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Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00601900
Recruitment Status : Active, not recruiting
First Posted : January 28, 2008
Results First Posted : August 23, 2016
Last Update Posted : February 24, 2020
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 Invasive Breast Carcinoma
Recurrent Breast Carcinoma
Stage III Breast Cancer AJCC v6
Stage IV Breast Cancer AJCC v6 and v7
Interventions Biological: Bevacizumab
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Other: Questionnaire Administration
Drug: Tamoxifen Citrate
Enrollment 394
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Endocrine Therapy With Monoclonal Antibody) Arm II (Endocrine Therapy)
Hide Arm/Group Description Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 195 199
Completed 195 196
Not Completed 0 3
Reason Not Completed
Withdrawal by Subject             0             3
Arm/Group Title Arm I (Endocrine Therapy With Monoclonal Antibody) Arm II (Endocrine Therapy) Total
Hide Arm/Group Description Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 195 196 391
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 195 participants 196 participants 391 participants
55.5
(24.7 to 85.3)
58.9
(29.0 to 87)
57.7
(24.7 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 196 participants 391 participants
Female
195
 100.0%
196
 100.0%
391
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 195 participants 196 participants 391 participants
195 196 391
Endocrine Therapy Elected  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 195 participants 196 participants 391 participants
Letrozole 174 174 348
Tamoxifen 21 22 43
1.Primary Outcome
Title Progression-free Survival
Hide Description The Primary Endpoint for this study was to compare the progression-free survival of letrozole therapy alone with the combination of letrozole therapy plus bevacizumab as first-line treatment in women with estrogen- and/or progesterone-receptor-positive advanced breast cancer. Progression-free survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions from baseline or the appearance of new lesions.
Time Frame From randomization until disease progression or death whichever occurs first, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.
Arm/Group Title Arm I (Endocrine Therapy With Monoclonal Antibody) Arm II (Endocrine Therapy)
Hide Arm/Group Description:
Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 173 170
Median (95% Confidence Interval)
Unit of Measure: months
20.2
(17 to 24)
15.6
(12.9 to 19.7)
2.Secondary Outcome
Title 12 Month Progression Free Survival Rate
Hide Description The 12 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 12 months after registration into the study.
Time Frame At 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.
Arm/Group Title Arm I (Endocrine Therapy With Monoclonal Antibody) Arm II (Endocrine Therapy)
Hide Arm/Group Description:
Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 173 170
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73
(66 to 80)
61
(54 to 68)
3.Secondary Outcome
Title 6 Month Progression-Free Survival Rate
Hide Description The 6 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 6 months after registration into the study.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.
Arm/Group Title Arm I (Endocrine Therapy With Monoclonal Antibody) Arm II (Endocrine Therapy)
Hide Arm/Group Description:
Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 173 170
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87
(82 to 93)
77
(71 to 83)
4.Secondary Outcome
Title Objective Response Rate
Hide Description Response was defined using RECIST criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.
Time Frame Assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the analysis of this endpoint was restricted to patients that elected letrozole as endocrine therapy and began treatment with measureable disease. A total of 213 patients (Arm A:106; Arm B:107) had measureable disease. Of the 213, 197 (Arm A:98, Arm B:99) patients were assessed for response during treatment.
Arm/Group Title Arm I (Endocrine Therapy With Monoclonal Antibody) Arm II (Endocrine Therapy)
Hide Arm/Group Description:
Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 98 99
Measure Type: Number
Unit of Measure: percentage of participants
Complete Response (CR) 4 7
Partial Response (PR) 65 42
Stable Disease (SD) 22 34
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.
Time Frame Assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.
Arm/Group Title Arm I (Endocrine Therapy With Monoclonal Antibody) Arm II (Endocrine Therapy)
Hide Arm/Group Description:
Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 173 170
Median (95% Confidence Interval)
Unit of Measure: months
47.2
(39 to 56.8)
43.9
(37.6 to 49.6)
6.Secondary Outcome
Title Duration of Tumor Response
Hide Description Defined by RECIST criteria.
