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Trial record 48 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-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: NCT00684983
Recruitment Status : Active, not recruiting
First Posted : May 28, 2008
Results First Posted : October 6, 2014
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
Southwest Oncology Group
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 HER2 Positive Breast Carcinoma
Recurrent Breast Carcinoma
Stage IIIB Breast Cancer AJCC v7
Stage IIIC Breast Cancer AJCC v7
Stage IV Breast Cancer AJCC v6 and v7
Interventions Drug: Capecitabine
Biological: Cixutumumab
Drug: Lapatinib
Drug: Lapatinib Ditosylate
Other: Quality-of-Life Assessment
Enrollment 64
Recruitment Details Total of 68 (Arm A:20, B: 48) patients were accrued, 8 safety cohort patients from arm B are not eligible for primary end point analysis. There were 3 cancels (Arm B), 1 ineligible (arm A) and 1 major violation (Arm B, this patient is included in the primary analysis per protocol). Total of 64 patients started and completed the treatment.
Pre-assignment Details  
Arm/Group Title Arm A Arm B
Hide Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
Period Title: Overall Study
Started 19 45
Completed 19 45 [1]
Not Completed 0 0
[1]
One major violation patient in Arm B is included in the primary analysis per protocol.
Arm/Group Title Arm A Arm B Total
Hide Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO Total of all reporting groups
Overall Number of Baseline Participants 19 45 64
Hide Baseline Analysis Population Description
Total of 68 patient were accrued. Three are cancels and one is ineligible. Sixty four (64) started the study treatment.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants 45 participants 64 participants
57
(35 to 75)
53
(29 to 78)
53.5
(29 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 45 participants 64 participants
Female
19
 100.0%
45
 100.0%
64
 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 19 participants 45 participants 64 participants
19 45 64
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.
Time Frame From randomization to the earliest date of documentation of disease progression, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
First 8 patients in Arm B are from safety cohort, they are not eligible for primary end point
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
Overall Number of Participants Analyzed 19 37
Median (95% Confidence Interval)
Unit of Measure: Median survival and CI in months
6.0
(4.3 to 8.6)
4.9
(2.9 to 8.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .89
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.58 to 1.89
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description Median Survival time (months)
Time Frame From randomization to death due to any cause, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
Overall Number of Participants Analyzed 19 37
Median (Full Range)
Unit of Measure: Months
16.8
(1.7 to 37.9)
14.7
(3.1 to 47.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.5 to 3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Treatment Failure
Hide Description Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.
Time Frame From the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
Overall Number of Participants Analyzed 19 37
Median (Full Range)
Unit of Measure: Months
4.6
(0.4 to 12)
4.4
(.8 to 24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .66
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
.53 to 1.92
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Confirmed Tumor Response, Defined as Either a Complete Response (CR) or Partial Response (PR) Noted as the Objective Status on 2 Consecutive Evaluations at Least 6 Weeks Apart, Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Hide Description [Not Specified]
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients with at least one disease assessment at least 6 weeks after registration.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
Overall Number of Participants Analyzed 16 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of evaluable participants
43.8
(19.8 to 70.1)
29
(14.2 to 48)
5.Secondary Outcome
Title Duration of Response
Hide Description Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable patients that had a response to treatment drug
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
Overall Number of Participants Analyzed 7 9
Median (Full Range)
Unit of Measure: Months
4.8
(3.2 to 8.6)
6.9
(3 to 21.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .26
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .39
Confidence Interval (2-Sided) 95%
.09 to 1.53
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Adverse Event Profile of Capecitabine and Lapatinib With and Without IMC-A12 (Using NCI CTCAE v3.0)
Hide Description

All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s) according to CTCAE v3.0 within each treatment arm. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

4/19 (21.05%) 14/45 (31.11%)

Time Frame Baseline to 30 days past end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Lapatinib Ditosylate, Capecitabine) Arm II (Cixutumumab, Lapatinib Ditosylate, Capecitabine)
Hide Arm/Group Description:

