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Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors

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ClinicalTrials.gov Identifier: NCT01841736
Recruitment Status : Active, not recruiting
First Posted : April 26, 2013
Results First Posted : June 1, 2020
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Atypical Carcinoid Tumor
Foregut Carcinoid Tumor
Hindgut Carcinoid Tumor
Metastatic Carcinoid Tumor
Metastatic Digestive System Neuroendocrine Tumor G1
Midgut Neuroendocrine Tumor G1
Recurrent Digestive System Neuroendocrine Tumor G1
Regional Digestive System Neuroendocrine Tumor G1
Interventions Other: Laboratory Biomarker Analysis
Drug: Pazopanib Hydrochloride
Other: Placebo Administration
Other: Quality-of-Life Assessment
Enrollment 171
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Pazopanib Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
Period Title: Overall Study
Started 97 74
Crossover [1] 0 49
Completed [2] 97 74
Not Completed 0 0
[1]
Crossed over for pazopanib following disease progression on placebo
[2]
Included in efficacy analysis
Arm/Group Title Arm I (Pazopanib Hydrochloride) Arm II (Placebo) Total
Hide Arm/Group Description Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I. Total of all reporting groups
Overall Number of Baseline Participants 97 74 171
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 97 participants 74 participants 171 participants
62
(33 to 89)
63
(37 to 85)
63
(33 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 74 participants 171 participants
Female
63
  64.9%
33
  44.6%
96
  56.1%
Male
34
  35.1%
41
  55.4%
75
  43.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race (White vs Non-White) Number Analyzed 97 participants 74 participants 171 participants
Non-White
20
  20.6%
12
  16.2%
32
  18.7%
White
77
  79.4%
62
  83.8%
139
  81.3%
ECOG Performance status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 74 participants 171 participants
0
48
  49.5%
41
  55.4%
89
  52.0%
1
48
  49.5%
33
  44.6%
81
  47.4%
missing data
1
   1.0%
0
   0.0%
1
   0.6%
[1]
Measure Description: Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS will be measured from date of patient entry until documented progression of disease as determined by central review or death from any cause. If a patient does not have a documented date of progression or death, then PFS will be censored at the date of last adequate assessment. PFS will be estimated within treatment arm using the Kaplan-Meier method. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria.
Time Frame From date of patient entry until documented progression of disease or death from any cause, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pazopanib Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
Overall Number of Participants Analyzed 97 74
Median (80% Confidence Interval)
Unit of Measure: months
11.6
(11.0 to 13.0)
8.5
(5.8 to 8.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Pazopanib Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Log Rank
Comments Stratified log rank
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.53
Confidence Interval (2-Sided) 80%
0.42 to 0.69
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Best Response
Hide Description The best response per RECIST 1.1 criteria of participants receiving randomized treatment assignment. Complete response (CR): Disappearance of all evidence of disease, Partial response (PR): Regression of measurable disease and no new sites, Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study. Progressive disease (PD): Any new lesion or increase by ≥20% of previously involved sites from nadir. Note that those considered evaluable for best response here were those who had disease measurements while on treatment. Those who discontinued therapy early prior to a disease evaluation were not included.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, patients who crossover from placebo to active therapy at the time of progression will be followed for a second progression unless they withdraw from treatment for other reasons; in that case they will be followed for toxicity and survival only; thus response data are not available for "Placebo Crossover" group.
Arm/Group Title Arm I (Pazopanib Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
Overall Number of Participants Analyzed 97 74
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
2
   2.1%
0
   0.0%
Stable Disease
70
  72.2%
54
  73.0%
Progressive Disease
4
   4.1%
14
  18.9%
Not Evaluable
21
  21.6%
6
   8.1%
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) will be measured from randomization until death from any cause. A patient who is alive at the time of the statistical analysis will be considered censored at the last date of known contact. OS will be estimated by the Kaplan-Meier method within each treatment arm.
