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Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT00110019
Recruitment Status : Completed
First Posted : May 4, 2005
Results First Posted : September 27, 2012
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Mucosal Melanoma
Recurrent Melanoma
Stage IIIA Skin Melanoma
Stage IIIB Skin Melanoma
Stage IIIC Skin Melanoma
Stage IV Skin Melanoma
Interventions Drug: Carboplatin
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Pharmacological Study
Other: Placebo
Drug: Sorafenib Tosylate
Enrollment 823
Recruitment Details This study was activated on June 23, 2005, and terminated on April 22, 2008 with the final accrual of 823 patients. Most of patients were accrued through Eastern Cooperative Oncology Group (ECOG), Cancer and Leukemia Group B (CALGB), and Southwest Oncology Group (SWOG). Other Clinical Trials Cooperative Groups also participated.
Pre-assignment Details  
Arm/Group Title Arm I (Carboplatin+Paclitaxel+Sorafenib) Arm II (Carboplatin+Paclitaxel)
Hide Arm/Group Description Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19. Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
Period Title: Overall Study
Started 410 413
Eligible 395 398
Treated 393 397
Completed 4 0
Not Completed 406 413
Reason Not Completed
Lack of Efficacy             253             285
Adverse Event             61             40
Death             13             15
Withdrawal by Subject             21             9
alternative therapy             5             1
complicating disease             1             1
symptom deterioration             13             16
Not start protocol therapy             17             16
other reasons             22             30
Arm/Group Title Arm I (Carboplatin+Paclitaxel+Sorafenib) Arm II (Carboplatin+Paclitaxel) Total
Hide Arm/Group Description Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19. Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19. Total of all reporting groups
Overall Number of Baseline Participants 410 413 823
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 410 participants 413 participants 823 participants
60
(19 to 86)
58
(18 to 84)
59
(18 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 410 participants 413 participants 823 participants
Female
140
  34.1%
162
  39.2%
302
  36.7%
Male
270
  65.9%
251
  60.8%
521
  63.3%
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival is defined as time from study entry to death from any cause. The comparison of overall survival was conducted in intention-to-treat population.
Time Frame Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population, n=823
Arm/Group Title Arm I (Carboplatin + Paclitaxel + Sorafenib) Arm II (Carboplatin + Paclitaxel+Placebo)
Hide Arm/Group Description:
Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
Overall Number of Participants Analyzed 410 413
Median (95% Confidence Interval)
Unit of Measure: months
11.1
(10.3 to 12.3)
11.3
(9.8 to 12.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Carboplatin + Paclitaxel + Sorafenib), Arm II (Carboplatin + Paclitaxel+Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.863
Comments [Not Specified]
Method Log Rank
Comments Stratified log rank test is used for overall survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.87 to 1.18
Estimation Comments Arm II is the reference group
2.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival was defined as time from study entry to disease progression or death from any cause, whichever occurred first. Patients without disease progression were censored at last date of assessment. Disease progression was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.
Time Frame Tumor response was assessed after every 2 cycles during cycle 1 through 10, and every 3 cycles after cycle 10. Survival was assessed every 3 months if patient is < 2 years from study entry, and every 6 months if 2-5 years from study entry.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population, n=821, two patients had no information about date of progression, and were excluded from the analysis
Arm/Group Title Arm I (Carboplatin + Paclitaxel + Sorafenib) Arm II (Carboplatin + Paclitaxel+Placebo)
Hide Arm/Group Description:
Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
Overall Number of Participants Analyzed 409 412
Median (95% Confidence Interval)
Unit of Measure: months
4.9
(4.5 to 5.6)
4.2
(3.4 to 4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Carboplatin + Paclitaxel + Sorafenib), Arm II (Carboplatin + Paclitaxel+Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments priori threshold for statistical significance: P<0.05
Method Log Rank
Comments Stratified log rank test is used for progression-free survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.78 to 1.03
Estimation Comments Arm II is the reference group
3.Secondary Outcome
Title Objective Response (Complete and Partial Response) Rate
Hide Description Tumor response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Objective response =complete response (CR) + partial response (PR). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of longest diameters.
