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Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00238303
Recruitment Status : Completed
First Posted : October 13, 2005
Results First Posted : July 10, 2013
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Interventions Drug: vorinostat
Procedure: conventional surgery
Enrollment 103
Recruitment Details Participants were recruited from 24 medical clinics in the United States between September 2005 to May 2008.
Pre-assignment Details  
Arm/Group Title Stratum 1 (Not Undergoing Surgery) Stratum 2 (Undergoing Surgery) Stratum 3 (Not Undergoing Surgery)
Hide Arm/Group Description

Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

surgery : Patients undergo surgery to remove tumor

Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

Period Title: Overall Study
Started 68 15 20
Completed 53 13 11
Not Completed 15 2 9
Reason Not Completed
Withdrawal by Subject             11             1             2
Death             1             0             1
Other Medical Problems             2             0             2
Poor tolerance of study treatment             1             0             1
Adverse Event             0             1             3
Arm/Group Title Stratum 1 (Not Undergoing Surgery) Stratum 2 (Undergoing Surgery) Stratum 3 (Not Undergoing Surgery) Total
Hide Arm/Group Description

Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

surgery : Patients undergo surgery to remove tumor

Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

Total of all reporting groups
Overall Number of Baseline Participants 68 15 20 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 68 participants 15 participants 20 participants 103 participants
58
(26 to 78)
49
(23 to 61)
55.5
(25 to 78)
56
(23 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 15 participants 20 participants 103 participants
Female
30
  44.1%
4
  26.7%
10
  50.0%
44
  42.7%
Male
38
  55.9%
11
  73.3%
10
  50.0%
59
  57.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 68 participants 15 participants 20 participants 103 participants
68 15 20 103
1.Primary Outcome
Title Proportion of Successes (Patients Alive and Progression-free)
Hide Description

Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 95% confidence interval estimated by the exact method.

Definition of progression:

Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.

Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
68 Stratum 1 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed.
Arm/Group Title Stratum 1 Patients That Started Treatment Stratum 2 (Undergoing Surgery) Stratum 3 (Not Undergoing Surgery)
Hide Arm/Group Description:

Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

surgery : Patients undergo surgery to remove tumor

Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

Overall Number of Participants Analyzed 66 15 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.2
(7.5 to 26.1)
26.7
(7.8 to 55.1)
10
(1.2 to 31.7)
2.Secondary Outcome
Title Survival
Hide Description Estimated using Kaplan-Meier survival curve.
Time Frame From study registration to date of death due to any cause or last follow-up (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was alive at last follow-up.
Arm/Group Title Stratum 1 (Not Undergoing Surgery) Stratum 2 (Undergoing Surgery) Stratum 3 (Not Undergoing Surgery)
Hide Arm/Group Description:

Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

surgery : Patients undergo surgery to remove tumor

Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

Overall Number of Participants Analyzed 66 15 20
Median (Full Range)
Unit of Measure: months
5.7
(0.7 to 28)
10.2
(2.8 to 41.6)
2.2
(0.26 to 42.3)
3.Secondary Outcome
Title Confirmed Tumor Response
Hide Description

A confirmed tumor response will be defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations, which include neuroimaging, lasting during a period of at least 6 weeks. Confidence intervals for the true proportion will be calculated using the exact binomial method.

Bidimensionally measurable disease:≥50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.

Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose.

Time Frame Assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description

Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed.

Stratum 2: Since the patients underwent surgery, response is not applicable and hence 0 patients analyzed.

Arm/Group Title Stratum 1 (Not Undergoing Surgery) Stratum 2 (Undergoing Surgery) Stratum 3 (Not Undergoing Surgery)
Hide Arm/Group Description:

Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

surgery : Patients undergo surgery to remove tumor

Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

Overall Number of Participants Analyzed 66 0 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.0
(0.4 to 10.5)
0
(0 to 16.8)
4.Secondary Outcome
Title Time to Progression
Hide Description

Estimated using Kaplan-Meier survival curve.

Definition of progression:

Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.

Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions.

Time Frame From registration to disease progression (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Stratum 1: 68 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was progression-free at last follow-up.
Arm/Group Title Stratum 1 Patients That Started Treatment Stratum 2 (Undergoing Surgery) Stratum 3 (Not Undergoing Surgery)
Hide Arm/Group Description:

Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

surgery : Patients undergo surgery to remove tumor

Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.