Time Frame From randomization until death from any cause, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
This trial only has two arms ((Arm I (pazopanib hydrochloride) and Arm II (placebo)) that were analyzed. Pazopanib hydrochloride and Pazopanib are synonyms and Pazopanib was deleted. Per protocol, OS will be estimated by the Kaplan-Meier method within each treatment arm. OS for placebo patients who crossed over is not a specified outcome measure.
Arm/Group Title Arm I (Pazopanib Hydrochloride) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
Overall Number of Participants Analyzed 97 74
Median (80% Confidence Interval)
Unit of Measure: months
41.3
(31.9 to 44.8)
42.4
(29.7 to 50.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Pazopanib Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method Log Rank
Comments Stratified Log-Rank
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Confidence Interval (2-Sided) 80%
0.84 to 1.51
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Duration of Response for the Subset of Patients With a Confirmed Complete Response or Partial Response
Hide Description Duration of response is defined as the time from documented response to time of progression and/or death. This time-to-event outcome will be summarized descriptively using the methods of Kaplan and Meier to characterize the cohort and distribution of this outcome.
Time Frame From first documented evidence of complete response or partial response until first documented disease progression or death from any cause, assessed up to 5 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure is defined as the time from randomization to the time that treatment is terminated, including the reasons of disease progression, adverse events, withdrawal from study, or death. This time-to-event outcome will be evaluated using the methods of Kaplan and Meier.
Time Frame From randomization until termination of protocol therapy for any reason including progression of disease, adverse events, and death, assessed up to 5 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time to Second Progression for Patients Who Crossover From Placebo to Active Therapy
Hide Description [Not Specified]
Time Frame Up to 5 years
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title PFS Within Each Arm
Hide Description Kaplan-Meier methods will be used including calculations of 95% confidence intervals.
Time Frame At 6 months
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Biochemical Response
Hide Description Biochemical response (for chromogranin A, defined as a decrease of 50% or more in chromogranin A levels from baseline, and for 5-hydroxyindoleacetic acid [5-HIAA], defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of serum chromogranin A (CGA) and 5-HIAA.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
Time Frame Up to 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Pazopanib Hydrochloride) Arm II (Placebo) Placebo Crossover
Hide Arm/Group Description Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I. Participants in Arm II (Placebo) who crossed over to receive pazopanib hydrochloride.
All-Cause Mortality
Arm I (Pazopanib Hydrochloride) Arm II (Placebo) Placebo Crossover