Time Frame Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population, n=823
Arm/Group Title Arm I (Carboplatin + Paclitaxel + Sorafenib) Arm II (Carboplatin + Paclitaxel+Placebo)
Hide Arm/Group Description:
Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
Overall Number of Participants Analyzed 410 413
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion
0.205
(0.167 to 0.247)
0.182
(0.146 to 0.222)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Carboplatin + Paclitaxel + Sorafenib), Arm II (Carboplatin + Paclitaxel+Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.427
Comments priori threshold for statistical significance: P<0.05
Method Fisher Exact
Comments [Not Specified]
Time Frame assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Carboplatin + Paclitaxel + Sorafenib) Arm II (Carboplatin + Paclitaxel+Placebo)
Hide Arm/Group Description Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19. Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
All-Cause Mortality
Arm I (Carboplatin + Paclitaxel + Sorafenib) Arm II (Carboplatin + Paclitaxel+Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Carboplatin + Paclitaxel + Sorafenib) Arm II (Carboplatin + Paclitaxel+Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   332/393 (84.48%)   311/397 (78.34%) 
Blood and lymphatic system disorders     
Anemia  1  30/393 (7.63%)  28/397 (7.05%) 
Hemolysis  1  2/393 (0.51%)  0/397 (0.00%) 
Febrile neutropenia  1  24/393 (6.11%)  17/397 (4.28%) 
Lymph node, pain  1  1/393 (0.25%)  0/397 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  2/393 (0.51%)  2/397 (0.50%) 
Atrial flutter  1  2/393 (0.51%)  0/397 (0.00%) 
Sinus tachycardia  1  0/393 (0.00%)  1/397 (0.25%) 
Supraventricular tachycardia  1  1/393 (0.25%)  0/397 (0.00%) 
PVCs  1  1/393 (0.25%)  0/397 (0.00%) 
Cardiac-ischemia  1  4/393 (1.02%)  1/397 (0.25%) 
Left ventricular systolic dysfunction  1  1/393 (0.25%)  2/397 (0.50%) 
cardiac-other  1  0/393 (0.00%)  1/397 (0.25%) 
Cardiac/heart, pain  1  1/393 (0.25%)  1/397 (0.25%) 
Ear and labyrinth disorders     
Otitis, middle ear  1  1/393 (0.25%)  0/397 (0.00%) 
Tinnitus  1  1/393 (0.25%)  0/397 (0.00%) 
Eye disorders     
Cataract  1  1/393 (0.25%)  0/397 (0.00%) 
Retinal detachment  1  0/393 (0.00%)  1/397 (0.25%) 
Vision blurred  1  1/393 (0.25%)  0/397 (0.00%) 
Vision photophobia  1  1/393 (0.25%)  0/397 (0.00%) 
Gastrointestinal disorders     
Colitis  1  1/393 (0.25%)  0/397 (0.00%) 
Constipation  1  1/393 (0.25%)  3/397 (0.76%) 
Diarrhea w/o prior colostomy  1  29/393 (7.38%)  15/397 (3.78%) 
Distention/bloating, abdominal  1  0/393 (0.00%)  2/397 (0.50%) 
Dysphagia  1  1/393 (0.25%)  0/397 (0.00%) 
Esophagitis  1  0/393 (0.00%)  1/397 (0.25%) 
Dyspepsia  1  4/393 (1.02%)  0/397 (0.00%) 
Ileus  1  1/393 (0.25%)  1/397 (0.25%) 
Muco/stomatitis (symptom) oral  1  2/393 (0.51%)  1/397 (0.25%) 
