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Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT00770809
Recruitment Status : Active, not recruiting
First Posted : October 10, 2008
Results First Posted : May 27, 2015
Last Update Posted : January 3, 2023
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 Male Breast Carcinoma
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Stage IIIA Breast Cancer AJCC v7
Stage IIIB Breast Cancer AJCC v7
Stage IIIC Breast Cancer AJCC v7
Interventions Other: Laboratory Biomarker Analysis
Drug: Lapatinib Ditosylate
Drug: Paclitaxel
Biological: Trastuzumab
Enrollment 305
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (THL) Arm II (TH) Arm III (TL)
Hide Arm/Group Description Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
Period Title: Overall Study
Started 118 120 67
Completed 101 110 44
Not Completed 17 10 23
Reason Not Completed
Adverse Event             9             1             12
Death             1             0             0
Withdrawal by Subject             3             3             7
Progression             2             2             0
Complicating illness             0             0             1
Other Medical Reasons             2             4             3
Arm/Group Title Arm I (THL) Arm II (TH) Arm III (TL) Total
Hide Arm/Group Description Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11) Total of all reporting groups
Overall Number of Baseline Participants 118 120 67 305
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 118 participants 120 participants 67 participants 305 participants
48.5
(24.7 to 70.8)
50.3
(30.2 to 75.8)
48.3
(25.8 to 74.3)
49.4
(24.7 to 75.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 120 participants 67 participants 305 participants
Female
117
  99.2%
119
  99.2%
67
 100.0%
303
  99.3%
Male
1
   0.8%
1
   0.8%
0
   0.0%
2
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 120 participants 67 participants 305 participants
American Indian or Alaska Native
1
   0.8%
1
   0.8%
0
   0.0%
2
   0.7%
Asian
4
   3.4%
8
   6.7%
5
   7.5%
17
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.8%
0
   0.0%
1
   0.3%
Black or African American
12
  10.2%
8
   6.7%
7
  10.4%
27
   8.9%
White
95
  80.5%
97
  80.8%
51
  76.1%
243
  79.7%
More than one race
2
   1.7%
0
   0.0%
0
   0.0%
2
   0.7%
Unknown or Not Reported
4
   3.4%
5
   4.2%
4
   6.0%
13
   4.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 118 participants 120 participants 67 participants 305 participants
118 120 67 305
Clinical Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 118 participants 120 participants 67 participants 305 participants
Stage II 81 80 48 209
Stage III 37 40 19 96
[1]
Measure Description: The American Joint Committee on Cancer (AJCC) has designated staging by tumor, node, and metastasis (TNM) classification. Stage II participants had primary tumors 0-5 cm and no regional lymph node metastases or metastases to movable ipsilateral level I, II axillary lymph node or primary tumors > 5.1 cm and no regional lymph node metastases. Stage III participants had primary tumors of any size but not any metastases in ipsilateral infraclavicular (level III axillary) lymph node(s) with or without level I, II axillary lymph node involvement
Hormone Receptor Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 118 participants 120 participants 67 participants 305 participants
ER/PgR Positive 70 70 39 179
ER/PgR or Negative 48 50 28 126
1.Primary Outcome
Title pCR Rate
Hide Description Complete pathological response is defined as the absence of residual invasive carcinoma in the breast at the time of definitive surgical removal. Pathologic complete response in the lymph nodes is defined as no detectable invasive tumor by H&E. Analysis will use a chi-square test for the difference in proportions of patients on the THL arm versus the TH arm who achieve a pCR. Exact binomial methods will be used to construct 95% confidence intervals around the pCR incidence for each arm.
Time Frame At time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who did not start protocol therapy or withdrew prior to surgery are excluded. Participants who did not undergo surgery are considered no having a pCR.
Arm/Group Title Arm I (THL) Arm II (TH) Arm III (TL)
Hide Arm/Group Description:
Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
Overall Number of Participants Analyzed 116 117 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56
(47 to 65)
46
(35 to 55)
32
(22 to 45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (THL), Arm II (TH)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm II (TH), Arm III (TL)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Pathologic Stage in the Breast and Axilla
Hide Description Stage will be determined by the American Joint Committee on Cancer (AJCC) TNM (tumor, lymph nodes, metastasis) staging system.
