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Trial record 83 of 165 for:    PEMT

Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction

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ClinicalTrials.gov Identifier: NCT00757172
Recruitment Status : Completed
First Posted : September 23, 2008
Results First Posted : August 19, 2014
Last Update Posted : March 11, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Amgen
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Interventions Biological: panitumumab
Drug: cisplatin
Drug: docetaxel
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Enrollment 70
Recruitment Details Seventy participants were recruited between January 2009 to July 2011 from 24 institutions.
Pre-assignment Details Five participants were declared ineligible. One participant had a celiac lymph node >2 cm and one participant had two primary tumors. Liver lesions were noted and not investigated in one participant. Two participants had Siewert type III tumors. These five participants were excluded from all analysis except adverse events.
Arm/Group Title Docetaxel + Cisplatin + Panitumumab + RT
Hide Arm/Group Description Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Period Title: Overall Study
Started 65
Completed 54 [1]
Not Completed 11
Reason Not Completed
Withdrawal by Subject             4
Physician Decision             3
Progression             4
[1]
Participants underwent surgery.
Arm/Group Title Docetaxel + Cisplatin + Panitumumab + RT
Hide Arm/Group Description Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
All registered participants who have met the eligibility criteria.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 65 participants
61
(30 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Female
6
   9.2%
Male
59
  90.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.5%
White
64
  98.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 65 participants
65
Eastern Cooperative Oncology Group (ECOG) performance status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants
0= Asymptomatic and fully active 37
1= Symptomatic; fully ambulatory 28
Body Mass Index (BMI)  
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 65 participants
27.8
(17.7 to 53.5)
Tumor location (Siewert Type)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants
I 36
II 29
[1]
Measure Description: Siewert Type I= Adenocarcinoma of the distal esophagus; Siewert Type II= Adenocarcinoma of the esophagogastric junction/real cardia
Clinical T Stage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants
T2 = Tumor invades muscularis propria 7
T3= Tumor invades adventitia 58
Clinical N Stage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants
N0= No regional lymph node metastasis 13
N1= Regional lymph node metastasis 52
Clinical M Stage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants
M0= No distant metastasis 56
M1a= Metastasis in celiac or cervical lymph nodes 9
1.Primary Outcome
Title Number of Participants With Pathologic Complete Response Following Surgery
Hide Description Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.
Time Frame Post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have met the eligibility criteria that have signed a consent form and began treatment.
Arm/Group Title Docetaxel + Cisplatin + Panitumumab + RT
Hide Arm/Group Description:
Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
18
2.Secondary Outcome
Title Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)
Hide Description [Not Specified]
Time Frame Post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have met the eligibility criteria that have signed a consent form and began treatment.
Arm/Group Title Docetaxel + Cisplatin + Panitumumab + RT
Hide Arm/Group Description:
Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
11
3.Secondary Outcome
Title Percentage of Participants With 3-year Overall Survival
Hide Description Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All registered participants who have met the eligibility criteria.
Arm/Group Title Docetaxel + Cisplatin + Panitumumab + RT
Hide Arm/Group Description:
Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: percentage of participants
38.6
4.Secondary Outcome
Title Percentage of Participants With 2-year Disease-free Survival
Hide Description Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All registered participants who have met the eligibility criteria.
Arm/Group Title Docetaxel + Cisplatin + Panitumumab + RT
Hide Arm/Group Description:
Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: percentage of participants
41.4
5.Secondary Outcome
Title Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution
Hide Description Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.
Time Frame Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
All recruited participants.