Muco/stomatitis (symptom) stomach  1  5/393 (1.27%)  0/397 (0.00%) 
Nausea  1  16/393 (4.07%)  11/397 (2.77%) 
Obstruction, small bowel NOS  1  1/393 (0.25%)  2/397 (0.50%) 
Perforation, colon  1  2/393 (0.51%)  1/397 (0.25%) 
Ulcer, duodenum  1  1/393 (0.25%)  1/397 (0.25%) 
Vomiting  1  13/393 (3.31%)  11/397 (2.77%) 
Gastrointestinal disorder-other  1  2/393 (0.51%)  0/397 (0.00%) 
Abdomen, hemorrhage NOS  1  0/393 (0.00%)  1/397 (0.25%) 
Colon, hemorrhage  1  1/393 (0.25%)  1/397 (0.25%) 
Duodenum, hemorrhage  1  2/393 (0.51%)  1/397 (0.25%) 
Lower GI, hemorrhage NOS  1  1/393 (0.25%)  0/397 (0.00%) 
Stomach, hemorrhage  1  1/393 (0.25%)  0/397 (0.00%) 
Abdomen, pain  1  11/393 (2.80%)  3/397 (0.76%) 
General disorders     
Fatigue  1  63/393 (16.03%)  56/397 (14.11%) 
Fever w/o neutropenia  1  2/393 (0.51%)  0/397 (0.00%) 
Rigors/chills  1  0/393 (0.00%)  2/397 (0.50%) 
Death - multiorgan failure  1  1/393 (0.25%)  0/397 (0.00%) 
Death - sudden death  1  2/393 (0.51%)  1/397 (0.25%) 
Edema limb  1  1/393 (0.25%)  0/397 (0.00%) 
Chest/thoracic pain NOS  1  1/393 (0.25%)  2/397 (0.50%) 
Pain NOS  1  0/393 (0.00%)  1/397 (0.25%) 
Pericardium, pain  1  0/393 (0.00%)  1/397 (0.25%) 
Pain-other  1  2/393 (0.51%)  1/397 (0.25%) 
Immune system disorders     
Allergic reaction  1  20/393 (5.09%)  11/397 (2.77%) 
Infections and infestations     
Colitis, infectious (e.g. C.diff)  1  1/393 (0.25%)  0/397 (0.00%) 
Infection w/ gr304 neut, anal/perianal  1  0/393 (0.00%)  1/397 (0.25%) 
Infection w/ gr304 neut, bladder  1  0/393 (0.00%)  1/397 (0.25%) 
Infection w/ gr304 neut, bronchus  1  1/393 (0.25%)  0/397 (0.00%) 
Infection w/ gr304 neut, catheter relate  1  1/393 (0.25%)  0/397 (0.00%) 
Infection w/ gr304 neut, lung  1  2/393 (0.51%)  2/397 (0.50%) 
Infection w/ gr304 neut, oral cavity  1  0/393 (0.00%)  2/397 (0.50%) 
Infection w/ gr304 neut, pharynx  1  0/393 (0.00%)  2/397 (0.50%) 
Infection w/ gr304 neut, skin  1  2/393 (0.51%)  2/397 (0.50%) 
Infection w/ gr304 neut, upper airway  1  0/393 (0.00%)  1/397 (0.25%) 
Infection w/ gr304 neut, urinary tract  1  4/393 (1.02%)  1/397 (0.25%) 
Infection Gr002 neut, catheter  1  0/393 (0.00%)  1/397 (0.25%) 
Infection Gr002 neut, colon  1  0/393 (0.00%)  1/397 (0.25%) 
Infection Gr002 neut, foreign body  1  1/393 (0.25%)  0/397 (0.00%) 
Infection Gr002 neut, lung  1  3/393 (0.76%)  3/397 (0.76%) 
Infection Gr002 neut, pharynx  1  1/393 (0.25%)  0/397 (0.00%) 
Infection Gr002 neut, skin  1  2/393 (0.51%)  4/397 (1.01%) 
Infection Gr002 neut, soft tissue  1  0/393 (0.00%)  1/397 (0.25%) 
Infection Gr002 neut, urinary tract  1  1/393 (0.25%)  1/397 (0.25%) 
Infection Gr002 neut, wound  1  1/393 (0.25%)  0/397 (0.00%) 
Infection w/ unk ANC lung  1  0/393 (0.00%)  2/397 (0.50%) 
Infection w/ unk ANC mucosa  1  0/393 (0.00%)  1/397 (0.25%) 
Infection w/ unk ANC skin (cellulitis)  1  1/393 (0.25%)  0/397 (0.00%) 
