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Combination Chemotherapy With or Without Vismodegib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer

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ClinicalTrials.gov Identifier: NCT00982592
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
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 Adenocarcinoma of the Gastroesophageal Junction
Adenocarcinoma of the Stomach
Recurrent Gastric Cancer
Stage IIIA Gastric Cancer
Stage IIIB Gastric Cancer
Stage IIIC Gastric Cancer
Stage IV Gastric Cancer
Interventions Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Other: placebo
Drug: vismodegib
Other: laboratory biomarker analysis
Enrollment 124

Recruitment Details From October 2009 to February 2012, 124 patients were enrolled from multi sites to this study.
Pre-assignment Details  
Arm/Group Title Arm I (FOLFOX Regimen and Placebo) Arm II (FOLFOX Regimen and Vismodegib)
Hide Arm/Group Description Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression. Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Period Title: Overall Study
Started 64 60
Treatment Received 63 52
Completed 33 [1] 27 [1]
Not Completed 31 33
[1]
patients who were off treatment due to disease progression
Arm/Group Title Arm I (FOLFOX Regimen and Placebo) Arm II (FOLFOX Regimen and Vismodegib) Total
Hide Arm/Group Description Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression. Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression. Total of all reporting groups
Overall Number of Baseline Participants 64 60 124
Hide Baseline Analysis Population Description
all the patients enrolled to the study
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 64 participants 60 participants 124 participants
61.5
(25 to 77)
57.5
(29 to 74)
60
(25 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 60 participants 124 participants
Female
11
  17.2%
21
  35.0%
32
  25.8%
Male
53
  82.8%
39
  65.0%
92
  74.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants 60 participants 124 participants
Caucasian 50 42 92
Asian 3 6 9
African American 6 4 10
Hispanic 4 8 12
Nor reported 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 64 participants 60 participants 124 participants
64 60 124
1.Primary Outcome
Title Median Progression-free Survival (PFS)
Hide Description PFS is defined as the time from randomization until objective tumor progression or death from any cause and is evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time Frame up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Arm I (FOLFOX Regimen and Placebo) Arm II (FOLFOX Regimen and Vismodegib)
Hide Arm/Group Description:
Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 64 60
Median (95% Confidence Interval)
Unit of Measure: months
8.77
(5.65 to 10.61)
8.35
(5.55 to 10.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (FOLFOX Regimen and Placebo), Arm II (FOLFOX Regimen and Vismodegib)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.874
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.70 to 1.54
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Objective Response Rate
Hide Description Defined as the percentage of the patients who had complete response (CR) or partial response (PR) per RECIST 1.1.
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Arm I (FOLFOX Regimen and Placebo) Arm II (FOLFOX Regimen and Vismodegib)
Hide Arm/Group Description:
Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 64 60
Measure Type: Number
Unit of Measure: percentage of patients
44 37
3.Secondary Outcome
Title Overall Survival
Hide Description Defined as time from randomization day until death from any cause.
Time Frame up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Arm I (FOLFOX Regimen and Placebo) Arm II (FOLFOX Regimen and Vismodegib)
Hide Arm/Group Description:
Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 64 60
Median (95% Confidence Interval)
Unit of Measure: months
15.38
(12.32 to 19.52)
12.12
(10.28 to 17.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (FOLFOX Regimen and Placebo), Arm II (FOLFOX Regimen and Vismodegib)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.253
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.83 to 2.05
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Incidence of Toxicities (Grade 3 and Higher)
Hide Description Defined as percentage of patients who experienced a toxicity with grade 3 or higher related to the protocol therapy. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All the patients who started the treatment.
Arm/Group Title Arm I (FOLFOX Regimen and Placebo) Arm II (FOLFOX Regimen and Vismodegib)
Hide Arm/Group Description:
Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 63 52
Measure Type: Number
Unit of Measure: percentage of patients
Neuropathy (sensory) 13 19
Fatigue 10 15
Thrombosis 11 14
Nausea 8 8
Hemorrhage_GI 11 8
Vomiting 6 8
Dehydration 6 8
Neutropenia 32 50
Febrile neutropenia 5 2
Anemia 10 10
Thrombocytopenia 0 6
Hypokalemia 5 10
Hyperglycemia 10 4
Hyponatremia 10 2
5.Secondary Outcome
Title Incidence of Toxicities (grades1 and 2)
Hide Description Defined as percentage of patients who experienced a toxicity with grade 1 or 2 (worst grade) related to the protocol therapy. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All the patients who started the treatment.
