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Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy

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ClinicalTrials.gov Identifier: NCT00693992
Recruitment Status : Completed
First Posted : June 9, 2008
Results First Posted : February 2, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Stage IIIB Non-Small Cell Lung Cancer
Stage IV Non-Small Cell Lung Cancer
Interventions Other: Laboratory Biomarker Analysis
Other: Placebo
Other: Quality-of-Life Assessment
Drug: Sunitinib Malate
Enrollment 210
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
Hide Arm/Group Description

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Sunitinib Malate: Given PO

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Quality-of-Life Assessment: Ancillary studies

Period Title: Overall Study
Started 106 104
Completed 106 104
Not Completed 0 0
Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo) Total
Hide Arm/Group Description

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Sunitinib Malate: Given PO

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Quality-of-Life Assessment: Ancillary studies

Total of all reporting groups
Overall Number of Baseline Participants 106 104 210
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 106 participants 104 participants 210 participants
65
(25 to 84)
67
(44 to 89)
66
(25 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 104 participants 210 participants
Female
49
  46.2%
44
  42.3%
93
  44.3%
Male
57
  53.8%
60
  57.7%
117
  55.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 104 participants 210 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
   2.9%
3
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
  17.0%
13
  12.5%
31
  14.8%
White
87
  82.1%
85
  81.7%
172
  81.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.9%
3
   2.9%
4
   1.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 106 participants 104 participants 210 participants
106 104 210
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression Free Survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.
Time Frame Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Sunitinib Malate: Given PO

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 106 104
Median (95% Confidence Interval)
Unit of Measure: months
4.3
(3.2 to 4.9)
2.6
(1.8 to 3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Sunitinib Malate), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.47 to 0.82
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Time Frame Time from randomization to death (up to 5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Sunitinib Malate: Given PO

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 106 104
Median (95% Confidence Interval)
Unit of Measure: months
11.7
(9.9 to 14.0)
12.1
(9.8 to 15.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Sunitinib Malate), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.73 to 1.31
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Response Rate (RR)
Hide Description

The percentage of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (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 Duration of treatment (up to 5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Sunitinib Malate: Given PO

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 106 104
Measure Type: Number
Unit of Measure: percentage of participants
11 5
4.Secondary Outcome
Title Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale
Hide Description The percentage of patients with at least a 10% drop in the EORTC-QLQ-C30 Global Health Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.
Time Frame At 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the EORTC-QLQ-C30 Global Health Subscale at baseline and 3 months were included in this analysis.
Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Sunitinib Malate: Given PO

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 80 83
Measure Type: Number
Unit of Measure: percentage of patients
55.8 28.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Sunitinib Malate), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0061
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale
Hide Description The percentage of patients with at least a 10% drop in the EORTC LC13 Dyspnea Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.
Time Frame At 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the EORTC LC13 Dyspnea Subscale at baseline and 3 months were included in this analysis.
Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Sunitinib Malate: Given PO

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 83 85
Measure Type: Number
Unit of Measure: percentage of patients
31.5 29.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Sunitinib Malate), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8393
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hide Description Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.
Time Frame Duration of study (up to 5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
189 participants were evaluable for adverse events.
Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Sunitinib Malate: Given PO

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 97 92
Measure Type: Number
Unit of Measure: percentage of participants
Fatigue 26 0
Thrombocytopenia 12 0
Hypertension 12 0
Rash 11 0
Mucositis 11 0
Neutropenia 7 0
Anemia 6 0
7.Other Pre-specified Outcome
Title VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS
Hide Description [Not Specified]
Time Frame Up to 6 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description 189 participants were evaluable for adverse events.
 
Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
Hide Arm/Group Description

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Sunitinib Malate: Given PO

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Quality-of-Life Assessment: Ancillary studies

All-Cause Mortality
Arm I (Sunitinib Malate) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Sunitinib Malate) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/97 (34.02%)      14/92 (15.22%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  10/97 (10.31%)  11 1/92 (1.09%)  1
Hemolysis  1  0/97 (0.00%)  0 1/92 (1.09%)  1
Cardiac disorders     
Cardiac disorder  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Conduction disorder  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Left ventricular failure  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Myocardial ischemia  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Palpitations  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Ear and labyrinth disorders     
External ear inflammation  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  2/97 (2.06%)  3 0/92 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Constipation  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Diarrhea  1  5/97 (5.15%)  6 1/92 (1.09%)  1
Duodenal hemorrhage  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Dyspepsia  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Dysphagia  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Gastrointestinal disorder  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Mucositis oral  1  5/97 (5.15%)  5 0/92 (0.00%)  0
Nausea  1  9/97 (9.28%)  10 5/92 (5.43%)  5
Oral hemorrhage  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Pancreatitis  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Upper gastrointestinal hemorrhage  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Vomiting  1  4/97 (4.12%)  4 1/92 (1.09%)  1
General disorders     
Chest pain  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Fatigue  1  26/97 (26.80%)  34 8/92 (8.70%)  9
Fever  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Localized edema  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Pain  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Sudden death  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Immune system disorders     
Immune system disorder  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Infections and infestations     
Infection without neutropenia  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Pneumonia  1  3/97 (3.09%)  3 0/92 (0.00%)  0
Sepsis  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Skin infection  1  0/97 (0.00%)  0 1/92 (1.09%)  1
Urinary tract infection  1  3/97 (3.09%)  3 0/92 (0.00%)  0
Injury, poisoning and procedural complications     
Fracture  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Alkaline phosphatase increased  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Amylase increased  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Aspartate aminotransferase increased  1  4/97 (4.12%)  4 0/92 (0.00%)  0
Electrocardiogram QTc interval prolonged  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Leukocyte count decreased  1  3/97 (3.09%)  4 1/92 (1.09%)  1
Lipase increased  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Lymphocyte count decreased  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Neutrophil count decreased  1  4/97 (4.12%)  4 0/92 (0.00%)  0
Platelet count decreased  1  9/97 (9.28%)  11 0/92 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  12/97 (12.37%)  13 2/92 (2.17%)  3
Blood glucose increased  1  1/97 (1.03%)  1 2/92 (2.17%)  2
Dehydration  1  4/97 (4.12%)  4 0/92 (0.00%)  0
Serum albumin decreased  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Serum calcium decreased  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Serum magnesium decreased  1  1/97 (1.03%)  1 1/92 (1.09%)  1
Serum phosphate decreased  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Serum potassium increased  1  0/97 (0.00%)  0 1/92 (1.09%)  1
Serum sodium decreased  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Serum sodium increased  1  0/97 (0.00%)  0 1/92 (1.09%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Bone pain  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Chest wall pain  1  1/97 (1.03%)  1 1/92 (1.09%)  1