Opportunistic infection  1  1/393 (0.25%)  1/397 (0.25%) 
Infection w/ gr304 neut, blood  1  9/393 (2.29%)  9/397 (2.27%) 
Infection Gr002 neut, blood  1  1/393 (0.25%)  1/397 (0.25%) 
Infection w/ unk ANC blood  1  0/393 (0.00%)  1/397 (0.25%) 
Infection- other  1  2/393 (0.51%)  1/397 (0.25%) 
Investigations     
Leukopenia  1  108/393 (27.48%)  91/397 (22.92%) 
Lymphopenia  1  21/393 (5.34%)  17/397 (4.28%) 
Neutropenia  1  192/393 (48.85%)  195/397 (49.12%) 
Thrombocytopenia  1  92/393 (23.41%)  35/397 (8.82%) 
Weight loss  1  2/393 (0.51%)  1/397 (0.25%) 
INR increased  1  1/393 (0.25%)  0/397 (0.00%) 
activated partial thromboplastin time (PTT)  1  1/393 (0.25%)  0/397 (0.00%) 
Alkaline phosphatase increased  1  5/393 (1.27%)  3/397 (0.76%) 
ALT, SGPT  1  5/393 (1.27%)  2/397 (0.50%) 
Serum amylase increased  1  4/393 (1.02%)  2/397 (0.50%) 
AST, SGOT  1  3/393 (0.76%)  2/397 (0.50%) 
Blood bilirubin increased  1  3/393 (0.76%)  0/397 (0.00%) 
Creatinine increased  1  3/393 (0.76%)  2/397 (0.50%) 
GGT increased  1  1/393 (0.25%)  1/397 (0.25%) 
Metabolic/Laboratory-other  1  2/393 (0.51%)  2/397 (0.50%) 
Lipase increased  1  14/393 (3.56%)  6/397 (1.51%) 
Metabolism and nutrition disorders     
Anorexia  1  21/393 (5.34%)  9/397 (2.27%) 
Dehydration  1  21/393 (5.34%)  19/397 (4.79%) 
Hypoalbuminemia  1  2/393 (0.51%)  4/397 (1.01%) 
Alkalosis  1  0/393 (0.00%)  1/397 (0.25%) 
Hypercalcemia  1  0/393 (0.00%)  1/397 (0.25%) 
Hypocalcemia  1  1/393 (0.25%)  3/397 (0.76%) 
Hyperglycemia  1  17/393 (4.33%)  19/397 (4.79%) 
Hypomagnesemia  1  2/393 (0.51%)  2/397 (0.50%) 
Hypophosphatemia  1  6/393 (1.53%)  2/397 (0.50%) 
Hyperkalemia  1  1/393 (0.25%)  1/397 (0.25%) 
Hypokalemia  1  12/393 (3.05%)  11/397 (2.77%) 
Hypernatremia  1  1/393 (0.25%)  0/397 (0.00%) 
Hypertriglyceridemia  1  0/393 (0.00%)  1/397 (0.25%) 
Hypoglycemia  1  2/393 (0.51%)  1/397 (0.25%) 
Hypermagnesemia  1  1/393 (0.25%)  2/397 (0.50%) 
Hyponatremia  1  21/393 (5.34%)  9/397 (2.27%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/393 (0.25%)  0/397 (0.00%) 
Joint-function  1  1/393 (0.25%)  0/397 (0.00%) 
Nonneuropathic lower extr muscle  1  5/393 (1.27%)  0/397 (0.00%) 
Nonneuropathic upper extr muscle  1  0/393 (0.00%)  1/397 (0.25%) 
Nonneuropathic generalized weakness  1  7/393 (1.78%)  3/397 (0.76%) 
Bone, pain  1  2/393 (0.51%)  1/397 (0.25%) 
Chest wall, pain  1  3/393 (0.76%)  0/397 (0.00%) 
Extremity limb, pain  1  6/393 (1.53%)  0/397 (0.00%) 
Joint, pain  1  14/393 (3.56%)  14/397 (3.53%) 
Muscle, pain  1  18/393 (4.58%)  22/397 (5.54%) 
Nervous system disorders     
CNS, hemorrhage  1  1/393 (0.25%)  1/397 (0.25%) 
Ataxia  1  1/393 (0.25%)  1/397 (0.25%) 
CNS cerebrovascular ischemia  1  1/393 (0.25%)  1/397 (0.25%) 
Cognitive disturbance  1  1/393 (0.25%)  0/397 (0.00%) 
Dizziness  1  2/393 (0.51%)  8/397 (2.02%) 