Patients receive capecitabine PO BID on days 1-14 and lapatinib ditosylate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given PO

Laboratory Biomarker Analysis: Correlative studies

Lapatinib Ditosylate: Given PO

Quality-of-Life Assessment: Ancillary studies

Patients receive capecitabine and lapatinib ditosylate as in Arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given PO

Cixutumumab: Given IV

Laboratory Biomarker Analysis: Correlative studies

Lapatinib Ditosylate: Given PO

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 19 45
Measure Type: Number
Unit of Measure: percentage of patients with AEs
21 31
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A Arm B
Hide Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
All-Cause Mortality
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/19 (21.05%)      14/45 (31.11%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Hemolysis  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Gastrointestinal disorders     
Diarrhea  1  2/19 (10.53%)  2 1/45 (2.22%)  2
Ear, nose and throat examination abnormal  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Esophageal ulcer  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Gastritis  1  1/19 (5.26%)  1 1/45 (2.22%)  1
Mucositis oral  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Nausea  1  1/19 (5.26%)  1 1/45 (2.22%)  1
Vomiting  1  1/19 (5.26%)  1 1/45 (2.22%)  1
General disorders     
Chest pain  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Chills  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Disease progression  1  1/19 (5.26%)  1 0/45 (0.00%)  0
Fatigue  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Fever  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Pain  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Hepatobiliary disorders     
Cholecystitis  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Infections and infestations     
Lip infection  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Nail infection  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Skin infection  1  1/19 (5.26%)  1 0/45 (0.00%)  0
Soft tissue infection  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Upper respiratory infection  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Urinary tract infection  1  1/19 (5.26%)  1 0/45 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  1/19 (5.26%)  1 0/45 (0.00%)  0
Aspartate aminotransferase increased  1  1/19 (5.26%)  1 0/45 (0.00%)  0
Creatinine increased  1  0/19 (0.00%)  0 2/45 (4.44%)  2
Neutrophil count decreased  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Platelet count decreased  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Metabolism and nutrition disorders     
Dehydration  1  1/19 (5.26%)  1 1/45 (2.22%)  1
Serum calcium decreased  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Serum potassium decreased  1  0/19 (0.00%)  0 2/45 (4.44%)  2
Serum sodium decreased  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Musculoskeletal and connective tissue disorders     
Bone pain  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Pain in extremity  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Nervous system disorders     
Extrapyramidal disorder  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Headache  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Seizure  1  1/19 (5.26%)  1 0/45 (0.00%)  0
Psychiatric disorders     
Anxiety  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Skin and subcutaneous tissue disorders     
Nail disorder  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Skin disorder  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Vascular disorders     
Hypotension  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Thrombosis  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/19 (100.00%)      43/45 (95.56%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  11/19 (57.89%)  57 26/45 (57.78%)  137
Lymph node pain  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Cardiac disorders     
Left ventricular failure  1  1/19 (5.26%)  1 1/45 (2.22%)  3