Muscle weakness  1  3/97 (3.09%)  3 1/92 (1.09%)  1
Neck pain  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Pain in extremity  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Nervous system disorders     
Cognitive disturbance  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Depressed level of consciousness  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Dizziness  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Dysgeusia  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Encephalopathy  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Headache  1  1/97 (1.03%)  2 0/92 (0.00%)  0
Ischemia cerebrovascular  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Peripheral motor neuropathy  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Peripheral sensory neuropathy  1  3/97 (3.09%)  3 0/92 (0.00%)  0
Syncope  1  0/97 (0.00%)  0 1/92 (1.09%)  1
Psychiatric disorders     
Confusion  1  0/97 (0.00%)  0 1/92 (1.09%)  1
Depression  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Insomnia  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Renal and urinary disorders     
Proteinuria  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Renal failure  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Bronchial obstruction  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Cough  1  3/97 (3.09%)  3 2/92 (2.17%)  2
Dyspnea  1  7/97 (7.22%)  7 5/92 (5.43%)  5
Epistaxis  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Hypoxia  1  3/97 (3.09%)  3 2/92 (2.17%)  2
Pleural effusion  1  0/97 (0.00%)  0 1/92 (1.09%)  1
Pulmonary hemorrhage  1  1/97 (1.03%)  1 1/92 (1.09%)  1
Respiratory disorder  1  1/97 (1.03%)  1 1/92 (1.09%)  1
Skin and subcutaneous tissue disorders     
Hand-and-foot syndrome  1  6/97 (6.19%)  8 0/92 (0.00%)  0
Skin hypopigmentation  1  2/97 (2.06%)  3 0/92 (0.00%)  0
Vascular disorders     
Hypertension  1  7/97 (7.22%)  8 3/92 (3.26%)  3
Thrombosis  1  1/97 (1.03%)  1 1/92 (1.09%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Sunitinib Malate) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   87/97 (89.69%)      85/92 (92.39%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  9/97 (9.28%)  28 3/92 (3.26%)  6
Hemolysis  1  0/97 (0.00%)  0 2/92 (2.17%)  9
Cardiac disorders     
Left ventricular failure  1  1/97 (1.03%)  1 2/92 (2.17%)  4
Sinus bradycardia  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Ventricular tachycardia  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Ear and labyrinth disorders     
External ear inflammation  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  5/97 (5.15%)  11 5/92 (5.43%)  7
Gastrointestinal disorders     
Abdominal pain  1  2/97 (2.06%)  2 2/92 (2.17%)  3
Constipation  1  0/97 (0.00%)  0 2/92 (2.17%)  3
Diarrhea  1  44/97 (45.36%)  112 15/92 (16.30%)  37
Dyspepsia  1  1/97 (1.03%)  2 0/92 (0.00%)  0
Dysphagia  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Flatulence  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Gastritis  1  1/97 (1.03%)  2 0/92 (0.00%)  0
Mouth necrosis  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Mucositis oral  1  34/97 (35.05%)  71 7/92 (7.61%)  14
Nausea  1  37/97 (38.14%)  73 20/92 (21.74%)  42
Stomach pain  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Vomiting  1  5/97 (5.15%)  10 1/92 (1.09%)  1
General disorders     
Chest pain  1  3/97 (3.09%)  4 0/92 (0.00%)  0
Edema limbs  1  0/97 (0.00%)  0 4/92 (4.35%)  13
Fatigue  1  69/97 (71.13%)  218 67/92 (72.83%)  204
Fever  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Localized edema  1  1/97 (1.03%)  3 0/92 (0.00%)  0
Pain  1  2/97 (2.06%)  2 1/92 (1.09%)  1
Immune system disorders     
Immune system disorder  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Infections and infestations     
Pneumonia  1  0/97 (0.00%)  0 1/92 (1.09%)  1
Injury, poisoning and procedural complications     
Bruising  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Fracture  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Injury to superior vena cava  1  0/97 (0.00%)  0 1/92 (1.09%)  1
Investigations     
Alanine aminotransferase increased  1  1/97 (1.03%)  2 1/92 (1.09%)  1
Alkaline phosphatase increased  1  2/97 (2.06%)  3 0/92 (0.00%)  0