Arm/Group Title Docetaxel + Cisplatin + Panitumumab + RT
Hide Arm/Group Description:
Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: participants
Hemoglobin 12
Lymphocytes 30
Neutrophils 12
Dehydration 13
Esophagitis 13
Nausea 11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Docetaxel + Cisplatin + Panitumumab + RT
Hide Arm/Group Description Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
All-Cause Mortality
Docetaxel + Cisplatin + Panitumumab + RT
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Docetaxel + Cisplatin + Panitumumab + RT
Affected / at Risk (%) # Events
Total   46/70 (65.71%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  3/70 (4.29%)  3
Hemoglobin decreased  1  11/70 (15.71%)  12
Cardiac disorders   
Atrial fibrillation  1  4/70 (5.71%)  5
Atrial flutter  1  1/70 (1.43%)  1
Sinus tachycardia  1  2/70 (2.86%)  2
Supraventricular tachycardia  1  1/70 (1.43%)  1
Gastrointestinal disorders   
Abdominal pain  1  2/70 (2.86%)  3
Anal pain  1  1/70 (1.43%)  1
Constipation  1  1/70 (1.43%)  1
Diarrhea  1  4/70 (5.71%)  5
Dry mouth  1  1/70 (1.43%)  1
Dysphagia  1  4/70 (5.71%)  4
Ear, nose and throat examination abnormal  1  2/70 (2.86%)  2
Esophageal fistula  1  2/70 (2.86%)  2
Esophageal hemorrhage  1  1/70 (1.43%)  1
Esophageal pain  1  1/70 (1.43%)  1
Esophageal perforation  1  1/70 (1.43%)  1
Esophageal ulcer  1  1/70 (1.43%)  1
Esophagitis  1  7/70 (10.00%)  8
Gastrointestinal disorder  1  2/70 (2.86%)  2
Gastrointestinal pain  1  1/70 (1.43%)  1
Lower gastrointestinal hemorrhage  1  1/70 (1.43%)  1
Malabsorption  1  1/70 (1.43%)  1
Nausea  1  10/70 (14.29%)  11
Upper gastrointestinal hemorrhage  1  1/70 (1.43%)  1
Vomiting  1  9/70 (12.86%)  9
General disorders   
Edema limbs  1  1/70 (1.43%)  1
Fatigue  1  2/70 (2.86%)  3
General symptom  1  1/70 (1.43%)  1
Multi-organ failure  1  1/70 (1.43%)  1
Infections and infestations   
Catheter related infection  1  1/70 (1.43%)  1
Device related infection  1  1/70 (1.43%)  1
Endocarditis infective  1  1/70 (1.43%)  1
Infection  1  5/70 (7.14%)  5
Pleural infection  1  1/70 (1.43%)  1
Pneumonia  1  3/70 (4.29%)  3
Sepsis  1  1/70 (1.43%)  1
Skin infection  1  1/70 (1.43%)  1
Upper respiratory infection  1  2/70 (2.86%)  2
Urinary tract infection  1  2/70 (2.86%)  2
Wound infection  1  3/70 (4.29%)  3
Injury, poisoning and procedural complications   
Esophageal anastomotic leak  1  2/70 (2.86%)  2
Gastrointestinal anastomotic leak  1  1/70 (1.43%)  1
Intraoperative gastrointestinal injury - Esophagus  1  1/70 (1.43%)  1
Vascular access complication  1  1/70 (1.43%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  3/70 (4.29%)  3
Alanine aminotransferase increased  1  1/70 (1.43%)  1
Aspartate aminotransferase increased  1  2/70 (2.86%)  2
Bilirubin increased  1  2/70 (2.86%)  2
Cardiac troponin I increased  1  1/70 (1.43%)  1
Creatinine increased  1  1/70 (1.43%)  1
INR increased  1  1/70 (1.43%)  1
Laboratory test abnormal  1  1/70 (1.43%)  3
Leukocyte count decreased  1  8/70 (11.43%)  9
Lymphocyte count decreased  1  15/70 (21.43%)  18
Neutrophil count decreased  1  6/70 (8.57%)  7
Platelet count decreased  1  2/70 (2.86%)  2
Weight loss  1  1/70 (1.43%)  1
Metabolism and nutrition disorders   