Encephalopathy  1  1/393 (0.25%)  1/397 (0.25%) 
Neuropathy- motor  1  12/393 (3.05%)  10/397 (2.52%) 
Neuropathy- sensory  1  81/393 (20.61%)  59/397 (14.86%) 
Seizure  1  0/393 (0.00%)  1/397 (0.25%) 
Syncope  1  2/393 (0.51%)  3/397 (0.76%) 
Head/headache  1  2/393 (0.51%)  2/397 (0.50%) 
Neuropathic, pain  1  1/393 (0.25%)  0/397 (0.00%) 
Psychiatric disorders     
Insomnia  1  3/393 (0.76%)  3/397 (0.76%) 
Confusion  1  3/393 (0.76%)  1/397 (0.25%) 
Agitation  1  1/393 (0.25%)  0/397 (0.00%) 
Anxiety  1  0/393 (0.00%)  3/397 (0.76%) 
Depression  1  0/393 (0.00%)  1/397 (0.25%) 
Personality  1  0/393 (0.00%)  1/397 (0.25%) 
Renal and urinary disorders     
Kidney, hemorrhage  1  1/393 (0.25%)  0/397 (0.00%) 
Renal failure  1  4/393 (1.02%)  6/397 (1.51%) 
Respiratory, thoracic and mediastinal disorders     
Nose, hemorrhage  1  1/393 (0.25%)  0/397 (0.00%) 
Pleura, pain  1  1/393 (0.25%)  0/397 (0.00%) 
Throat/pharynx/larynx, pain  1  1/393 (0.25%)  0/397 (0.00%) 
ARDS  1  0/393 (0.00%)  1/397 (0.25%) 
Dyspnea  1  5/393 (1.27%)  7/397 (1.76%) 
Hiccoughs  1  2/393 (0.51%)  1/397 (0.25%) 
Hypoxia  1  3/393 (0.76%)  1/397 (0.25%) 
Pleural effusion (non-malignant)  1  0/393 (0.00%)  1/397 (0.25%) 
Pneumonitis/pulmonary infiltrates  1  1/393 (0.25%)  0/397 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  3/393 (0.76%)  1/397 (0.25%) 
Pruritus/itching  1  13/393 (3.31%)  2/397 (0.50%) 
Rash/desquamation  1  58/393 (14.76%)  8/397 (2.02%) 
Rash: acne/acneiform  1  3/393 (0.76%)  0/397 (0.00%) 
Hand-foot reaction  1  47/393 (11.96%)  1/397 (0.25%) 
Ulceration  1  1/393 (0.25%)  0/397 (0.00%) 
Skin, pain  1  1/393 (0.25%)  0/397 (0.00%) 
Vascular disorders     
Hypertension  1  18/393 (4.58%)  5/397 (1.26%) 
Hypotension  1  11/393 (2.80%)  5/397 (1.26%) 
Hot flashes  1  0/393 (0.00%)  1/397 (0.25%) 
Hematoma  1  1/393 (0.25%)  0/397 (0.00%) 
Hemorrhage-other  1  1/393 (0.25%)  0/397 (0.00%) 
Thrombosis/thrombus/embolism  1  4/393 (1.02%)  8/397 (2.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Carboplatin + Paclitaxel + Sorafenib) Arm II (Carboplatin + Paclitaxel+Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   385/393 (97.96%)   384/397 (96.73%) 
Blood and lymphatic system disorders     
Anemia  1  191/393 (48.60%)  195/397 (49.12%) 
Gastrointestinal disorders     
Constipation  1  101/393 (25.70%)  86/397 (21.66%) 
Diarrhea w/o prior colostomy  1  200/393 (50.89%)  113/397 (28.46%) 
Dyspepsia  1  36/393 (9.16%)  35/397 (8.82%) 
Muco/stomatitis (symptom) stomach  1  84/393 (21.37%)  44/397 (11.08%) 
Nausea  1  206/393 (52.42%)  230/397 (57.93%) 
Taste disturbance  1  57/393 (14.50%)  54/397 (13.60%) 
Vomiting  1  104/393 (26.46%)  117/397 (29.47%) 
Abdomen, pain  1  30/393 (7.63%)  21/397 (5.29%) 
General disorders     
Fatigue  1  311/393 (79.13%)  296/397 (74.56%) 
Fever w/o neutropenia  1  19/393 (4.83%)  25/397 (6.30%) 