Arm/Group Title Arm I (FOLFOX Regimen and Placebo) Arm II (FOLFOX Regimen and Vismodegib)
Hide Arm/Group Description:
Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 63 52
Measure Type: Number
Unit of Measure: percentage of patients
Neuropathy (sensory) 56 62
Fatigue 54 73
Diarrhea 48 40
Nausea 54 71
Dysguesia 16 42
Vomiting 38 37
Anorexia 41 35
Weight loss 30 29
Leukocytes 57 46
Anemia 51 60
Thrombocytopenia 57 56
Hypoalbuminemia 52 40
Hyperglycemia 41 37
Elevated AST 29 46
Time Frame Up to 4 years.
Adverse Event Reporting Description All the adverse events above the reporting threshold are reported here regardless of attributions. Sixty three patients on the placebo arm and 52 on the Vismodegib arm started treatments; 1 and 8 patients did not receive treatments, respectively.
 
Arm/Group Title Arm I (FOLFOX Regimen and Placebo) Arm II (FOLFOX Regimen and Vismodegib)
Hide Arm/Group Description Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression. Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
All-Cause Mortality
Arm I (FOLFOX Regimen and Placebo) Arm II (FOLFOX Regimen and Vismodegib)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (FOLFOX Regimen and Placebo) Arm II (FOLFOX Regimen and Vismodegib)
Affected / at Risk (%) Affected / at Risk (%)
Total   24/63 (38.10%)   20/52 (38.46%) 
Blood and lymphatic system disorders     
Hemoglobin  1  1/63 (1.59%)  0/52 (0.00%) 
Leukocytes (total WBC)  1  0/63 (0.00%)  2/52 (3.85%) 
Lymphopenia  1  0/63 (0.00%)  1/52 (1.92%) 
Neutrophils/granulocytes (ANC/AGC)  1  1/63 (1.59%)  4/52 (7.69%) 
Cardiac disorders     
Cardiac General - Other (Specify, __)SINUS BRADYCARDIA  1  0/63 (0.00%)  1/52 (1.92%) 
Cardiac ischemia/infarction  1  1/63 (1.59%)  0/52 (0.00%) 
Hypotension  1  1/63 (1.59%)  0/52 (0.00%) 
Gastrointestinal disorders     
Ascites (non-malignant)  1  1/63 (1.59%)  0/52 (0.00%) 
Dehydration  1  3/63 (4.76%)  3/52 (5.77%) 
Diarrhea  1  3/63 (4.76%)  1/52 (1.92%) 
Distension/bloating, abdominal  1  1/63 (1.59%)  0/52 (0.00%) 
Dysphagia (difficulty swallowing)  1  1/63 (1.59%)  2/52 (3.85%) 
Esophagitis  1  1/63 (1.59%)  0/52 (0.00%) 
Gastrointestinal - Other (Specify, __)MALIGNANT ASCITES  1  0/63 (0.00%)  1/52 (1.92%) 
Gastrointestinal - Other (Specify, __)GASTRIC PERFORATION  1  1/63 (1.59%)  0/52 (0.00%) 
Hemorrhage, GI: Esophagus  1  1/63 (1.59%)  0/52 (0.00%) 
Hemorrhage, GI: Stomach  1  1/63 (1.59%)  2/52 (3.85%) 
Hemorrhage, GI: Lower GI NOS  1  1/63 (1.59%)  0/52 (0.00%) 
Nausea  1  1/63 (1.59%)  3/52 (5.77%) 
Obstruction, GI: Colon  1  1/63 (1.59%)  0/52 (0.00%) 
Pain: Abdomen NOS  1  1/63 (1.59%)  3/52 (5.77%) 
Pain: Intestine  1  1/63 (1.59%)  0/52 (0.00%) 
Stricture/stenosis (including anastomotic), GI: Stomach  1  0/63 (0.00%)  1/52 (1.92%) 
Vomiting  1  3/63 (4.76%)  2/52 (3.85%) 