Time Frame At time of surgery
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Radiographic Response Rate (at Completion of Neoadjuvant Therapy)
Hide Description Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions).
Time Frame Week 16
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method
Time Frame Time from randomization to death or last follow-up (up to 10 years)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Relapse-free Survival (RFS)
Hide Description Relapse free survival is defined as the interval from definitive surgery to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, or death from any cause, whichever occurs first. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Patients who do not undergo definitive surgery will not be assessable for RFS. Distribution was estimated using the Kaplan Meier product-limit method.
Time Frame Time from surgery to any recurrence (up to 10 years)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time to First Failure
Hide Description Time to first failure is defined as the interval from study entry to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence or death from any cause. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Distribution was estimated using the Kaplan Meier product-limit method.
Time Frame Time from study entry to any recurrence ( up to 10 years)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3
Hide Description The type and grade of treatment-related toxicity will be tabulated by treatment arm.
Time Frame Up to 30 days post-treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Event data is available on 295 participants (Arm I: 115. Arm II: 115, Arm III: 65)
 
Arm/Group Title Arm I (THL) Arm II (TH) Arm III (TL)
Hide Arm/Group Description Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
All-Cause Mortality
Arm I (THL) Arm II (TH) Arm III (TL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Arm I (THL) Arm II (TH) Arm III (TL)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/115 (13.04%)      12/115 (10.43%)      6/65 (9.23%)    
Blood and lymphatic system disorders       
Febrile neutropenia  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Hemoglobin decreased  1  9/115 (7.83%)  11 7/115 (6.09%)  8 4/65 (6.15%)  5
Cardiac disorders       
Cardiopulmonary arrest  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Pericarditis  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Gastrointestinal disorders       
Abdominal pain  1  1/115 (0.87%)  1 1/115 (0.87%)  1 0/65 (0.00%)  0
Constipation  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Diarrhea  1  12/115 (10.43%)  16 5/115 (4.35%)  5 5/65 (7.69%)  6
Nausea  1  7/115 (6.09%)  9 2/115 (1.74%)  3 2/65 (3.08%)  2
Pancreatitis  1  1/115 (0.87%)  1 0/115 (0.00%)  0 1/65 (1.54%)  1
Vomiting  1  3/115 (2.61%)  3 1/115 (0.87%)  1 1/65 (1.54%)  1
General disorders       
Edema limbs  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Fatigue  1  11/115 (9.57%)  15 8/115 (6.96%)  9 4/65 (6.15%)  4
Immune system disorders       
Hypersensitivity  1  1/115 (0.87%)  1 1/115 (0.87%)  1 0/65 (0.00%)  0
Infections and infestations       
Gallbladder infection  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Infection  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Pneumonia  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Sepsis  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Skin infection  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Soft tissue infection  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Urinary tract infection  1  2/115 (1.74%)  4 0/115 (0.00%)  0 0/65 (0.00%)  0
Injury, poisoning and procedural complications       
Seroma  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  1/115 (0.87%)  2 2/115 (1.74%)  2 3/65 (4.62%)  3
Amylase increased  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Aspartate aminotransferase increased  1  2/115 (1.74%)  3 1/115 (0.87%)  1 2/65 (3.08%)  2