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   49/97 (50.52%)      40/74 (54.05%)      29/49 (59.18%)    
Hide Serious Adverse Events
Arm I (Pazopanib Hydrochloride) Arm II (Placebo) Placebo Crossover
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/97 (16.49%)      3/74 (4.05%)      2/49 (4.08%)    
General disorders       
Death NOS  1  10/97 (10.31%)  10 2/74 (2.70%)  2 0/49 (0.00%)  0
Sudden death NOS  1  1/97 (1.03%)  1 0/74 (0.00%)  0 1/49 (2.04%)  1
Infections and infestations       
Sepsis  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, mal, uncpec - Oth spec  1  4/97 (4.12%)  4 1/74 (1.35%)  1 1/49 (2.04%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Pazopanib Hydrochloride) Arm II (Placebo) Placebo Crossover
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   90/97 (92.78%)      71/74 (95.95%)      49/49 (100.00%)    
Blood and lymphatic system disorders       
Anemia  1  17/97 (17.53%)  67 13/74 (17.57%)  90 12/49 (24.49%)  28
Blood and lymph sys disorders - Oth Spec  1  1/97 (1.03%)  1 2/74 (2.70%)  7 0/49 (0.00%)  0
Leukocytosis  1  1/97 (1.03%)  1 1/74 (1.35%)  1 0/49 (0.00%)  0
Cardiac disorders       
Atrial fibrillation  1  0/97 (0.00%)  0 1/74 (1.35%)  2 1/49 (2.04%)  1
Atrial flutter  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Cardiac disorders - Other, specify  1  3/97 (3.09%)  5 2/74 (2.70%)  2 2/49 (4.08%)  3
Chest pain - cardiac  1  1/97 (1.03%)  1 1/74 (1.35%)  1 0/49 (0.00%)  0
Left ventricular systolic dysfunction  1  1/97 (1.03%)  6 0/74 (0.00%)  0 0/49 (0.00%)  0
Palpitations  1  1/97 (1.03%)  5 1/74 (1.35%)  11 2/49 (4.08%)  6
Pericardial effusion  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Pericardial tamponade  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Sinus bradycardia  1  3/97 (3.09%)  8 2/74 (2.70%)  11 2/49 (4.08%)  10
Tricuspid valve disease  1  2/97 (2.06%)  13 0/74 (0.00%)  0 0/49 (0.00%)  0
Ear and labyrinth disorders       
Ear and labyrinth disorders - Oth spec  1  3/97 (3.09%)  5 0/74 (0.00%)  0 0/49 (0.00%)  0
Ear pain  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Hearing impaired  1  0/97 (0.00%)  0 2/74 (2.70%)  38 1/49 (2.04%)  3
Tinnitus  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  10
Vertigo  1  2/97 (2.06%)  3 0/74 (0.00%)  0 0/49 (0.00%)  0
Endocrine disorders       
Endocrine disorders - Other, specify  1  2/97 (2.06%)  22 0/74 (0.00%)  0 0/49 (0.00%)  0
Hyperparathyroidism  1  1/97 (1.03%)  3 0/74 (0.00%)  0 0/49 (0.00%)  0
Hyperthyroidism  1  5/97 (5.15%)  11 1/74 (1.35%)  1 1/49 (2.04%)  5
Hypoparathyroidism  1  1/97 (1.03%)  7 0/74 (0.00%)  0 0/49 (0.00%)  0
Hypothyroidism  1  11/97 (11.34%)  55 2/74 (2.70%)  3 9/49 (18.37%)  13
Eye disorders       
Blurred vision  1  4/97 (4.12%)  5 0/74 (0.00%)  0 1/49 (2.04%)  1
Eye disorders - Other, specify  1  1/97 (1.03%)  4 0/74 (0.00%)  0 2/49 (4.08%)  3
Floaters  1  1/97 (1.03%)  3 0/74 (0.00%)  0 0/49 (0.00%)  0
Glaucoma  1  0/97 (0.00%)  0 1/74 (1.35%)  3 0/49 (0.00%)  0
Night blindness  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Periorbital edema  1  1/97 (1.03%)  5 0/74 (0.00%)  0 0/49 (0.00%)  0