General disorders     
Death not associated with CTCAE term: Death NOS  1  3/63 (4.76%)  2/52 (3.85%) 
Fatigue (asthenia, lethargy, malaise)  1  1/63 (1.59%)  3/52 (5.77%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  0/63 (0.00%)  3/52 (5.77%) 
Hemorrhage, GI: Upper GI NOS  1  3/63 (4.76%)  0/52 (0.00%) 
Hepatobiliary disorders     
Hepatobiliary/Pancreas - Other (Specify, __)VENO-OCCLUSIVE DISEASE  1  1/63 (1.59%)  0/52 (0.00%) 
Infections and infestations     
Febrile neutropenia  1  2/63 (3.17%)  1/52 (1.92%) 
Infection - Other (Specify, __)PLEURAL ABSCESS  1  1/63 (1.59%)  0/52 (0.00%) 
Infection - Other (Specify, __)THRUSH  1  1/63 (1.59%)  0/52 (0.00%) 
Infection with Grade 3 or 4 neutrophils: Lung (pneumonia)  1  1/63 (1.59%)  0/52 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Catheter-related  1  1/63 (1.59%)  0/52 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Kidney  1  1/63 (1.59%)  0/52 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Lung (pneumonia)  1  2/63 (3.17%)  0/52 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound  1  1/63 (1.59%)  0/52 (0.00%) 
Infection with unknown ANC: Lung (pneumonia)  1  1/63 (1.59%)  0/52 (0.00%) 
Infection with unknown ANC: Pleura (empyema)  1  1/63 (1.59%)  0/52 (0.00%) 
Metabolism and nutrition disorders     
Albumin, serum-low (hypoalbuminemia)  1  0/63 (0.00%)  1/52 (1.92%) 
Sodium, serum-low (hyponatremia)  1  1/63 (1.59%)  0/52 (0.00%) 
Potassium, serum-low (hypokalemia)  1  0/63 (0.00%)  1/52 (1.92%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower  1  0/63 (0.00%)  1/52 (1.92%) 
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-upper  1  1/63 (1.59%)  0/52 (0.00%) 
Musculoskeletal/Soft Tissue - Other (Specify, __)KNEE PAIN AND SWELLING  1  0/63 (0.00%)  1/52 (1.92%) 
Pain: Chest wall  1  1/63 (1.59%)  0/52 (0.00%) 
Pain: Joint  1  1/63 (1.59%)  0/52 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Death not associated with CTCAE term: Disease progression NOS  1  0/63 (0.00%)  3/52 (5.77%) 
Pain: Tumor pain  1  1/63 (1.59%)  0/52 (0.00%) 
Nervous system disorders     
CNS cerebrovascular ischemia  1  0/63 (0.00%)  1/52 (1.92%) 
Mental status  1  0/63 (0.00%)  1/52 (1.92%) 
Neurology - Other (Specify, __)DECREASED RESPONSIVENESS AFTER SEDATION  1  1/63 (1.59%)  0/52 (0.00%) 
Neuropathy: sensory  1  1/63 (1.59%)  0/52 (0.00%) 
Neuropathy: motor  1  0/63 (0.00%)  1/52 (1.92%) 
Syncope (fainting)  1  1/63 (1.59%)  1/52 (1.92%) 
Renal and urinary disorders     
Obstruction, GU: Ureter  1  0/63 (0.00%)  1/52 (1.92%) 
Renal failure  1  0/63 (0.00%)  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea (shortness of breath)  1  5/63 (7.94%)  1/52 (1.92%) 
Pleural effusion (non-malignant)  1  1/63 (1.59%)  0/52 (0.00%) 
Pneumonitis/pulmonary infiltrates  1  1/63 (1.59%)  0/52 (0.00%) 