Palpitations  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Ventricular bigeminy  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Eye disorders     
Dry eye syndrome  1  0/19 (0.00%)  0 2/45 (4.44%)  2
Flashing vision  1  0/19 (0.00%)  0 4/45 (8.89%)  12
Vision blurred  1  1/19 (5.26%)  2 5/45 (11.11%)  6
Gastrointestinal disorders     
Abdominal pain  1  0/19 (0.00%)  0 3/45 (6.67%)  3
Cheilitis  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Constipation  1  2/19 (10.53%)  2 8/45 (17.78%)  26
Diarrhea  1  16/19 (84.21%)  46 35/45 (77.78%)  133
Dry mouth  1  0/19 (0.00%)  0 3/45 (6.67%)  17
Dyspepsia  1  1/19 (5.26%)  1 4/45 (8.89%)  8
Dysphagia  1  0/19 (0.00%)  0 2/45 (4.44%)  2
Ear, nose and throat examination abnormal  1  10/19 (52.63%)  20 21/45 (46.67%)  49
Esophageal pain  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Gastritis  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Mucositis oral  1  10/19 (52.63%)  14 22/45 (48.89%)  35
Nausea  1  9/19 (47.37%)  11 22/45 (48.89%)  63
Proctoscopy abnormal  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Stomach pain  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Toothache  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Vomiting  1  3/19 (15.79%)  4 9/45 (20.00%)  16
General disorders     
Chest pain  1  1/19 (5.26%)  1 0/45 (0.00%)  0
Chills  1  1/19 (5.26%)  2 1/45 (2.22%)  1
Fatigue  1  17/19 (89.47%)  83 37/45 (82.22%)  175
Fever  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Localized edema  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Pain  1  1/19 (5.26%)  1 3/45 (6.67%)  5
Pericardial pain  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Immune system disorders     
Cytokine release syndrome  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Hypersensitivity  1  2/19 (10.53%)  2 1/45 (2.22%)  3
Infections and infestations     
Catheter related infection  1  0/19 (0.00%)  0 1/45 (2.22%)  2
Infection  1  0/19 (0.00%)  0 1/45 (2.22%)  15
Nail infection  1  0/19 (0.00%)  0 3/45 (6.67%)  12
Skin infection  1  0/19 (0.00%)  0 2/45 (4.44%)  2
Urinary tract infection  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Wound infection  1  1/19 (5.26%)  1 0/45 (0.00%)  0
Injury, poisoning and procedural complications     
Bruising  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Thermal burn  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Vascular access complication  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Investigations     
Alanine aminotransferase increased  1  4/19 (21.05%)  8 10/45 (22.22%)  26
Alkaline phosphatase increased  1  0/19 (0.00%)  0 5/45 (11.11%)  7
Amylase increased  1  2/19 (10.53%)  3 3/45 (6.67%)  3
Aspartate aminotransferase increased  1  9/19 (47.37%)  22 11/45 (24.44%)  21
Bilirubin increased  1  5/19 (26.32%)  12 6/45 (13.33%)  20
Coagulopathy  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Creatinine increased  1  1/19 (5.26%)  1 5/45 (11.11%)  19
INR increased  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Laboratory test abnormal  1  0/19 (0.00%)  0 1/45 (2.22%)  6
Leukocyte count decreased  1  3/19 (15.79%)  3 6/45 (13.33%)  12
Lipase increased  1  2/19 (10.53%)  2 4/45 (8.89%)  4
Lymphocyte count decreased  1  1/19 (5.26%)  1 3/45 (6.67%)  7
Neutrophil count decreased  1  6/19 (31.58%)  19 9/45 (20.00%)  29
Platelet count decreased  1  2/19 (10.53%)  2 10/45 (22.22%)  31
Serum cholesterol increased  1  1/19 (5.26%)  1 3/45 (6.67%)  8
Weight loss  1  1/19 (5.26%)  1 11/45 (24.44%)  45
Metabolism and nutrition disorders     
Anorexia  1  2/19 (10.53%)  4 15/45 (33.33%)  46
Blood glucose increased  1  9/19 (47.37%)  18 29/45 (64.44%)  131
Dehydration  1  0/19 (0.00%)  0 3/45 (6.67%)  4
Glucose intolerance  1  2/19 (10.53%)  3 4/45 (8.89%)  21
Hypertriglyceridemia  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Hypomagnesemia  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Serum albumin decreased  1  2/19 (10.53%)  2 1/45 (2.22%)  1
Serum calcium decreased  1  0/19 (0.00%)  0 4/45 (8.89%)  7