Retinal detachment  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Watering eyes  1  1/97 (1.03%)  2 0/74 (0.00%)  0 0/49 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension  1  2/97 (2.06%)  4 3/74 (4.05%)  9 2/49 (4.08%)  3
Abdominal pain  1  23/97 (23.71%)  93 20/74 (27.03%)  35 13/49 (26.53%)  44
Ascites  1  1/97 (1.03%)  1 2/74 (2.70%)  2 1/49 (2.04%)  1
Bloating  1  4/97 (4.12%)  12 3/74 (4.05%)  3 1/49 (2.04%)  1
Colitis  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Colonic obstruction  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Constipation  1  9/97 (9.28%)  14 8/74 (10.81%)  26 4/49 (8.16%)  11
Dental caries  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Diarrhea  1  65/97 (67.01%)  664 42/74 (56.76%)  308 35/49 (71.43%)  206
Dry mouth  1  7/97 (7.22%)  41 0/74 (0.00%)  0 2/49 (4.08%)  5
Dyspepsia  1  7/97 (7.22%)  30 4/74 (5.41%)  5 2/49 (4.08%)  2
Dysphagia  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Esophagitis  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Flatulence  1  5/97 (5.15%)  49 3/74 (4.05%)  4 3/49 (6.12%)  5
Gastric hemorrhage  1  3/97 (3.09%)  3 0/74 (0.00%)  0 0/49 (0.00%)  0
Gastric ulcer  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Gastritis  1  0/97 (0.00%)  0 1/74 (1.35%)  1 1/49 (2.04%)  1
Gastroesophageal reflux disease  1  4/97 (4.12%)  12 3/74 (4.05%)  5 0/49 (0.00%)  0
Gastrointestinal disorders - Oth spec  1  9/97 (9.28%)  56 4/74 (5.41%)  4 2/49 (4.08%)  4
Gastrointestinal pain  1  0/97 (0.00%)  0 2/74 (2.70%)  2 1/49 (2.04%)  1
Gastroparesis  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Hemorrhoidal hemorrhage  1  1/97 (1.03%)  1 1/74 (1.35%)  3 0/49 (0.00%)  0
Hemorrhoids  1  1/97 (1.03%)  2 0/74 (0.00%)  0 0/49 (0.00%)  0
Malabsorption  1  1/97 (1.03%)  2 0/74 (0.00%)  0 0/49 (0.00%)  0
Mucositis oral  1  10/97 (10.31%)  17 6/74 (8.11%)  12 5/49 (10.20%)  10
Nausea  1  71/97 (73.20%)  326 37/74 (50.00%)  131 28/49 (57.14%)  107
Oral hemorrhage  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Oral pain  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Pancreatic duct stenosis  1  1/97 (1.03%)  7 0/74 (0.00%)  0 0/49 (0.00%)  0
Pancreatitis  1  1/97 (1.03%)  2 0/74 (0.00%)  0 0/49 (0.00%)  0
Rectal fistula  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Rectal hemorrhage  1  3/97 (3.09%)  4 0/74 (0.00%)  0 1/49 (2.04%)  1
Rectal pain  1  2/97 (2.06%)  3 0/74 (0.00%)  0 0/49 (0.00%)  0
Small intestinal obstruction  1  5/97 (5.15%)  6 5/74 (6.76%)  7 1/49 (2.04%)  2
Stomach pain  1  1/97 (1.03%)  1 1/74 (1.35%)  2 0/49 (0.00%)  0
Upper gastrointestinal hemorrhage  1  1/97 (1.03%)  1 1/74 (1.35%)  2 0/49 (0.00%)  0
Visceral arterial ischemia  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Vomiting  1  27/97 (27.84%)  53 10/74 (13.51%)  31 12/49 (24.49%)  21
General disorders       
Chills  1  4/97 (4.12%)  5 2/74 (2.70%)  2 3/49 (6.12%)  3
Edema face  1  2/97 (2.06%)  4 0/74 (0.00%)  0 1/49 (2.04%)  2
Edema limbs  1  12/97 (12.37%)  46 5/74 (6.76%)  28 9/49 (18.37%)  25
Facial pain  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Fatigue  1  80/97 (82.47%)  786 58/74 (78.38%)  370 42/49 (85.71%)  292
Fever  1  3/97 (3.09%)  3 1/74 (1.35%)  1 1/49 (2.04%)  1
Flu like symptoms  1  2/97 (2.06%)  3 3/74 (4.05%)  3 1/49 (2.04%)  3