Leukocyte count decreased  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Lipase increased  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Neutrophil count decreased  1  5/115 (4.35%)  6 3/115 (2.61%)  4 2/65 (3.08%)  2
Metabolism and nutrition disorders       
Dehydration  1  0/115 (0.00%)  0 1/115 (0.87%)  1 1/65 (1.54%)  1
Serum potassium decreased  1  3/115 (2.61%)  3 0/115 (0.00%)  0 1/65 (1.54%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Bone pain  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Chest wall pain  1  1/115 (0.87%)  2 0/115 (0.00%)  0 1/65 (1.54%)  1
Myalgia  1  3/115 (2.61%)  3 2/115 (1.74%)  3 0/65 (0.00%)  0
Nervous system disorders       
Headache  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Peripheral sensory neuropathy  1  6/115 (5.22%)  7 4/115 (3.48%)  4 1/65 (1.54%)  1
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia  1  1/115 (0.87%)  2 0/115 (0.00%)  0 0/65 (0.00%)  0
Rash desquamating  1  5/115 (4.35%)  7 2/115 (1.74%)  3 4/65 (6.15%)  4
Vascular disorders       
Hypertension  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Hypotension  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Thrombosis  1  1/115 (0.87%)  2 0/115 (0.00%)  0 0/65 (0.00%)  0
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 (THL) Arm II (TH) Arm III (TL)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   114/115 (99.13%)      114/115 (99.13%)      64/65 (98.46%)    
Blood and lymphatic system disorders       
Blood disorder  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Febrile neutropenia  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Hemoglobin decreased  1  74/115 (64.35%)  232 72/115 (62.61%)  218 40/65 (61.54%)  114
Hemolysis  1  1/115 (0.87%)  4 0/115 (0.00%)  0 1/65 (1.54%)  1
Cardiac disorders       
Cardiac disorder  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Left ventricular failure  1  4/115 (3.48%)  5 4/115 (3.48%)  5 0/65 (0.00%)  0
Myocardial ischemia  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Sinus bradycardia  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Sinus tachycardia  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Ear and labyrinth disorders       
Tinnitus  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Eye disorders       
Dry eye syndrome  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Eye disorder  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Vision blurred  1  2/115 (1.74%)  2 1/115 (0.87%)  1 1/65 (1.54%)  1
Watering eyes  1  0/115 (0.00%)  0 1/115 (0.87%)  3 0/65 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension  1  0/115 (0.00%)  0 1/115 (0.87%)  2 0/65 (0.00%)  0
Abdominal pain  1  1/115 (0.87%)  3 2/115 (1.74%)  2 1/65 (1.54%)  2
Constipation  1  1/115 (0.87%)  1 6/115 (5.22%)  10 0/65 (0.00%)  0
Diarrhea  1  100/115 (86.96%)  307 55/115 (47.83%)  110 56/65 (86.15%)  148
Dyspepsia  1  3/115 (2.61%)  5 4/115 (3.48%)  9 2/65 (3.08%)  2
Ear, nose and throat examination abnormal  1  0/115 (0.00%)  0 1/115 (0.87%)  1 1/65 (1.54%)  1
Flatulence  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Hemorrhoids  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Mucositis oral  1  2/115 (1.74%)  2 3/115 (2.61%)  4 2/65 (3.08%)  2
Nausea  1  61/115 (53.04%)  136 45/115 (39.13%)  94 32/65 (49.23%)  66
Oral hemorrhage  1  2/115 (1.74%)  2 0/115 (0.00%)  0 0/65 (0.00%)  0
Toothache  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Vomiting  1  18/115 (15.65%)  28 13/115 (11.30%)  14 16/65 (24.62%)  23
General disorders       
Chills  1  0/115 (0.00%)  0 0/115 (0.00%)  0 2/65 (3.08%)  3
Edema limbs  1  4/115 (3.48%)  5 6/115 (5.22%)  7 1/65 (1.54%)  2
Fatigue  1  101/115 (87.83%)  313 97/115 (84.35%)  319 47/65 (72.31%)  140
Fever  1  2/115 (1.74%)  2 1/115 (0.87%)  1 0/65 (0.00%)  0
General symptom  1  0/115 (0.00%)  0 1/115 (0.87%)  1 1/65 (1.54%)  1
Localized edema  1  1/115 (0.87%)  1 1/115 (0.87%)  1 0/65 (0.00%)  0
Pain  1  0/115 (0.00%)  0 2/115 (1.74%)  2 3/65 (4.62%)  6
Hepatobiliary disorders       