Pulmonary/Upper Respiratory - Other (Specify, __)MALIGNANT PLEURAL EFFUSION  1  1/63 (1.59%)  0/52 (0.00%) 
Vascular disorders     
Portal vein flow  1  1/63 (1.59%)  0/52 (0.00%) 
Thrombosis/thrombus/embolism  1  5/63 (7.94%)  2/52 (3.85%) 
Thrombosis/embolism (vascular access-related)  1  2/63 (3.17%)  0/52 (0.00%) 
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 2%
Arm I (FOLFOX Regimen and Placebo) Arm II (FOLFOX Regimen and Vismodegib)
Affected / at Risk (%) Affected / at Risk (%)
Total   63/63 (100.00%)   52/52 (100.00%) 
Blood and lymphatic system disorders     
Blood/Bone Marrow - Other (Specify, __)LOW EOSINOPHILS  1  3/63 (4.76%)  0/52 (0.00%) 
Blood/Bone Marrow - Other (Specify, __)HIGH LYMPHOCYTES  1  3/63 (4.76%)  0/52 (0.00%) 
Blood/Bone Marrow - Other (Specify, __)LOW EOSINOPHILS  1  2/63 (3.17%)  0/52 (0.00%) 
Blood/Bone Marrow - Other (Specify, __)MONOCYTOSIS  1  4/63 (6.35%)  2/52 (3.85%) 
Edema:limb  1  9/63 (14.29%)  4/52 (7.69%) 
Hemoglobin  1  37/63 (58.73%)  34/52 (65.38%) 
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)  1  3/63 (4.76%)  2/52 (3.85%) 
Leukocytes (total WBC)  1  40/63 (63.49%)  29/52 (55.77%) 
Lymphopenia  1  23/63 (36.51%)  16/52 (30.77%) 
Neutrophils/granulocytes (ANC/AGC)  1  28/63 (44.44%)  33/52 (63.46%) 
Platelets  1  36/63 (57.14%)  32/52 (61.54%) 
Cardiac disorders     
Hypertension  1  4/63 (6.35%)  0/52 (0.00%) 
Hypotension  1  3/63 (4.76%)  0/52 (0.00%) 
Palpitations  1  3/63 (4.76%)  0/52 (0.00%) 
Eye disorders     
Vision-blurred vision  1  5/63 (7.94%)  2/52 (3.85%) 
Gastrointestinal disorders     
Anorexia  1  27/63 (42.86%)  20/52 (38.46%) 
Ascites (non-malignant)  1  3/63 (4.76%)  0/52 (0.00%) 
Constipation  1  24/63 (38.10%)  22/52 (42.31%) 
Dehydration  1  4/63 (6.35%)  6/52 (11.54%) 
Diarrhea  1  32/63 (50.79%)  21/52 (40.38%) 
Distension/bloating, abdominal  1  0/63 (0.00%)  5/52 (9.62%) 
Dry mouth/salivary gland (xerostomia)  1  3/63 (4.76%)  2/52 (3.85%) 
Dysphagia (difficulty swallowing)  1  11/63 (17.46%)  12/52 (23.08%) 
Flatulence  1  2/63 (3.17%)  0/52 (0.00%) 
Gastritis (including bile reflux gastritis)  1  2/63 (3.17%)  2/52 (3.85%) 
Heartburn/dyspepsia  1  4/63 (6.35%)  10/52 (19.23%) 
Hemorrhage, GI: Esophagus  1  0/63 (0.00%)  2/52 (3.85%) 
Hemorrhage, GI: Rectum  1  2/63 (3.17%)  0/52 (0.00%) 
Mucositis/stomatitis (clinical exam): Oral cavity  1  12/63 (19.05%)  7/52 (13.46%) 
Mucositis/stomatitis (functional/symptomatic): Oral cavity  1  9/63 (14.29%)  4/52 (7.69%) 
Nausea  1  40/63 (63.49%)  41/52 (78.85%) 
Pain: Abdomen NOS  1  23/63 (36.51%)  4/52 (7.69%) 
Pain: Esophagus  1  2/63 (3.17%)  0/52 (0.00%) 
Pain: Oral cavity  1  6/63 (9.52%)  2/52 (3.85%) 
Pain: Stomach  1  3/63 (4.76%)  2/52 (3.85%) 
Taste alteration (dysgeusia)  1  10/63 (15.87%)  24/52 (46.15%) 