Gen disord and admin site conds-Oth spec  1  6/97 (6.19%)  10 0/74 (0.00%)  0 1/49 (2.04%)  1
Localized edema  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Non-cardiac chest pain  1  7/97 (7.22%)  14 2/74 (2.70%)  3 2/49 (4.08%)  2
Pain  1  7/97 (7.22%)  10 4/74 (5.41%)  25 8/49 (16.33%)  12
Hepatobiliary disorders       
Gallbladder obstruction  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Portal hypertension  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Immune system disorders       
Allergic reaction  1  1/97 (1.03%)  8 0/74 (0.00%)  0 0/49 (0.00%)  0
Infections and infestations       
Catheter related infection  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Eye infection  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Gum infection  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Infections and infestations - Oth spec  1  0/97 (0.00%)  0 0/74 (0.00%)  0 2/49 (4.08%)  3
Kidney infection  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Lip infection  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Lung infection  1  2/97 (2.06%)  3 1/74 (1.35%)  1 0/49 (0.00%)  0
Lymph gland infection  1  1/97 (1.03%)  2 0/74 (0.00%)  0 0/49 (0.00%)  0
Papulopustular rash  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Paronychia  1  1/97 (1.03%)  5 0/74 (0.00%)  0 0/49 (0.00%)  0
Sinusitis  1  1/97 (1.03%)  2 1/74 (1.35%)  2 0/49 (0.00%)  0
Skin infection  1  1/97 (1.03%)  1 2/74 (2.70%)  3 1/49 (2.04%)  1
Upper respiratory infection  1  6/97 (6.19%)  18 1/74 (1.35%)  1 0/49 (0.00%)  0
Urinary tract infection  1  5/97 (5.15%)  6 2/74 (2.70%)  2 4/49 (8.16%)  4
Wound infection  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Injury, poisoning and procedural complications       
Bruising  1  7/97 (7.22%)  29 0/74 (0.00%)  0 0/49 (0.00%)  0
Fall  1  4/97 (4.12%)  5 4/74 (5.41%)  4 3/49 (6.12%)  3
Fracture  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Hip fracture  1  1/97 (1.03%)  2 1/74 (1.35%)  1 0/49 (0.00%)  0
Inj, pois and proced complic - Oth spec  1  1/97 (1.03%)  2 1/74 (1.35%)  1 0/49 (0.00%)  0
Pancreatic anastomotic leak  1  1/97 (1.03%)  7 0/74 (0.00%)  0 0/49 (0.00%)  0
Urostomy obstruction  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Investigations       
Alanine aminotransferase increased  1  54/97 (55.67%)  167 25/74 (33.78%)  97 27/49 (55.10%)  130
Alkaline phosphatase increased  1  14/97 (14.43%)  29 14/74 (18.92%)  49 13/49 (26.53%)  51
Aspartate aminotransferase increased  1  61/97 (62.89%)  229 26/74 (35.14%)  102 28/49 (57.14%)  129
Blood bilirubin increased  1  28/97 (28.87%)  103 15/74 (20.27%)  58 18/49 (36.73%)  91
Creatinine increased  1  8/97 (8.25%)  14 6/74 (8.11%)  15 2/49 (4.08%)  3
INR increased  1  2/97 (2.06%)  6 0/74 (0.00%)  0 0/49 (0.00%)  0
Investigations - Other, specify  1  3/97 (3.09%)  34 1/74 (1.35%)  1 2/49 (4.08%)  11
Lipase increased  1  3/97 (3.09%)  16 0/74 (0.00%)  0 0/49 (0.00%)  0
Lymphocyte count decreased  1  13/97 (13.40%)  64 6/74 (8.11%)  46 6/49 (12.24%)  18
Neutrophil count decreased  1  30/97 (30.93%)  134 3/74 (4.05%)  5 12/49 (24.49%)  46
Platelet count decreased  1  21/97 (21.65%)  156 5/74 (6.76%)  12 9/49 (18.37%)  21
Serum amylase increased  1  1/97 (1.03%)  2 0/74 (0.00%)  0 0/49 (0.00%)  0