Time Frame From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Probability of Surviving Until 36 Months
Hide Description [Not Specified]
Time Frame At 36 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Site of Progression
Hide Description [Not Specified]
Time Frame Up to 5 years
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Time-to-treatment Failure
Hide Description From randomization until first disease progression, early termination of protocol therapy due to toxicity or withdrawn consent, or going onto non-protocol therapy. Defined by RECIST criteria. The proportional hazards model will be used to compare the arms on time-to-treatment-failure
Time Frame Up to 5 years
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Treatment Related Toxicity
Hide Description Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Tabulated by type, grade, and arm.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
Time Frame All patients that received study treatment and were analyzed for adverse events are included in this summary.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Endocrine Therapy With Monoclonal Antibody) Arm II (Endocrine Therapy)
Hide Arm/Group Description Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm I (Endocrine Therapy With Monoclonal Antibody) Arm II (Endocrine Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm I (Endocrine Therapy With Monoclonal Antibody) Arm II (Endocrine Therapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/195 (28.72%)      30/196 (15.31%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Cardiac disorders     
Cardiac valve disease  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Cardiopulmonary arrest  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Left ventricular failure  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Myocardial ischemia  1  1/195 (0.51%)  1 1/196 (0.51%)  1
Pericardial effusion  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Abdominal pain  1  3/195 (1.54%)  3 1/196 (0.51%)  1
Colitis  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Constipation  1  1/195 (0.51%)  1 1/196 (0.51%)  1
Diarrhea  1  3/195 (1.54%)  3 0/196 (0.00%)  0
Enteritis  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Gastric hemorrhage  1  1/195 (0.51%)  1 1/196 (0.51%)  1
Gastritis  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Ileus  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Nausea  1  8/195 (4.10%)  8 1/196 (0.51%)  1
Pancreatitis  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Rectal hemorrhage  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Small intestinal obstruction  1  1/195 (0.51%)  2 0/196 (0.00%)  0
Upper gastrointestinal hemorrhage  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Vomiting  1  5/195 (2.56%)  5 1/196 (0.51%)  1
General disorders     
Chest pain  1  2/195 (1.03%)  2 1/196 (0.51%)  1
Death NOS  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Disease progression  1  0/195 (0.00%)  0 3/196 (1.53%)  3
Edema limbs  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Fatigue  1  3/195 (1.54%)  3 1/196 (0.51%)  1
Fever  1  6/195 (3.08%)  6 2/196 (1.02%)  2
Sudden death  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Hepatic pain  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Hepatobiliary disease  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Infections and infestations     
Appendicitis  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Appendicitis perforated  1  0/195 (0.00%)  0 2/196 (1.02%)  2
Endocarditis infective  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Eye infection  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Infection  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Infection without neutropenia  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Pneumonia  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Sepsis  1  0/195 (0.00%)  0 2/196 (1.02%)  2
Sinusitis  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Skin infection  1  2/195 (1.03%)  2 2/196 (1.02%)  2
Tooth infection  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Urinary tract infection  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Wound infection  1  3/195 (1.54%)  3 0/196 (0.00%)  0
Injury, poisoning and procedural complications     
Fracture  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Intraoperative reproductive tract injury - Uterus  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Small intestinal anastomotic leak  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Wound dehiscence  1  1/195 (0.51%)  1 1/196 (0.51%)  1
Investigations     
Alanine aminotransferase increased  1  1/195 (0.51%)  1 1/196 (0.51%)  1
