomiting  26/78 (33.33%) 
Hemorrhage, GI, Anus  1/78 (1.28%) 
Hemorrhage, GI, Oral cavity  1/78 (1.28%) 
Pain, Abdomen NOS  2/78 (2.56%) 
Pain, Dental/teeth/peridontal  1/78 (1.28%) 
Pain, Esophagus  3/78 (3.85%) 
Pain, Oral cavity  20/78 (25.64%) 
General disorders   
Constitutional Symptoms - Other  2/78 (2.56%) 
Fatigue (asthenia, lethargy, malaise)  57/78 (73.08%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  20/78 (25.64%) 
Rigors/chills  13/78 (16.67%) 
Injection site reaction/extravasation changes  1/78 (1.28%) 
Ulceration  11/78 (14.10%) 
Edema: head and neck  10/78 (12.82%) 
Edema: limb  3/78 (3.85%) 
Pain - Other  44/78 (56.41%) 
Pain, Face  3/78 (3.85%) 
Pain, Pain NOS  16/78 (20.51%) 
Flu-like syndrome  1/78 (1.28%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1/78 (1.28%) 
Infections and infestations   
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), Neck NOS  1/78 (1.28%) 
Infection - Other  35/78 (44.87%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Abdomen NOS  1/78 (1.28%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Foreign body  2/78 (2.56%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)  1/78 (1.28%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Neck NOS  1/78 (1.28%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Oral cavity-gums (gingivitis)  3/78 (3.85%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Upper aerodigestive NOS  1/78 (1.28%) 
Infection with unknown ANC, Dental-tooth  1/78 (1.28%) 
Infection with unknown ANC, Foreign body (e.g., graft, implant, prosthesis, stent)  1/78 (1.28%) 
Infection with unknown ANC, Neck NOS  1/78 (1.28%) 
Infection with unknown ANC, Skin (cellulitis)  2/78 (2.56%) 
Opportunistic infection associated with >=Grade 2 Lymphopenia  1/78 (1.28%) 
Injury, poisoning and procedural complications   
Burn  3/78 (3.85%) 
Wound complication, non-infectious  1/78 (1.28%) 
Fracture  1/78 (1.28%) 
Investigations   
Haptoglobin  1/78 (1.28%) 
Leukocytes (total WBC)  59/78 (75.64%) 
Lymphopenia  61/78 (78.21%) 
Neutrophils/granulocytes (ANC/AGC)  50/78 (64.10%) 
Platelets  25/78 (32.05%) 
Weight loss  50/78 (64.10%) 
ALT, SGPT (serum glutamic pyruvic transaminase)  37/78 (47.44%) 
AST, SGOT(serum glutamic oxaloacetic transaminase)  35/78 (44.87%) 
Alkaline phosphatase  13/78 (16.67%) 
Bicarbonate, serum-low  3/78 (3.85%) 
Bilirubin (hyperbilirubinemia)  6/78 (7.69%) 
Cholesterol, serum-high (hypercholesteremia)  3/78 (3.85%) 
Creatinine  1/78 (1.28%) 
Metabolism and nutrition disorders   
Anorexia  16/78 (20.51%) 
Dehydration  21/78 (26.92%) 
Albumin, serum-low (hypoalbuminemia)  55/78 (70.51%) 
Calcium, serum-high (hypercalcemia)  8/78 (10.26%) 
Calcium, serum-low (hypocalcemia)  35/78 (44.87%) 
Glucose, serum-high (hyperglycemia)  60/78 (76.92%) 
Glucose, serum-low (hypoglycemia)  5/78 (6.41%) 
Magnesium, serum-high (hypermagnesemia)  18/78 (23.08%) 
Magnesium, serum-low (hypomagnesemia)  17/78 (21.79%) 
Metabolic/Laboratory - Other  23/78 (29.49%) 
Phosphate, serum-low (hypophosphatemia)  16/78 (20.51%) 
Potassium, serum-high (hyperkalemia)  16/78 (20.51%) 
Potassium, serum-low (hypokalemia)  19/78 (24.36%) 
Sodium, serum-high (hypernatremia)  3/78 (3.85%) 
Sodium, serum-low (hyponatremia)  50/78 (64.10%) 
Musculoskeletal and connective tissue disorders   
Arthritis (non-septic)  1/78 (1.28%) 
Cervical spine-range of motion  1/78 (1.28%) 
Fibrosis-deep connective tissue  6/78 (7.69%) 
Joint-function  3/78 (3.85%) 
Muscle weakness, generalized or specific area (not due to neuropathy), Extremity-upper  1/78 (1.28%) 
Muscle weakness, generalized or specific area (not due to neuropathy), Whole body/generalized  2/78 (2.56%) 
Musculoskeletal/Soft Tissue - Other  16/78 (20.51%) 
Osteonecrosis (avascular necrosis)  2/78 (2.56%) 