Acidosis  1  2/70 (2.86%)  2
Alkalosis  1  2/70 (2.86%)  2
Anorexia  1  3/70 (4.29%)  4
Blood glucose increased  1  3/70 (4.29%)  3
Dehydration  1  10/70 (14.29%)  10
Serum albumin decreased  1  9/70 (12.86%)  10
Serum calcium decreased  1  5/70 (7.14%)  5
Serum magnesium decreased  1  2/70 (2.86%)  2
Serum phosphate decreased  1  4/70 (5.71%)  4
Serum potassium decreased  1  4/70 (5.71%)  5
Serum potassium increased  1  1/70 (1.43%)  1
Serum sodium decreased  1  3/70 (4.29%)  5
Serum sodium increased  1  1/70 (1.43%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness  1  2/70 (2.86%)  3
Myalgia  1  1/70 (1.43%)  1
Nervous system disorders   
Depressed level of consciousness  1  1/70 (1.43%)  1
Dizziness  1  1/70 (1.43%)  1
Encephalopathy  1  1/70 (1.43%)  1
Headache  1  1/70 (1.43%)  1
Ischemia cerebrovascular  1  1/70 (1.43%)  1
Peripheral sensory neuropathy  1  1/70 (1.43%)  1
Syncope  1  2/70 (2.86%)  2
Psychiatric disorders   
Agitation  1  1/70 (1.43%)  1
Confusion  1  1/70 (1.43%)  1
Renal and urinary disorders   
Renal failure  1  2/70 (2.86%)  2
Urogenital disorder  1  1/70 (1.43%)  1
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome  1  2/70 (2.86%)  2
Chylothorax  1  2/70 (2.86%)  2
Cough  1  1/70 (1.43%)  1
Dyspnea  1  6/70 (8.57%)  6
Hypoxia  1  3/70 (4.29%)  3
Pleural effusion  1  5/70 (7.14%)  5
Pneumonitis  1  2/70 (2.86%)  2
Pneumothorax  1  1/70 (1.43%)  1
Respiratory disorder  1  3/70 (4.29%)  3
Skin and subcutaneous tissue disorders   
Decubitus ulcer  1  1/70 (1.43%)  1
Rash acneiform  1  1/70 (1.43%)  1
Rash desquamating  1  2/70 (2.86%)  2
Vascular disorders   
Hematoma  1  1/70 (1.43%)  1
Hypotension  1  3/70 (4.29%)  3
Thrombosis  1  10/70 (14.29%)  13
Visceral arterial ischemia  1  1/70 (1.43%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Docetaxel + Cisplatin + Panitumumab + RT
Affected / at Risk (%) # Events
Total   70/70 (100.00%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  3/70 (4.29%)  3
Hemoglobin decreased  1  39/70 (55.71%)  139
Hemolysis  1  4/70 (5.71%)  4
Lymphatic disorder  1  1/70 (1.43%)  1
Cardiac disorders   
Arrhythmia  1  2/70 (2.86%)  2
Arrhythmia supraventricular  1  1/70 (1.43%)  1
Atrial fibrillation  1  8/70 (11.43%)  8
Atrial tachycardia  1  2/70 (2.86%)  2
Cardiac disorder  1  2/70 (2.86%)  2
Conduction disorder  1  1/70 (1.43%)  1
Left ventricular failure  1  1/70 (1.43%)  1
Palpitations  1  2/70 (2.86%)  2
Pericardial effusion  1  1/70 (1.43%)  1
Premature ventricular contractions  1  1/70 (1.43%)  1
Sinus tachycardia  1  2/70 (2.86%)  2
Supraventricular tachycardia  1  1/70 (1.43%)  1
Ear and labyrinth disorders   
Ear disorder  1  1/70 (1.43%)  1
Hearing loss  1  3/70 (4.29%)  12
Eye disorders   
Diplopia  1  1/70 (1.43%)  1
Dry eye syndrome  1  1/70 (1.43%)  1
Eye disorder  1  1/70 (1.43%)  2
Eyelid function disorder  1  1/70 (1.43%)  1
Vision blurred  1  2/70 (2.86%)  2
Watering eyes  1  2/70 (2.86%)  4
Gastrointestinal disorders   
Abdominal distension  1  2/70 (2.86%)  4
Abdominal pain  1  8/70 (11.43%)  14
Anal exam abnormal  1  2/70 (2.86%)  5
Ascites  1  1/70 (1.43%)  1
Cheilitis  1  1/70 (1.43%)  1
Constipation  1  18/70 (25.71%)  32
Diarrhea  1  37/70 (52.86%)  76