Weight gain  1  0/97 (0.00%)  0 1/74 (1.35%)  2 0/49 (0.00%)  0
Weight loss  1  18/97 (18.56%)  99 7/74 (9.46%)  8 8/49 (16.33%)  30
White blood cell decreased  1  21/97 (21.65%)  133 4/74 (5.41%)  23 6/49 (12.24%)  28
Metabolism and nutrition disorders       
Anorexia  1  24/97 (24.74%)  56 12/74 (16.22%)  30 14/49 (28.57%)  37
Dehydration  1  8/97 (8.25%)  10 4/74 (5.41%)  4 1/49 (2.04%)  1
Hypercalcemia  1  1/97 (1.03%)  1 1/74 (1.35%)  1 0/49 (0.00%)  0
Hyperglycemia  1  21/97 (21.65%)  63 12/74 (16.22%)  72 5/49 (10.20%)  23
Hyperkalemia  1  9/97 (9.28%)  32 6/74 (8.11%)  23 4/49 (8.16%)  16
Hypermagnesemia  1  0/97 (0.00%)  0 2/74 (2.70%)  4 1/49 (2.04%)  4
Hypernatremia  1  5/97 (5.15%)  9 1/74 (1.35%)  1 0/49 (0.00%)  0
Hypoalbuminemia  1  12/97 (12.37%)  70 5/74 (6.76%)  8 6/49 (12.24%)  10
Hypocalcemia  1  5/97 (5.15%)  30 5/74 (6.76%)  13 3/49 (6.12%)  3
Hypoglycemia  1  4/97 (4.12%)  4 3/74 (4.05%)  10 1/49 (2.04%)  1
Hypokalemia  1  7/97 (7.22%)  19 4/74 (5.41%)  6 2/49 (4.08%)  4
Hypomagnesemia  1  11/97 (11.34%)  49 7/74 (9.46%)  30 4/49 (8.16%)  17
Hyponatremia  1  8/97 (8.25%)  13 3/74 (4.05%)  3 6/49 (12.24%)  22
Hypophosphatemia  1  7/97 (7.22%)  12 4/74 (5.41%)  14 4/49 (8.16%)  19
Metabolism, nutrition disord - Oth spec  1  2/97 (2.06%)  3 2/74 (2.70%)  13 1/49 (2.04%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/97 (2.06%)  31 2/74 (2.70%)  20 3/49 (6.12%)  11
Arthritis  1  0/97 (0.00%)  0 1/74 (1.35%)  3 1/49 (2.04%)  1
Back pain  1  7/97 (7.22%)  31 10/74 (13.51%)  32 6/49 (12.24%)  20
Bone pain  1  1/97 (1.03%)  1 3/74 (4.05%)  16 3/49 (6.12%)  3
Buttock pain  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Chest wall pain  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Flank pain  1  3/97 (3.09%)  5 4/74 (5.41%)  16 3/49 (6.12%)  6
Generalized muscle weakness  1  7/97 (7.22%)  20 5/74 (6.76%)  11 5/49 (10.20%)  12
Muscle weakness lower limb  1  1/97 (1.03%)  1 2/74 (2.70%)  3 0/49 (0.00%)  0
Musculoskeletal, conn tissue - Oth spec  1  3/97 (3.09%)  5 2/74 (2.70%)  13 2/49 (4.08%)  4
Myalgia  1  7/97 (7.22%)  13 4/74 (5.41%)  21 3/49 (6.12%)  8
Neck pain  1  0/97 (0.00%)  0 1/74 (1.35%)  1 1/49 (2.04%)  3
Osteonecrosis of jaw  1  0/97 (0.00%)  0 1/74 (1.35%)  2 1/49 (2.04%)  1
Osteoporosis  1  1/97 (1.03%)  10 0/74 (0.00%)  0 0/49 (0.00%)  0
Pain in extremity  1  7/97 (7.22%)  64 3/74 (4.05%)  6 5/49 (10.20%)  17
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Leukemia second to oncology chemo  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Neoplasms benign, mal, uncpec - Oth spec  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Nervous system disorders       
Cognitive disturbance  1  1/97 (1.03%)  7 0/74 (0.00%)  0 0/49 (0.00%)  0
Concentration impairment  1  1/97 (1.03%)  1 0/74 (0.00%)  0 1/49 (2.04%)  2
Dizziness  1  12/97 (12.37%)  23 6/74 (8.11%)  27 5/49 (10.20%)  15
Dysgeusia  1  14/97 (14.43%)  84 1/74 (1.35%)  1 2/49 (4.08%)  8
Encephalopathy  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Headache  1  19/97 (19.59%)  47 7/74 (9.46%)  32 6/49 (12.24%)  17
Ischemia cerebrovascular  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Lethargy  1  0/97 (0.00%)  0 1/74 (1.35%)  16 1/49 (2.04%)  3