Osteoporosis  1/78 (1.28%) 
Soft tissue necrosis, Neck  1/78 (1.28%) 
Trismus (difficulty, restriction or pain when opening mouth)  12/78 (15.38%) 
Pain, Back  2/78 (2.56%) 
Pain, Extremity-limb  3/78 (3.85%) 
Pain, Joint  1/78 (1.28%) 
Pain, Muscle  1/78 (1.28%) 
Pain, Neck  14/78 (17.95%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Pain, Tumor pain  1/78 (1.28%) 
Nervous system disorders   
Cognitive disturbance  1/78 (1.28%) 
Dizziness  9/78 (11.54%) 
Memory impairment  3/78 (3.85%) 
Neurology - Other  2/78 (2.56%) 
Neuropathy: sensory  3/78 (3.85%) 
Seizure  1/78 (1.28%) 
Syncope (fainting)  1/78 (1.28%) 
Tremor  3/78 (3.85%) 
Pain, Head/headache  28/78 (35.90%) 
Psychiatric disorders   
Insomnia  19/78 (24.36%) 
Confusion  3/78 (3.85%) 
Mental status  2/78 (2.56%) 
Mood alteration, Agitation  1/78 (1.28%) 
Mood alteration, Anxiety  11/78 (14.10%) 
Mood alteration, Depression  8/78 (10.26%) 
Psychosis (hallucinations/delusions)  1/78 (1.28%) 
Renal and urinary disorders   
Hemorrhage, GU, Urinary NOS  3/78 (3.85%) 
Proteinuria  5/78 (6.41%) 
Renal/Genitourinary - Other  3/78 (3.85%) 
Reproductive system and breast disorders   
Erectile dysfunction  1/78 (1.28%) 
Libido  1/78 (1.28%) 
Sexual/Reproductive Function - Other  1/78 (1.28%) 
Respiratory, thoracic and mediastinal disorders   
Mucositis/stomatitis (clinical exam), Larynx  1/78 (1.28%) 
Mucositis/stomatitis (clinical exam), Pharynx  1/78 (1.28%) 
Mucositis/stomatitis (functional/symptomatic), Pharynx  2/78 (2.56%) 
Hemorrhage, pulmonary/upper respiratory, Bronchopulmonary NOS  1/78 (1.28%) 
Hemorrhage, pulmonary/upper respiratory, Nose  11/78 (14.10%) 
Hemorrhage, pulmonary/upper respiratory, Pharynx  1/78 (1.28%) 
Hemorrhage, pulmonary/upper respiratory, Respiratory tract NOS  1/78 (1.28%) 
Pain, Chest/thorax NOS  2/78 (2.56%) 
Pain, Larynx  2/78 (2.56%) 
Pain, Throat/pharynx/larynx  35/78 (44.87%) 
Aspiration  4/78 (5.13%) 
Atelectasis  1/78 (1.28%) 
Bronchospasm, wheezing  2/78 (2.56%) 
Cough  14/78 (17.95%) 
Dyspnea (shortness of breath)  7/78 (8.97%) 
Hiccoughs (hiccups, singultus)  2/78 (2.56%) 
Hypoxia  1/78 (1.28%) 
Pleural effusion (non-malignant)  1/78 (1.28%) 
Pneumonitis/pulmonary infiltrates  0/78 (0.00%) 
Pulmonary/Upper Respiratory - Other  7/78 (8.97%) 
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)  30/78 (38.46%) 
Skin and subcutaneous tissue disorders   
Sweating (diaphoresis)  1/78 (1.28%) 
Dermatology/Skin - Other  21/78 (26.92%) 
Dry skin  44/78 (56.41%) 
Hair loss/alopecia (scalp or body)  6/78 (7.69%) 
Hyperpigmentation  2/78 (2.56%) 
Hypopigmentation  1/78 (1.28%) 
Nail changes  1/78 (1.28%) 
Pruritus/itching  13/78 (16.67%) 
Rash/desquamation  4/78 (5.13%) 
Rash: acne/acneiform  55/78 (70.51%) 
Rash: dermatitis associated with radiation, Chemoradiation  33/78 (42.31%) 
Rash: dermatitis associated with radiation, Radiation  52/78 (66.67%) 
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)  4/78 (5.13%) 
Rash: hand-foot skin reaction  1/78 (1.28%) 
Skin breakdown/decubitus ulcer  1/78 (1.28%) 
Pain, Skin  1/78 (1.28%) 
Vascular disorders   
Hypertension  12/78 (15.38%) 
Hypotension  7/78 (8.97%) 
INR (International Normalized Ratio of prothrombin time)  6/78 (7.69%) 
PTT (Partial Thromboplastin Time)  3/78 (3.85%) 
Phlebitis (including superficial thrombosis)  1/78 (1.28%) 
Thrombosis/thrombus/embolism  1/78 (1.28%) 
Vascular - Other  1/78 (1.28%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Julie Bauman, MD
Organization: University of Pittsburgh
Phone: 412-623-7833
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00703976     History of Changes
Other Study ID Numbers: 07-021
First Submitted: June 20, 2008
First Posted: June 24, 2008
Results First Submitted: January 14, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017