Dry mouth  1  1/70 (1.43%)  1
Dyspepsia  1  12/70 (17.14%)  27
Dysphagia  1  30/70 (42.86%)  49
Ear, nose and throat examination abnormal  1  13/70 (18.57%)  22
Esophageal pain  1  4/70 (5.71%)  7
Esophagitis  1  36/70 (51.43%)  77
Flatulence  1  1/70 (1.43%)  1
Gastrointestinal disorder  1  10/70 (14.29%)  18
Gingival pain  1  2/70 (2.86%)  4
Hemorrhoids  1  1/70 (1.43%)  1
Mucositis oral  1  8/70 (11.43%)  11
Nausea  1  49/70 (70.00%)  125
Oesophagoscopy abnormal  1  1/70 (1.43%)  1
Rectal hemorrhage  1  1/70 (1.43%)  1
Rectal pain  1  1/70 (1.43%)  1
Stomach pain  1  1/70 (1.43%)  2
Upper gastrointestinal hemorrhage  1  1/70 (1.43%)  1
Vomiting  1  28/70 (40.00%)  44
General disorders   
Chest pain  1  3/70 (4.29%)  3
Chills  1  7/70 (10.00%)  10
Edema limbs  1  4/70 (5.71%)  6
Fatigue  1  50/70 (71.43%)  162
Fever  1  7/70 (10.00%)  10
General symptom  1  1/70 (1.43%)  1
Injection site reaction  1  2/70 (2.86%)  2
Localized edema  1  1/70 (1.43%)  1
Pain  1  11/70 (15.71%)  22
Immune system disorders   
Cytokine release syndrome  1  1/70 (1.43%)  2
Hypersensitivity  1  13/70 (18.57%)  16
Infections and infestations   
Bronchitis  1  1/70 (1.43%)  1
Catheter related infection  1  1/70 (1.43%)  1
Eye infection  1  2/70 (2.86%)  2
Infection  1  5/70 (7.14%)  7
Opportunistic infection  1  1/70 (1.43%)  1
Paranasal sinus infection  1  1/70 (1.43%)  1
Pleural infection  1  1/70 (1.43%)  1
Pneumonia  1  1/70 (1.43%)  1
Sepsis  1  3/70 (4.29%)  3
Skin infection  1  1/70 (1.43%)  1
Upper respiratory infection  1  1/70 (1.43%)  2
Urinary tract infection  1  1/70 (1.43%)  1
Wound infection  1  4/70 (5.71%)  4
Injury, poisoning and procedural complications   
Bruising  1  1/70 (1.43%)  1
Dermatitis radiation  1  9/70 (12.86%)  14
Esophageal anastomotic leak  1  1/70 (1.43%)  1
Thermal burn  1  1/70 (1.43%)  2
Investigations   
Activated partial thromboplastin time prolonged  1  1/70 (1.43%)  1
Alanine aminotransferase increased  1  17/70 (24.29%)  24
Alkaline phosphatase increased  1  10/70 (14.29%)  20
Aspartate aminotransferase increased  1  19/70 (27.14%)  25
Bilirubin increased  1  8/70 (11.43%)  12
Creatinine increased  1  15/70 (21.43%)  21
INR increased  1  2/70 (2.86%)  2
Laboratory test abnormal  1  3/70 (4.29%)  22
Leukocyte count decreased  1  56/70 (80.00%)  156
Lymphocyte count decreased  1  29/70 (41.43%)  79
Neutrophil count decreased  1  18/70 (25.71%)  30
Platelet count decreased  1  40/70 (57.14%)  91
Weight gain  1  1/70 (1.43%)  1
Weight loss  1  19/70 (27.14%)  30
Metabolism and nutrition disorders   
Anorexia  1  30/70 (42.86%)  67
Blood bicarbonate decreased  1  2/70 (2.86%)  3
Blood glucose increased  1  30/70 (42.86%)  73
Blood uric acid increased  1  1/70 (1.43%)  1
Dehydration  1  20/70 (28.57%)  29
Serum albumin decreased  1  28/70 (40.00%)  85
Serum calcium decreased  1  23/70 (32.86%)  49
Serum calcium increased  1  1/70 (1.43%)  1
Serum glucose decreased  1  2/70 (2.86%)  3
Serum magnesium decreased  1  36/70 (51.43%)  90
Serum magnesium increased  1  8/70 (11.43%)  9
Serum phosphate decreased  1  9/70 (12.86%)  17
Serum potassium decreased  1  18/70 (25.71%)  31
Serum potassium increased  1  10/70 (14.29%)  12
Serum sodium decreased  1  16/70 (22.86%)  35