Vomiting  1  28/63 (44.44%)  22/52 (42.31%) 
General disorders     
Fatigue (asthenia, lethargy, malaise)  1  44/63 (69.84%)  44/52 (84.62%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  7/63 (11.11%)  5/52 (9.62%) 
Flu-like syndrome  1  3/63 (4.76%)  0/52 (0.00%) 
Insomnia  1  5/63 (7.94%)  11/52 (21.15%) 
Pain: Chest/thorax NOS  1  6/63 (9.52%)  4/52 (7.69%) 
Rigors/chills  1  3/63 (4.76%)  6/52 (11.54%) 
Weight loss  1  19/63 (30.16%)  15/52 (28.85%) 
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  4/63 (6.35%)  2/52 (3.85%) 
Infections and infestations     
Infection - Other (Specify, __)THRUSH  1  4/63 (6.35%)  3/52 (5.77%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: External ear (otitis externa)  1  2/63 (3.17%)  0/52 (0.00%) 
Infection with unknown ANC: Urinary tract NOS  1  0/63 (0.00%)  2/52 (3.85%) 
Investigations     
INR (International Normalized Ratio of prothrombin time)  1  0/63 (0.00%)  2/52 (3.85%) 
Metabolism and nutrition disorders     
Albumin, serum-low (hypoalbuminemia)  1  35/63 (55.56%)  21/52 (40.38%) 
Alkaline phosphatase  1  22/63 (34.92%)  22/52 (42.31%) 
ALT, SGPT (serum glutamic pyruvic transaminase)  1  11/63 (17.46%)  23/52 (44.23%) 
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  20/63 (31.75%)  23/52 (44.23%) 
Bicarbonate, serum-low  1  2/63 (3.17%)  7/52 (13.46%) 
Bilirubin (hyperbilirubinemia)  1  8/63 (12.70%)  4/52 (7.69%) 
Calcium, serum-low (hypocalcemia)  1  19/63 (30.16%)  9/52 (17.31%) 
Creatinine  1  3/63 (4.76%)  4/52 (7.69%) 
Glucose, serum-high (hyperglycemia)  1  31/63 (49.21%)  22/52 (42.31%) 
Glucose, serum-low (hypoglycemia)  1  3/63 (4.76%)  5/52 (9.62%) 
Magnesium, serum-low (hypomagnesemia)  1  0/63 (0.00%)  4/52 (7.69%) 
Metabolic/Laboratory - Other (Specify, __)LOW CO2  1  2/63 (3.17%)  0/52 (0.00%) 
Metabolic/Laboratory - Other (Specify, __)TOTAL PROTEIN DECREASED  1  4/63 (6.35%)  0/52 (0.00%) 
Phosphate, serum-low (hypophosphatemia)  1  5/63 (7.94%)  3/52 (5.77%) 
Potassium, serum-high (hyperkalemia)  1  6/63 (9.52%)  0/52 (0.00%) 
Potassium, serum-low (hypokalemia)  1  22/63 (34.92%)  12/52 (23.08%) 
Sodium, serum-high (hypernatremia)  1  2/63 (3.17%)  0/52 (0.00%) 
Sodium, serum-low (hyponatremia)  1  22/63 (34.92%)  17/52 (32.69%) 
Musculoskeletal and connective tissue disorders     
Fracture  1  0/63 (0.00%)  2/52 (3.85%) 
Muscle weakness, generalized or specific area (not due to neuropathy): Whole body/generalized  1  3/63 (4.76%)  0/52 (0.00%) 
Pain - Other (Specify, __)GROIN  1  2/63 (3.17%)  0/52 (0.00%) 
Pain - Other (Specify, __)RIB  1  2/63 (3.17%)  0/52 (0.00%) 
Pain: Back  1  9/63 (14.29%)  4/52 (7.69%) 
Pain: Bone  1  2/63 (3.17%)  0/52 (0.00%) 
Pain: Chest wall  1  3/63 (4.76%)  0/52 (0.00%) 
Pain: Extremity-limb  1  9/63 (14.29%)  7/52 (13.46%) 