Alkaline phosphatase increased  1  3/195 (1.54%)  3 0/196 (0.00%)  0
Aspartate aminotransferase increased  1  3/195 (1.54%)  3 1/196 (0.51%)  1
Blood bilirubin increased  1  2/195 (1.03%)  2 1/196 (0.51%)  1
Cardiac troponin T increased  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Creatinine increased  1  2/195 (1.03%)  2 0/196 (0.00%)  0
INR increased  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Leukocyte count decreased  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Lymphocyte count decreased  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Neutrophil count decreased  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Platelet count decreased  1  1/195 (0.51%)  1 1/196 (0.51%)  1
Metabolism and nutrition disorders     
Acidosis  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Anorexia  1  4/195 (2.05%)  4 1/196 (0.51%)  1
Blood glucose increased  1  0/195 (0.00%)  0 1/196 (0.51%)  2
Dehydration  1  4/195 (2.05%)  4 1/196 (0.51%)  1
Serum albumin decreased  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Serum calcium decreased  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Serum phosphate decreased  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Serum potassium decreased  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Serum potassium increased  1  1/195 (0.51%)  1 1/196 (0.51%)  1
Serum sodium decreased  1  3/195 (1.54%)  3 1/196 (0.51%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  24/195 (12.31%)  31 12/196 (6.12%)  18
Muscle weakness  1  3/195 (1.54%)  3 0/196 (0.00%)  0
Myalgia  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Osteonecrosis  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Osteoporosis  1  1/195 (0.51%)  2 0/196 (0.00%)  0
Nervous system disorders     
Depressed level of consciousness  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Headache  1  13/195 (6.67%)  15 4/196 (2.04%)  5
Intracranial hemorrhage  1  1/195 (0.51%)  1 1/196 (0.51%)  1
Ischemia cerebrovascular  1  2/195 (1.03%)  2 1/196 (0.51%)  1
Leukoencephalopathy  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Memory impairment  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Neuralgia  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Neurological disorder NOS  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Peripheral sensory neuropathy  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Seizure  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Speech disorder  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Syncope  1  3/195 (1.54%)  3 1/196 (0.51%)  1
Psychiatric disorders     
Confusion  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Depression  1  2/195 (1.03%)  2 1/196 (0.51%)  2
Renal and urinary disorders     
Proteinuria  1  18/195 (9.23%)  21 2/196 (1.02%)  3
Renal failure  1  3/195 (1.54%)  3 0/196 (0.00%)  0
Reproductive system and breast disorders     
Vaginal hemorrhage  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Respiratory, thoracic and mediastinal disorders     
Apnea  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Atelectasis  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Dyspnea  1  5/195 (2.56%)  5 2/196 (1.02%)  2
Epistaxis  1  2/195 (1.03%)  3 0/196 (0.00%)  0
Hypoxia  1  3/195 (1.54%)  3 1/196 (0.51%)  1
Pleural effusion  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Pneumonitis  1  1/195 (0.51%)  1 1/196 (0.51%)  1
Pneumothorax  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Respiratory disorder  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Vascular disorders     
Hypertension  1  20/195 (10.26%)  23 6/196 (3.06%)  6
Hypotension  1  2/195 (1.03%)  2 1/196 (0.51%)  1
Thrombosis  1  0/195 (0.00%)  0 3/196 (1.53%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Endocrine Therapy With Monoclonal Antibody) Arm II (Endocrine Therapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   174/195 (89.23%)      145/196 (73.98%)    
Blood and lymphatic system disorders     
Blood disorder  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Hemoglobin decreased  1  5/195 (2.56%)  12 2/196 (1.02%)  2
Hemolysis  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  1/195 (0.51%)  16 0/196 (0.00%)  0
Cardiac valve disease  1  0/195 (0.00%)  0 1/196 (0.51%)  2
Left ventricular failure  1  4/195 (2.05%)  4 0/196 (0.00%)  0
Myocardial ischemia  1  1/195 (0.51%)  1 2/196 (1.02%)  4
Palpitations  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Eye disorders     
Cataract  1  0/195 (0.00%)  0 2/196 (1.02%)  4
Dry eye syndrome  1  1/195 (0.51%)  17 0/196 (0.00%)  0
Vision blurred  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  3/195 (1.54%)  6 0/196 (0.00%)  0