Memory impairment  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Nervous system disorders - Oth spec  1  1/97 (1.03%)  1 1/74 (1.35%)  1 2/49 (4.08%)  3
Neuralgia  1  1/97 (1.03%)  8 0/74 (0.00%)  0 0/49 (0.00%)  0
Paresthesia  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  2
Peripheral sensory neuropathy  1  2/97 (2.06%)  12 6/74 (8.11%)  8 1/49 (2.04%)  8
Presyncope  1  1/97 (1.03%)  1 1/74 (1.35%)  2 1/49 (2.04%)  4
Seizure  1  2/97 (2.06%)  2 0/74 (0.00%)  0 0/49 (0.00%)  0
Somnolence  1  0/97 (0.00%)  0 1/74 (1.35%)  22 1/49 (2.04%)  8
Stroke  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  2
Syncope  1  2/97 (2.06%)  4 2/74 (2.70%)  2 1/49 (2.04%)  2
Transient ischemic attacks  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Tremor  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Psychiatric disorders       
Anxiety  1  0/97 (0.00%)  0 4/74 (5.41%)  15 3/49 (6.12%)  4
Confusion  1  3/97 (3.09%)  3 1/74 (1.35%)  21 2/49 (4.08%)  9
Delirium  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Depression  1  4/97 (4.12%)  13 2/74 (2.70%)  12 1/49 (2.04%)  7
Hallucinations  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Insomnia  1  5/97 (5.15%)  35 8/74 (10.81%)  31 6/49 (12.24%)  25
Psychiatric disorders - Other, specify  1  2/97 (2.06%)  2 1/74 (1.35%)  3 1/49 (2.04%)  7
Renal and urinary disorders       
Acute kidney injury  1  1/97 (1.03%)  1 0/74 (0.00%)  0 1/49 (2.04%)  1
Chronic kidney disease  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Hematuria  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Proteinuria  1  8/97 (8.25%)  27 4/74 (5.41%)  6 1/49 (2.04%)  1
Renal and urinary disorders - Oth spec  1  2/97 (2.06%)  4 1/74 (1.35%)  1 2/49 (4.08%)  3
Renal calculi  1  1/97 (1.03%)  1 2/74 (2.70%)  4 1/49 (2.04%)  4
Urinary frequency  1  1/97 (1.03%)  2 1/74 (1.35%)  2 0/49 (0.00%)  0
Urinary incontinence  1  0/97 (0.00%)  0 2/74 (2.70%)  2 1/49 (2.04%)  1
Urinary retention  1  0/97 (0.00%)  0 2/74 (2.70%)  28 1/49 (2.04%)  3
Urinary tract obstruction  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Urinary urgency  1  2/97 (2.06%)  9 0/74 (0.00%)  0 0/49 (0.00%)  0
Reproductive system and breast disorders       
Gynecomastia  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Irregular menstruation  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Menorrhagia  1  0/97 (0.00%)  0 1/74 (1.35%)  8 1/49 (2.04%)  4
Testicular pain  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Vaginal pain  1  1/97 (1.03%)  2 0/74 (0.00%)  0 0/49 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  2/97 (2.06%)  2 3/74 (4.05%)  8 0/49 (0.00%)  0
Cough  1  8/97 (8.25%)  38 3/74 (4.05%)  4 4/49 (8.16%)  16
Dyspnea  1  17/97 (17.53%)  54 3/74 (4.05%)  4 4/49 (8.16%)  16
Epistaxis  1  3/97 (3.09%)  4 1/74 (1.35%)  1 2/49 (4.08%)  2
Hoarseness  1  1/97 (1.03%)  2 0/74 (0.00%)  0 0/49 (0.00%)  0
Hypoxia  1  2/97 (2.06%)  2 1/74 (1.35%)  1 1/49 (2.04%)  1
Laryngeal inflammation  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Nasal congestion  1  1/97 (1.03%)  2 0/74 (0.00%)  0 0/49 (0.00%)  0
Pharyngeal hemorrhage  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  3
Pleural effusion  1  0/97 (0.00%)  0 0/74 (0.00%)  0 2/49 (4.08%)  8