Hepatobiliary disease  1  0/115 (0.00%)  0 1/115 (0.87%)  3 0/65 (0.00%)  0
Immune system disorders       
Hypersensitivity  1  11/115 (9.57%)  16 14/115 (12.17%)  18 8/65 (12.31%)  9
Infections and infestations       
Biliary tract infection  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Bladder infection  1  1/115 (0.87%)  1 0/115 (0.00%)  0 1/65 (1.54%)  1
Catheter related infection  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Colitis, infectious (e.g., Clostridium difficile)  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Device related infection  1  1/115 (0.87%)  1 2/115 (1.74%)  2 0/65 (0.00%)  0
Infection  1  1/115 (0.87%)  1 2/115 (1.74%)  3 1/65 (1.54%)  1
Mucosal infection  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Nail infection  1  0/115 (0.00%)  0 0/115 (0.00%)  0 2/65 (3.08%)  2
Pharyngitis  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Pneumonia  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Sinusitis  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Skin infection  1  0/115 (0.00%)  0 2/115 (1.74%)  2 0/65 (0.00%)  0
Upper respiratory infection  1  2/115 (1.74%)  2 1/115 (0.87%)  1 1/65 (1.54%)  1
Urinary tract infection  1  1/115 (0.87%)  1 0/115 (0.00%)  0 1/65 (1.54%)  1
Vaginal infection  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Wound infection  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Injury, poisoning and procedural complications       
Fracture  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Intraoperative hepatobiliary injury  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Vascular access complication  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Wound dehiscence  1  1/115 (0.87%)  1 1/115 (0.87%)  2 0/65 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  15/115 (13.04%)  26 9/115 (7.83%)  19 6/65 (9.23%)  6
Alkaline phosphatase increased  1  2/115 (1.74%)  4 0/115 (0.00%)  0 1/65 (1.54%)  1
Amylase increased  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Aspartate aminotransferase increased  1  12/115 (10.43%)  20 8/115 (6.96%)  14 4/65 (6.15%)  4
Blood bilirubin increased  1  2/115 (1.74%)  3 0/115 (0.00%)  0 0/65 (0.00%)  0
CD4 lymphocytes decreased  1  1/115 (0.87%)  1 1/115 (0.87%)  1 0/65 (0.00%)  0
Leukocyte count decreased  1  7/115 (6.09%)  11 6/115 (5.22%)  10 4/65 (6.15%)  7
Lymphocyte count decreased  1  1/115 (0.87%)  1 1/115 (0.87%)  2 0/65 (0.00%)  0
Neutrophil count decreased  1  41/115 (35.65%)  60 29/115 (25.22%)  51 19/65 (29.23%)  40
Platelet count decreased  1  2/115 (1.74%)  4 2/115 (1.74%)  4 3/65 (4.62%)  3
Weight gain  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  1  2/115 (1.74%)  3 3/115 (2.61%)  6 1/65 (1.54%)  1
Blood glucose increased  1  2/115 (1.74%)  5 4/115 (3.48%)  11 2/65 (3.08%)  6
Dehydration  1  2/115 (1.74%)  3 0/115 (0.00%)  0 0/65 (0.00%)  0
Serum albumin decreased  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Serum calcium decreased  1  1/115 (0.87%)  3 0/115 (0.00%)  0 0/65 (0.00%)  0
Serum calcium increased  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Serum potassium decreased  1  8/115 (6.96%)  11 0/115 (0.00%)  0 4/65 (6.15%)  5
Serum potassium increased  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Serum sodium decreased  1  0/115 (0.00%)  0 1/115 (0.87%)  1 2/65 (3.08%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/115 (0.87%)  1 1/115 (0.87%)  1 1/65 (1.54%)  3
Arthritis  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Back pain  1  0/115 (0.00%)  0 1/115 (0.87%)  1 1/65 (1.54%)  1
Chest wall pain  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Myalgia  1  28/115 (24.35%)  49 34/115 (29.57%)  75 22/65 (33.85%)  38
Neck pain  1  1/115 (0.87%)  2 0/115 (0.00%)  0 0/65 (0.00%)  0
Nervous system disorders       
Dizziness  1  0/115 (0.00%)  0 3/115 (2.61%)  3 1/65 (1.54%)  1
Dysgeusia  1  2/115 (1.74%)  2 1/115 (0.87%)  1 0/65 (0.00%)  0
Headache  1  4/115 (3.48%)  5 4/115 (3.48%)  8 1/65 (1.54%)  1