Anal hemorrhage  1  2/195 (1.03%)  5 0/196 (0.00%)  0
Anal pain  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Colitis  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Colonic hemorrhage  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Constipation  1  2/195 (1.03%)  3 2/196 (1.02%)  2
Diarrhea  1  4/195 (2.05%)  29 0/196 (0.00%)  0
Dyspepsia  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Esophageal pain  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Esophagitis  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Gastric ulcer  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Gastritis  1  1/195 (0.51%)  20 0/196 (0.00%)  0
Gastrointestinal disorder  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Hemorrhoidal hemorrhage  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Hemorrhoids  1  0/195 (0.00%)  0 1/196 (0.51%)  2
Mouth necrosis  1  1/195 (0.51%)  3 0/196 (0.00%)  0
Nausea  1  5/195 (2.56%)  19 1/196 (0.51%)  1
Oral hemorrhage  1  2/195 (1.03%)  5 1/196 (0.51%)  1
Rectal hemorrhage  1  2/195 (1.03%)  2 2/196 (1.02%)  2
Toothache  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Upper gastrointestinal hemorrhage  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Vomiting  1  1/195 (0.51%)  1 0/196 (0.00%)  0
General disorders     
Chest pain  1  2/195 (1.03%)  3 1/196 (0.51%)  1
Chills  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Edema limbs  1  3/195 (1.54%)  5 0/196 (0.00%)  0
Fatigue  1  19/195 (9.74%)  69 12/196 (6.12%)  21
Fever  1  24/195 (12.31%)  32 15/196 (7.65%)  18
Flu-like symptoms  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Localized edema  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Pain  1  4/195 (2.05%)  15 1/196 (0.51%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Hepatic pain  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  13/195 (6.67%)  27 2/196 (1.02%)  2
Infections and infestations     
Appendicitis  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Bladder infection  1  0/195 (0.00%)  0 2/196 (1.02%)  2
Bronchitis  1  2/195 (1.03%)  2 2/196 (1.02%)  3
Catheter related infection  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Conjunctivitis infective  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Endocarditis infective  1  0/195 (0.00%)  0 1/196 (0.51%)  2
Eye infection  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Gingival infection  1  1/195 (0.51%)  2 1/196 (0.51%)  1
Infection  1  3/195 (1.54%)  3 1/196 (0.51%)  1
Infectious colitis  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Lip infection  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Otitis externa  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Pharyngitis  1  1/195 (0.51%)  4 0/196 (0.00%)  0
Pneumonia  1  0/195 (0.00%)  0 3/196 (1.53%)  3
Sinusitis  1  7/195 (3.59%)  25 3/196 (1.53%)  4
Skin infection  1  2/195 (1.03%)  3 1/196 (0.51%)  1
Tooth infection  1  4/195 (2.05%)  6 0/196 (0.00%)  0
Upper aerodigestive tract infection  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Upper respiratory infection  1  10/195 (5.13%)  14 5/196 (2.55%)  11
Ureteritis  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Urinary tract infection  1  10/195 (5.13%)  16 4/196 (2.04%)  5
Vaginal infection  1  1/195 (0.51%)  1 2/196 (1.02%)  4
Vulvitis  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Wound infection  1  1/195 (0.51%)  6 0/196 (0.00%)  0
Injury, poisoning and procedural complications     
Fracture  1  0/195 (0.00%)  0 2/196 (1.02%)  2
Wound dehiscence  1  6/195 (3.08%)  8 1/196 (0.51%)  2
Investigations     
Alanine aminotransferase increased  1  4/195 (2.05%)  8 2/196 (1.02%)  6
Alkaline phosphatase increased  1  4/195 (2.05%)  9 1/196 (0.51%)  1
Aspartate aminotransferase increased  1  7/195 (3.59%)  14 3/196 (1.53%)  5
Blood bilirubin increased  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Creatinine increased  1  3/195 (1.54%)  7 1/196 (0.51%)  2
Gamma-glutamyltransferase increased  1  2/195 (1.03%)  3 0/196 (0.00%)  0
INR increased  1  2/195 (1.03%)  10 0/196 (0.00%)  0
Leukocyte count decreased  1  1/195 (0.51%)  12 1/196 (0.51%)  1
Lymphocyte count decreased  1  2/195 (1.03%)  3 0/196 (0.00%)  0
Neutrophil count decreased  1  2/195 (1.03%)  14 1/196 (0.51%)  1
Platelet count decreased  1  3/195 (1.54%)  28 0/196 (0.00%)  0
Weight loss  1  5/195 (2.56%)  39 1/196 (0.51%)  2
Metabolism and nutrition disorders     
Anorexia  1  2/195 (1.03%)  22 0/196 (0.00%)  0
Blood glucose increased  1  4/195 (2.05%)  26 4/196 (2.04%)  8
Dehydration  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Glucose intolerance  1  1/195 (0.51%)  4 0/196 (0.00%)  0
Obesity  1  0/195 (0.00%)  0 1/196 (0.51%)  4