Serum calcium increased  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Serum magnesium decreased  1  0/19 (0.00%)  0 7/45 (15.56%)  10
Serum phosphate decreased  1  0/19 (0.00%)  0 1/45 (2.22%)  2
Serum potassium decreased  1  1/19 (5.26%)  2 5/45 (11.11%)  13
Serum potassium increased  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Serum sodium decreased  1  0/19 (0.00%)  0 2/45 (4.44%)  8
Serum triglycerides increased  1  0/19 (0.00%)  0 4/45 (8.89%)  14
Musculoskeletal and connective tissue disorders     
Back pain  1  0/19 (0.00%)  0 2/45 (4.44%)  7
Bone pain  1  1/19 (5.26%)  1 0/45 (0.00%)  0
Chest wall pain  1  0/19 (0.00%)  0 2/45 (4.44%)  2
Joint pain  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Myalgia  1  0/19 (0.00%)  0 4/45 (8.89%)  4
Neck pain  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Pain in extremity  1  0/19 (0.00%)  0 3/45 (6.67%)  6
Nervous system disorders     
Ataxia  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Dizziness  1  2/19 (10.53%)  2 2/45 (4.44%)  3
Extrapyramidal disorder  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Headache  1  0/19 (0.00%)  0 3/45 (6.67%)  10
Memory impairment  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Peripheral motor neuropathy  1  2/19 (10.53%)  6 0/45 (0.00%)  0
Peripheral sensory neuropathy  1  4/19 (21.05%)  14 7/45 (15.56%)  13
Seizure  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Taste alteration  1  0/19 (0.00%)  0 11/45 (24.44%)  27
Tremor  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Psychiatric disorders     
Anxiety  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Confusion  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Depression  1  0/19 (0.00%)  0 2/45 (4.44%)  3
Insomnia  1  0/19 (0.00%)  0 5/45 (11.11%)  11
Renal and urinary disorders     
Hemorrhage urinary tract  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Protein urine positive  1  0/19 (0.00%)  0 2/45 (4.44%)  2
Reproductive system and breast disorders     
Breast pain  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Vaginal dryness  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  0/19 (0.00%)  0 2/45 (4.44%)  3
Cough  1  1/19 (5.26%)  1 2/45 (4.44%)  2
Dyspnea  1  1/19 (5.26%)  1 5/45 (11.11%)  9
Hemorrhage nasal  1  0/19 (0.00%)  0 7/45 (15.56%)  14
Pharyngeal examination abnormal  1  1/19 (5.26%)  1 5/45 (11.11%)  8
Pharyngeal mucositis  1  1/19 (5.26%)  1 5/45 (11.11%)  9
Pharyngolaryngeal pain  1  0/19 (0.00%)  0 1/45 (2.22%)  4
Pneumonitis  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  0/19 (0.00%)  0 3/45 (6.67%)  7
Dry skin  1  4/19 (21.05%)  7 6/45 (13.33%)  11
Erythema multiforme  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Hand-and-foot syndrome  1  14/19 (73.68%)  52 28/45 (62.22%)  118
Nail disorder  1  0/19 (0.00%)  0 7/45 (15.56%)  28
Pruritus  1  5/19 (26.32%)  7 9/45 (20.00%)  24
Rash acneiform  1  2/19 (10.53%)  2 2/45 (4.44%)  10
Rash desquamating  1  9/19 (47.37%)  20 21/45 (46.67%)  52
Skin disorder  1  0/19 (0.00%)  0 2/45 (4.44%)  7
Skin hyperpigmentation  1  0/19 (0.00%)  0 1/45 (2.22%)  2
Urticaria  1  2/19 (10.53%)  2 1/45 (2.22%)  4
Vascular disorders     
Hot flashes  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Hypertension  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Hypotension  1  0/19 (0.00%)  0 1/45 (2.22%)  1
Lymphedema  1  1/19 (5.26%)  1 0/45 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
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
Name/Title: Paul Haluska Jr MD PhD
Organization: Mayo Clinic
Phone: 507-284-1159
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00684983     History of Changes
Other Study ID Numbers: NCI-2009-00665
NCI-2009-00665 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PN0733_A15PAMDREVW01
CDR0000596070
NCCTG-N0733
NCCTG N0733
N0733 ( Other Identifier: Alliance for Clinical Trials in Oncology )
N0733 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA025224 ( U.S. NIH Grant/Contract )
First Submitted: May 22, 2008
First Posted: May 28, 2008
Results First Submitted: October 1, 2014
Results First Posted: October 6, 2014
Last Update Posted: June 27, 2019