Peripheral motor neuropathy  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Peripheral sensory neuropathy  1  92/115 (80.00%)  229 84/115 (73.04%)  198 44/65 (67.69%)  125
Seizure  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Sinus pain  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Syncope  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Tremor  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Psychiatric disorders       
Anxiety  1  1/115 (0.87%)  1 2/115 (1.74%)  4 1/65 (1.54%)  3
Depression  1  1/115 (0.87%)  2 1/115 (0.87%)  2 1/65 (1.54%)  1
Insomnia  1  6/115 (5.22%)  8 4/115 (3.48%)  7 3/65 (4.62%)  3
Libido decreased  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Renal and urinary disorders       
Hemorrhage urinary tract  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Urinary frequency  1  2/115 (1.74%)  2 1/115 (0.87%)  1 1/65 (1.54%)  1
Urinary incontinence  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Urine discoloration  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  1
Reproductive system and breast disorders       
Breast pain  1  1/115 (0.87%)  1 0/115 (0.00%)  0 2/65 (3.08%)  6
Irregular menstruation  1  2/115 (1.74%)  4 0/115 (0.00%)  0 0/65 (0.00%)  0
Vaginal discharge  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Vaginal dryness  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Vaginal pain  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  1/115 (0.87%)  1 1/115 (0.87%)  1 1/65 (1.54%)  3
Cough  1  2/115 (1.74%)  2 2/115 (1.74%)  2 2/65 (3.08%)  3
Dyspnea  1  2/115 (1.74%)  2 3/115 (2.61%)  4 2/65 (3.08%)  3
Epistaxis  1  3/115 (2.61%)  3 6/115 (5.22%)  8 4/65 (6.15%)  7
Laryngeal mucositis  1  1/115 (0.87%)  2 0/115 (0.00%)  0 0/65 (0.00%)  0
Nasal congestion  1  1/115 (0.87%)  1 1/115 (0.87%)  1 1/65 (1.54%)  1
Pharyngolaryngeal pain  1  2/115 (1.74%)  2 1/115 (0.87%)  1 0/65 (0.00%)  0
Respiratory tract hemorrhage  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Voice alteration  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  3
Skin and subcutaneous tissue disorders       
Alopecia  1  6/115 (5.22%)  9 10/115 (8.70%)  23 1/65 (1.54%)  3
Dry skin  1  3/115 (2.61%)  3 2/115 (1.74%)  2 1/65 (1.54%)  1
Erythema multiforme  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  2
Hand-and-foot syndrome  1  1/115 (0.87%)  2 1/115 (0.87%)  1 0/65 (0.00%)  0
Nail disorder  1  5/115 (4.35%)  5 10/115 (8.70%)  10 4/65 (6.15%)  7
Pain of skin  1  1/115 (0.87%)  3 0/115 (0.00%)  0 0/65 (0.00%)  0
Photosensitivity  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  2
Pruritus  1  4/115 (3.48%)  5 1/115 (0.87%)  2 3/65 (4.62%)  3
Rash acneiform  1  5/115 (4.35%)  5 3/115 (2.61%)  3 1/65 (1.54%)  3
Rash desquamating  1  83/115 (72.17%)  243 49/115 (42.61%)  92 48/65 (73.85%)  137
Skin disorder  1  2/115 (1.74%)  3 3/115 (2.61%)  5 1/65 (1.54%)  1
Skin hyperpigmentation  1  0/115 (0.00%)  0 1/115 (0.87%)  1 0/65 (0.00%)  0
Skin induration  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Skin ulceration  1  1/115 (0.87%)  1 0/115 (0.00%)  0 0/65 (0.00%)  0
Vascular disorders       
Flushing  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  2
Hemorrhage  1  0/115 (0.00%)  0 0/115 (0.00%)  0 1/65 (1.54%)  2
Hot flashes  1  1/115 (0.87%)  1 8/115 (6.96%)  12 1/65 (1.54%)  1
Hypertension  1  1/115 (0.87%)  1 4/115 (3.48%)  5 1/65 (1.54%)  1
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: Lisa Carey, M.D.
Organization: University of North Carolina - Lineberger Comprehensive Cancer Center
EMail: lisa_carey@med.unc.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00770809    
Other Study ID Numbers: NCI-2009-01073
NCI-2009-01073 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000616648
CALGB 40601 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-40601 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: October 9, 2008
First Posted: October 10, 2008
Results First Submitted: May 7, 2015
Results First Posted: May 27, 2015
Last Update Posted: January 3, 2023