Serum calcium decreased  1  4/195 (2.05%)  5 0/196 (0.00%)  0
Serum calcium increased  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Serum glucose decreased  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Serum magnesium decreased  1  1/195 (0.51%)  2 0/196 (0.00%)  0
Serum phosphate decreased  1  1/195 (0.51%)  3 0/196 (0.00%)  0
Serum potassium decreased  1  2/195 (1.03%)  3 2/196 (1.02%)  2
Serum potassium increased  1  3/195 (1.54%)  3 0/196 (0.00%)  0
Serum sodium decreased  1  4/195 (2.05%)  8 2/196 (1.02%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  137/195 (70.26%)  1597 115/196 (58.67%)  1120
Back pain  1  13/195 (6.67%)  37 7/196 (3.57%)  23
Bone pain  1  10/195 (5.13%)  16 2/196 (1.02%)  3
Chest wall pain  1  0/195 (0.00%)  0 2/196 (1.02%)  2
Muscle weakness  1  0/195 (0.00%)  0 2/196 (1.02%)  2
Muscle weakness lower limb  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Myalgia  1  7/195 (3.59%)  14 6/196 (3.06%)  19
Neck pain  1  1/195 (0.51%)  3 3/196 (1.53%)  6
Osteonecrosis  1  2/195 (1.03%)  5 0/196 (0.00%)  0
Osteoporosis  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Pain in extremity  1  6/195 (3.08%)  12 2/196 (1.02%)  15
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Treatment related secondary malignancy  1  0/195 (0.00%)  0 2/196 (1.02%)  2
Nervous system disorders     
Acoustic nerve disorder NOS  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Dizziness  1  4/195 (2.05%)  5 2/196 (1.02%)  2
Headache  1  85/195 (43.59%)  409 58/196 (29.59%)  245
Ischemia cerebrovascular  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Memory impairment  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Neuralgia  1  3/195 (1.54%)  7 0/196 (0.00%)  0
Neurological disorder NOS  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Peripheral sensory neuropathy  1  4/195 (2.05%)  4 2/196 (1.02%)  5
Syncope  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Tremor  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Psychiatric disorders     
Anxiety  1  4/195 (2.05%)  6 3/196 (1.53%)  4
Confusion  1  1/195 (0.51%)  1 1/196 (0.51%)  1
Depression  1  5/195 (2.56%)  24 2/196 (1.02%)  3
Insomnia  1  3/195 (1.54%)  3 3/196 (1.53%)  3
Personality change  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Renal and urinary disorders     
Proteinuria  1  93/195 (47.69%)  818 13/196 (6.63%)  42
Renal failure  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Urinary frequency  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Reproductive system and breast disorders     
Breast pain  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Irregular menstruation  1  0/195 (0.00%)  0 1/196 (0.51%)  2
Pelvic pain  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Vaginal dryness  1  1/195 (0.51%)  1 1/196 (0.51%)  6
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  3/195 (1.54%)  16 2/196 (1.02%)  2
Bronchopulmonary hemorrhage  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Cough  1  3/195 (1.54%)  3 1/196 (0.51%)  1
Dyspnea  1  3/195 (1.54%)  3 5/196 (2.55%)  5
Epistaxis  1  24/195 (12.31%)  160 2/196 (1.02%)  5
Hypoxia  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Pleural effusion  1  1/195 (0.51%)  4 1/196 (0.51%)  1
Pneumothorax  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Respiratory disorder  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Voice alteration  1  2/195 (1.03%)  2 0/196 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  1/195 (0.51%)  1 1/196 (0.51%)  1
Pruritus  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Rash desquamating  1  1/195 (0.51%)  2 0/196 (0.00%)  0
Skin disorder  1  1/195 (0.51%)  1 0/196 (0.00%)  0
Skin ulceration  1  1/195 (0.51%)  7 0/196 (0.00%)  0
Vascular disorders     
Hemorrhage  1  3/195 (1.54%)  4 0/196 (0.00%)  0
Hot flashes  1  12/195 (6.15%)  46 8/196 (4.08%)  34
Hypertension  1  115/195 (58.97%)  1029 61/196 (31.12%)  528
Hypotension  1  0/195 (0.00%)  0 1/196 (0.51%)  1
Thrombosis  1  6/195 (3.08%)  7 2/196 (1.02%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Maura Dickler, M.D.
Organization: Memorial Sloan-Kettering Cancer Center
EMail: dicklerm@mskcc.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00601900    
Other Study ID Numbers: NCI-2009-00477
NCI-2009-00477 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CALGB-40503
CDR0000584091
CALGB 40503/CTSU 40503
CALGB-40503 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-40503 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: January 18, 2008
First Posted: January 28, 2008
Results First Submitted: May 16, 2016
Results First Posted: August 23, 2016
Last Update Posted: February 24, 2020