Rigors/chills  1  34/393 (8.65%)  21/397 (5.29%) 
Sweating  1  23/393 (5.85%)  12/397 (3.02%) 
Edema limb  1  35/393 (8.91%)  31/397 (7.81%) 
Investigations     
Leukopenia  1  135/393 (34.35%)  146/397 (36.78%) 
Lymphopenia  1  38/393 (9.67%)  29/397 (7.30%) 
Neutropenia  1  101/393 (25.70%)  117/397 (29.47%) 
Thrombocytopenia  1  182/393 (46.31%)  131/397 (33.00%) 
Weight loss  1  62/393 (15.78%)  25/397 (6.30%) 
Alkaline phosphatase increased  1  46/393 (11.70%)  29/397 (7.30%) 
Alanine aminotransferase (ALT, SGPT)  1  48/393 (12.21%)  33/397 (8.31%) 
Aspartate aminotransferase (AST, SGOT)  1  56/393 (14.25%)  29/397 (7.30%) 
Lipase increased  1  27/393 (6.87%)  14/397 (3.53%) 
Creatinine increased  1  21/393 (5.34%)  26/397 (6.55%) 
Metabolism and nutrition disorders     
Anorexia  1  137/393 (34.86%)  118/397 (29.72%) 
Dehydration  1  23/393 (5.85%)  20/397 (5.04%) 
Hypoalbuminemia  1  36/393 (9.16%)  27/397 (6.80%) 
Hyperglycemia  1  58/393 (14.76%)  44/397 (11.08%) 
Hypomagnesemia  1  33/393 (8.40%)  29/397 (7.30%) 
Hypokalemia  1  49/393 (12.47%)  20/397 (5.04%) 
Hyponatremia  1  51/393 (12.98%)  37/397 (9.32%) 
Metabolic/Laboratory-other  1  26/393 (6.62%)  14/397 (3.53%) 
Hypocalcemia  1  37/393 (9.41%)  17/397 (4.28%) 
Musculoskeletal and connective tissue disorders     
Extremity-limb, pain  1  23/393 (5.85%)  19/397 (4.79%) 
Joint, pain  1  157/393 (39.95%)  151/397 (38.04%) 
Muscle, pain  1  158/393 (40.20%)  182/397 (45.84%) 
Nervous system disorders     
Dizziness  1  52/393 (13.23%)  45/397 (11.34%) 
Neuropathy-sensory  1  262/393 (66.67%)  265/397 (66.75%) 
Head/headache  1  46/393 (11.70%)  34/397 (8.56%) 
Psychiatric disorders     
Insomnia  1  47/393 (11.96%)  39/397 (9.82%) 
Respiratory, thoracic and mediastinal disorders     
Nose, hemorrhage  1  21/393 (5.34%)  5/397 (1.26%) 
Cough  1  22/393 (5.60%)  18/397 (4.53%) 
Dyspnea  1  65/393 (16.54%)  54/397 (13.60%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  38/393 (9.67%)  10/397 (2.52%) 
Flushing  1  21/393 (5.34%)  12/397 (3.02%) 
Alopecia  1  202/393 (51.40%)  209/397 (52.64%) 
Pruritus/itching  1  110/393 (27.99%)  59/397 (14.86%) 
Rash/desquamation  1  198/393 (50.38%)  105/397 (26.45%) 
Hand-foot reaction  1  119/393 (30.28%)  28/397 (7.05%) 
Skin-other  1  20/393 (5.09%)  7/397 (1.76%) 
Vascular disorders     
Hypertension  1  87/393 (22.14%)  38/397 (9.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00110019     History of Changes
Other Study ID Numbers: NCI-2012-02978
NCI-2012-02978 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E2603 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
E2603 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: May 3, 2005
First Posted: May 4, 2005
Results First Submitted: August 28, 2012
Results First Posted: September 27, 2012
Last Update Posted: October 19, 2015