Amylase increased  1  1/97 (1.03%)  1 2/92 (2.17%)  4
Aspartate aminotransferase increased  1  1/97 (1.03%)  2 1/92 (1.09%)  1
CD4 lymphocytes decreased  1  2/97 (2.06%)  3 0/92 (0.00%)  0
Creatinine increased  1  1/97 (1.03%)  12 3/92 (3.26%)  15
Electrocardiogram QTc interval prolonged  1  1/97 (1.03%)  1 2/92 (2.17%)  4
Leukocyte count decreased  1  7/97 (7.22%)  23 2/92 (2.17%)  9
Lipase increased  1  1/97 (1.03%)  1 2/92 (2.17%)  4
Lymphocyte count decreased  1  3/97 (3.09%)  6 0/92 (0.00%)  0
Neutrophil count decreased  1  10/97 (10.31%)  23 1/92 (1.09%)  1
Platelet count decreased  1  13/97 (13.40%)  24 1/92 (1.09%)  2
Weight loss  1  4/97 (4.12%)  6 0/92 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  32/97 (32.99%)  83 19/92 (20.65%)  34
Blood glucose increased  1  1/97 (1.03%)  2 7/92 (7.61%)  31
Blood uric acid increased  1  1/97 (1.03%)  12 0/92 (0.00%)  0
Serum albumin decreased  1  3/97 (3.09%)  7 0/92 (0.00%)  0
Serum calcium increased  1  0/97 (0.00%)  0 1/92 (1.09%)  3
Serum glucose decreased  1  0/97 (0.00%)  0 2/92 (2.17%)  2
Serum magnesium decreased  1  1/97 (1.03%)  2 2/92 (2.17%)  7
Serum phosphate decreased  1  1/97 (1.03%)  1 1/92 (1.09%)  6
Serum potassium decreased  1  2/97 (2.06%)  3 1/92 (1.09%)  7
Serum sodium decreased  1  4/97 (4.12%)  8 1/92 (1.09%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/97 (2.06%)  2 1/92 (1.09%)  3
Back pain  1  3/97 (3.09%)  5 6/92 (6.52%)  12
Bone pain  1  1/97 (1.03%)  1 1/92 (1.09%)  1
Chest wall pain  1  1/97 (1.03%)  3 1/92 (1.09%)  1
Muscle weakness  1  1/97 (1.03%)  3 0/92 (0.00%)  0
Musculoskeletal disorder  1  0/97 (0.00%)  0 1/92 (1.09%)  1
Myalgia  1  1/97 (1.03%)  1 2/92 (2.17%)  3
Neck pain  1  1/97 (1.03%)  4 0/92 (0.00%)  0
Pain in extremity  1  3/97 (3.09%)  3 2/92 (2.17%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1  0/97 (0.00%)  0 1/92 (1.09%)  1
Nervous system disorders     
Accessory nerve disorder  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Depressed level of consciousness  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Dizziness  1  0/97 (0.00%)  0 2/92 (2.17%)  2
Dysgeusia  1  4/97 (4.12%)  8 1/92 (1.09%)  1
Headache  1  15/97 (15.46%)  27 12/92 (13.04%)  26
Ischemia cerebrovascular  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Peripheral motor neuropathy  1  1/97 (1.03%)  1 1/92 (1.09%)  2
Peripheral sensory neuropathy  1  6/97 (6.19%)  15 5/92 (5.43%)  7
Syncope  1  1/97 (1.03%)  1 1/92 (1.09%)  1
Psychiatric disorders     
Agitation  1  0/97 (0.00%)  0 1/92 (1.09%)  6
Anxiety  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Confusion  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Depression  1  1/97 (1.03%)  2 1/92 (1.09%)  1
Insomnia  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Renal and urinary disorders     
Renal failure  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/97 (5.15%)  7 5/92 (5.43%)  13
Dyspnea  1  5/97 (5.15%)  7 6/92 (6.52%)  23
Epistaxis  1  4/97 (4.12%)  6 0/92 (0.00%)  0
Mediastinal hemorrhage  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Pharyngolaryngeal pain  1  1/97 (1.03%)  1 0/92 (0.00%)  0
Pulmonary hemorrhage  1  1/97 (1.03%)  2 2/92 (2.17%)  2
Respiratory tract hemorrhage  1  0/97 (0.00%)  0 1/92 (1.09%)  3
Skin and subcutaneous tissue disorders     
Alopecia  1  1/97 (1.03%)  1 3/92 (3.26%)  4
Hand-and-foot syndrome  1  28/97 (28.87%)  83 8/92 (8.70%)  14
Rash desquamating  1  0/97 (0.00%)  0 1/92 (1.09%)  2
Skin hypopigmentation  1  9/97 (9.28%)  21 0/92 (0.00%)  0
Vascular disorders     
Hemorrhage  1  2/97 (2.06%)  2 0/92 (0.00%)  0
Hypertension  1  29/97 (29.90%)  81 13/92 (14.13%)  41
Thrombosis  1  0/97 (0.00%)  0 1/92 (1.09%)  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
Name/Title: Mark A. Socinski, M.D.
Organization: University of Pittsburgh
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00693992     History of Changes
Obsolete Identifiers: NCT01647087
Other Study ID Numbers: NCI-2009-00469
NCI-2009-00469 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000597649
CALGB 30607 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-30607 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: June 6, 2008
First Posted: June 9, 2008
Results First Submitted: December 8, 2016
Results First Posted: February 2, 2017
Last Update Posted: August 10, 2017