Pleuritic pain  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Pneumonitis  1  2/97 (2.06%)  5 1/74 (1.35%)  1 0/49 (0.00%)  0
Postnasal drip  1  1/97 (1.03%)  3 1/74 (1.35%)  1 1/49 (2.04%)  10
Productive cough  1  0/97 (0.00%)  0 1/74 (1.35%)  8 0/49 (0.00%)  0
Resp, thoracic, mediastinal - Oth spec  1  3/97 (3.09%)  4 0/74 (0.00%)  0 0/49 (0.00%)  0
Sinus pain  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Sleep apnea  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Sore throat  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia  1  13/97 (13.40%)  154 1/74 (1.35%)  1 2/49 (4.08%)  14
Dry skin  1  3/97 (3.09%)  13 4/74 (5.41%)  9 3/49 (6.12%)  6
Erythema multiforme  1  2/97 (2.06%)  15 0/74 (0.00%)  0 0/49 (0.00%)  0
Hyperhidrosis  1  2/97 (2.06%)  2 2/74 (2.70%)  2 0/49 (0.00%)  0
Hypertrichosis  1  0/97 (0.00%)  0 1/74 (1.35%)  2 0/49 (0.00%)  0
Nail ridging  1  1/97 (1.03%)  2 0/74 (0.00%)  0 0/49 (0.00%)  0
Pain of skin  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Palmar-plantar erythrodysesthesia syndrm  1  6/97 (6.19%)  27 1/74 (1.35%)  1 2/49 (4.08%)  24
Pruritus  1  4/97 (4.12%)  9 4/74 (5.41%)  11 0/49 (0.00%)  0
Purpura  1  0/97 (0.00%)  0 1/74 (1.35%)  1 0/49 (0.00%)  0
Rash acneiform  1  0/97 (0.00%)  0 3/74 (4.05%)  4 3/49 (6.12%)  5
Rash maculo-papular  1  6/97 (6.19%)  26 1/74 (1.35%)  1 3/49 (6.12%)  17
Skin and subcut tissue disord - Oth spec  1  21/97 (21.65%)  237 8/74 (10.81%)  31 8/49 (16.33%)  28
Skin atrophy  1  1/97 (1.03%)  2 0/74 (0.00%)  0 0/49 (0.00%)  0
Skin hyperpigmentation  1  2/97 (2.06%)  9 0/74 (0.00%)  0 2/49 (4.08%)  2
Skin hypopigmentation  1  3/97 (3.09%)  34 0/74 (0.00%)  0 2/49 (4.08%)  24
Skin ulceration  1  0/97 (0.00%)  0 0/74 (0.00%)  0 1/49 (2.04%)  1
Surgical and medical procedures       
Surgical and medical proced - Oth spec  1  1/97 (1.03%)  1 1/74 (1.35%)  1 0/49 (0.00%)  0
Vascular disorders       
Flushing  1  4/97 (4.12%)  12 5/74 (6.76%)  23 5/49 (10.20%)  22
Hematoma  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Hot flashes  1  7/97 (7.22%)  25 5/74 (6.76%)  35 4/49 (8.16%)  15
Hypertension  1  68/97 (70.10%)  695 46/74 (62.16%)  346 35/49 (71.43%)  215
Hypotension  1  1/97 (1.03%)  2 0/74 (0.00%)  0 1/49 (2.04%)  1
Lymphedema  1  1/97 (1.03%)  1 0/74 (0.00%)  0 0/49 (0.00%)  0
Thromboembolic event  1  2/97 (2.06%)  2 0/74 (0.00%)  0 1/49 (2.04%)  1
Vascular disorders - Other, specify  1  0/97 (0.00%)  0 2/74 (2.70%)  3 1/49 (2.04%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
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: Emily Bergsland, M.D.
Organization: UCSF Helen Diller Family Comprehensive Cancer Center
Phone: 415-353-9888
EMail: emily.bergsland@ucsf.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01841736    
Other Study ID Numbers: NCI-2013-00831
NCI-2013-00831 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ALLIANCE A021202
CALGB-A021202
A021202 ( Other Identifier: Alliance for Clinical Trials in Oncology )
A021202 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA180830 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: April 24, 2013
First Posted: April 26, 2013
Results First Submitted: February 14, 2020
Results First Posted: June 1, 2020
Last Update Posted: May 17, 2021