Pain: Joint  1  6/63 (9.52%)  6/52 (11.54%) 
Pain: Muscle  1  2/63 (3.17%)  2/52 (3.85%) 
Pain: Neck  1  2/63 (3.17%)  5/52 (9.62%) 
Nervous system disorders     
Dizziness  1  13/63 (20.63%)  12/52 (23.08%) 
Memory impairment  1  2/63 (3.17%)  0/52 (0.00%) 
Mood alteration: Anxiety  1  4/63 (6.35%)  3/52 (5.77%) 
Mood alteration: Depression  1  4/63 (6.35%)  6/52 (11.54%) 
Neurology - Other (Specify, __)COLD SENSITIVITY  1  5/63 (7.94%)  4/52 (7.69%) 
Neuropathy: motor  1  4/63 (6.35%)  3/52 (5.77%) 
Neuropathy: sensory  1  42/63 (66.67%)  42/52 (80.77%) 
Pain: Head/headache  1  6/63 (9.52%)  8/52 (15.38%) 
Tremor  1  0/63 (0.00%)  2/52 (3.85%) 
Renal and urinary disorders     
Urinary frequency/urgency  1  3/63 (4.76%)  3/52 (5.77%) 
Urinary retention (including neurogenic bladder)  1  3/63 (4.76%)  0/52 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  0/63 (0.00%)  5/52 (9.62%) 
Cough  1  13/63 (20.63%)  9/52 (17.31%) 
Dyspnea (shortness of breath)  1  13/63 (20.63%)  8/52 (15.38%) 
Hemorrhage, pulmonary/upper respiratory: Nose  1  8/63 (12.70%)  5/52 (9.62%) 
Hiccoughs (hiccups, singultus)  1  2/63 (3.17%)  0/52 (0.00%) 
Nasal cavity/paranasal sinus reactions  1  2/63 (3.17%)  0/52 (0.00%) 
Pain: Throat/pharynx/larynx  1  6/63 (9.52%)  0/52 (0.00%) 
Pulmonary/Upper Respiratory - Other (Specify, __)RUNNY NOSE  1  2/63 (3.17%)  0/52 (0.00%) 
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)  1  2/63 (3.17%)  2/52 (3.85%) 
Skin and subcutaneous tissue disorders     
Cheilitis  1  2/63 (3.17%)  0/52 (0.00%) 
Dry skin  1  7/63 (11.11%)  3/52 (5.77%) 
Hair loss/alopecia (scalp or body)  1  7/63 (11.11%)  9/52 (17.31%) 
Photosensitivity  1  0/63 (0.00%)  2/52 (3.85%) 
Pruritus/itching  1  2/63 (3.17%)  2/52 (3.85%) 
Rash/desquamation  1  6/63 (9.52%)  6/52 (11.54%) 
Rash: acne/acneiform  1  2/63 (3.17%)  2/52 (3.85%) 
Rash: hand-foot skin reaction  1  3/63 (4.76%)  4/52 (7.69%) 
Vascular disorders     
Thrombosis/thrombus/embolism  1  0/63 (0.00%)  6/52 (11.54%) 
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: Deirdre Cohen, MD
Organization: Perlmutter Cancer Center at NYU Langone
Phone: 212-731-5656
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00982592     History of Changes
Other Study ID Numbers: NCI-2011-01425
NCI-2011-01425 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
09-0356
CDR0000655339
NYU 09-0356 ( Other Identifier: New York University Langone Medical Center )
8376 ( Other Identifier: CTEP )
N01CM00038 ( U.S. NIH Grant/Contract )
N01CM00071 ( U.S. NIH Grant/Contract )
P30CA016087 ( U.S. NIH Grant/Contract )
N01CM00070 ( U.S. NIH Grant/Contract )
First Submitted: September 22, 2009
First Posted: September 23, 2009
Results First Submitted: December 16, 2015
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016