Serum sodium increased  1  7/70 (10.00%)  7
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/70 (1.43%)  4
Back pain  1  5/70 (7.14%)  11
Joint pain  1  3/70 (4.29%)  3
Muscle weakness  1  6/70 (8.57%)  6
Muscle weakness lower limb  1  1/70 (1.43%)  1
Myalgia  1  17/70 (24.29%)  22
Myositis  1  1/70 (1.43%)  1
Nervous system disorders   
Dizziness  1  16/70 (22.86%)  28
Headache  1  3/70 (4.29%)  4
Neurological disorder NOS  1  3/70 (4.29%)  4
Peripheral motor neuropathy  1  1/70 (1.43%)  1
Peripheral sensory neuropathy  1  22/70 (31.43%)  56
Recurrent laryngeal nerve palsy  1  1/70 (1.43%)  1
Seizure  1  1/70 (1.43%)  1
Syncope  1  1/70 (1.43%)  1
Taste alteration  1  13/70 (18.57%)  36
Tremor  1  2/70 (2.86%)  3
Psychiatric disorders   
Agitation  1  2/70 (2.86%)  3
Anxiety  1  10/70 (14.29%)  37
Confusion  1  2/70 (2.86%)  2
Depression  1  3/70 (4.29%)  8
Insomnia  1  11/70 (15.71%)  38
Renal and urinary disorders   
Hemorrhage urinary tract  1  1/70 (1.43%)  1
Protein urine positive  1  4/70 (5.71%)  4
Urinary frequency  1  1/70 (1.43%)  1
Urinary retention  1  3/70 (4.29%)  3
Reproductive system and breast disorders   
Penile pain  1  1/70 (1.43%)  1
Vaginal dryness  1  1/70 (1.43%)  2
Vaginal mucositis  1  1/70 (1.43%)  4
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/70 (1.43%)  1
Atelectasis  1  4/70 (5.71%)  4
Bronchospasm  1  1/70 (1.43%)  1
Chylothorax  1  1/70 (1.43%)  1
Cough  1  20/70 (28.57%)  41
Dyspnea  1  16/70 (22.86%)  30
Epistaxis  1  1/70 (1.43%)  2
Hemorrhage nasal  1  6/70 (8.57%)  12
Hiccough  1  1/70 (1.43%)  1
Hypoxia  1  1/70 (1.43%)  1
Nasal congestion  1  1/70 (1.43%)  1
Pharyngolaryngeal pain  1  3/70 (4.29%)  3
Pleural effusion  1  17/70 (24.29%)  17
Pneumonitis  1  3/70 (4.29%)  3
Pneumothorax  1  4/70 (5.71%)  4
Respiratory disorder  1  4/70 (5.71%)  14
Voice alteration  1  4/70 (5.71%)  4
Skin and subcutaneous tissue disorders   
Alopecia  1  19/70 (27.14%)  49
Dry skin  1  8/70 (11.43%)  22
Hand-and-foot syndrome  1  1/70 (1.43%)  1
Nail disorder  1  1/70 (1.43%)  1
Pain of skin  1  1/70 (1.43%)  1
Pruritus  1  33/70 (47.14%)  82
Rash acneiform  1  66/70 (94.29%)  279
Rash desquamating  1  26/70 (37.14%)  60
Skin disorder  1  2/70 (2.86%)  2
Skin hyperpigmentation  1  1/70 (1.43%)  1
Sweating  1  1/70 (1.43%)  1
Urticaria  1  1/70 (1.43%)  1
Vascular disorders   
Flushing  1  2/70 (2.86%)  2
Hot flashes  1  1/70 (1.43%)  3
Hypertension  1  3/70 (4.29%)  3
Hypotension  1  11/70 (15.71%)  15
Phlebitis  1  2/70 (2.86%)  3
Thrombosis  1  1/70 (1.43%)  1
Vascular disorder  1  1/70 (1.43%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. A. Craig Lockhart
Organization: Washington University School of Medicine
Phone: 314-454-8306
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00757172     History of Changes
Other Study ID Numbers: ACOSOG-Z4051
ACOSOG-Z4051
CDR0000596674 ( Registry Identifier: Physician Data Query )
NCI-2009-00346 ( Registry Identifier: NCI Clinical Trials Reporting Office )
U10CA076001 ( U.S. NIH Grant/Contract )
First Submitted: September 22, 2008
First Posted: September 23, 2008
Results First Submitted: July 25, 2014
Results First Posted: August 19, 2014
Last Update Posted: March 11, 2016