Overall Number of Participants Analyzed 66 15 20
Median (Full Range)
Unit of Measure: months
1.9
(0.3 to 28)
3.7
(1.4 to 41.6)
1.4
(0.20 to 42.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stratum 1 (Not Undergoing Surgery) Stratum 2 (Undergoing Surgery) Stratum 3 (Not Undergoing Surgery)
Hide Arm/Group Description vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest. surgery : Patients undergo surgery to remove tumor vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
All-Cause Mortality
Stratum 1 (Not Undergoing Surgery) Stratum 2 (Undergoing Surgery) Stratum 3 (Not Undergoing Surgery)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Stratum 1 (Not Undergoing Surgery) Stratum 2 (Undergoing Surgery) Stratum 3 (Not Undergoing Surgery)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/66 (19.70%)      3/15 (20.00%)      4/20 (20.00%)    
Cardiac disorders       
Arrhythmia supraventricular  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Diarrhea  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Dysphagia  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Nausea  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Vomiting  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
General disorders       
Disease progression  1  1/66 (1.52%)  1 0/15 (0.00%)  0 1/20 (5.00%)  1
Fatigue  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Infections and infestations       
Bladder infection  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Bronchitis  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Mucosal infection  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Pneumonia  1  3/66 (4.55%)  3 0/15 (0.00%)  0 0/20 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Amylase increased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Leukocyte count decreased  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Lipase increased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Neutrophil count decreased  1  3/66 (4.55%)  3 0/15 (0.00%)  0 0/20 (0.00%)  0
Platelet count decreased  1  7/66 (10.61%)  7 0/15 (0.00%)  0 1/20 (5.00%)  1
Metabolism and nutrition disorders       
Blood glucose increased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Dehydration  1  2/66 (3.03%)  3 0/15 (0.00%)  0 0/20 (0.00%)  0
Serum phosphate decreased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Serum potassium decreased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Serum sodium decreased  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Serum sodium increased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscle weakness left-sided  1  0/66 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Muscle weakness lower limb  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders       
Central nervous system necrosis  1  0/66 (0.00%)  0 1/15 (6.67%)  1 0/20 (0.00%)  0
Cognitive disturbance  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Depressed level of consciousness  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Dizziness  1  1/66 (1.52%)  1 0/15 (0.00%)  0 1/20 (5.00%)  1
Headache  1  0/66 (0.00%)  0 2/15 (13.33%)  2 0/20 (0.00%)  0
Hydrocephalus  1  1/66 (1.52%)  1 1/15 (6.67%)  1 0/20 (0.00%)  0
Intracranial hemorrhage  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Peripheral motor neuropathy  1  2/66 (3.03%)  2 0/15 (0.00%)  0 1/20 (5.00%)  1
Seizure  1  2/66 (3.03%)  2 0/15 (0.00%)  0 1/20 (5.00%)  1
Speech disorder  1  1/66 (1.52%)  1 0/15 (0.00%)  0 1/20 (5.00%)  1
Syncope  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Psychiatric disorders       
Anxiety  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Confusion  1  3/66 (4.55%)  3 0/15 (0.00%)  0 0/20 (0.00%)  0
Renal and urinary disorders       
Renal failure  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Vascular disorders       
Hypertension  1  1/66 (1.52%)  1 0/15 (0.00%)  0 1/20 (5.00%)  1
Hypotension  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Thrombosis  1  3/66 (4.55%)  3 0/15 (0.00%)  0 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stratum 1 (Not Undergoing Surgery) Stratum 2 (Undergoing Surgery) Stratum 3 (Not Undergoing Surgery)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   65/66 (98.48%)      14/15 (93.33%)      19/20 (95.00%)    
Blood and lymphatic system disorders       
Hemoglobin decreased  1  34/66 (51.52%)  156 10/15 (66.67%)  47 9/20 (45.00%)  57
Eye disorders       
Diplopia  1  0/66 (0.00%)  0 1/15 (6.67%)  1 0/20 (0.00%)  0
Vision blurred  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Vitreous hemorrhage  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  12/66 (18.18%)  41 3/15 (20.00%)  4 1/20 (5.00%)  1
Constipation  1  4/66 (6.06%)  10 1/15 (6.67%)  11 2/20 (10.00%)  5
Diarrhea  1  21/66 (31.82%)  63 7/15 (46.67%)  27 8/20 (40.00%)  12
Dry mouth  1  2/66 (3.03%)  6 0/15 (0.00%)  0 0/20 (0.00%)  0
Dyspepsia  1  2/66 (3.03%)  3 0/15 (0.00%)  0 1/20 (5.00%)  1
Dysphagia  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Esophageal mucositis  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Esophagitis  1  0/66 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Flatulence  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Hemorrhoids  1  0/66 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Mucositis oral  1  3/66 (4.55%)  4 0/15 (0.00%)  0 0/20 (0.00%)  0
Nausea  1  17/66 (25.76%)  52 8/15 (53.33%)  13 7/20 (35.00%)  15
Oral hemorrhage  1  0/66 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Vomiting  1  8/66 (12.12%)  14 4/15 (26.67%)  5 3/20 (15.00%)  4
General disorders       
Chills  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Edema limbs  1  3/66 (4.55%)  4 1/15 (6.67%)  2 0/20 (0.00%)  0
Fatigue  1  57/66 (86.36%)  192 11/15 (73.33%)  72 16/20 (80.00%)  46
Fever  1  2/66 (3.03%)  3 1/15 (6.67%)  3 0/20 (0.00%)  0
Gait abnormal  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Localized edema  1  2/66 (3.03%)  3 0/15 (0.00%)  0 0/20 (0.00%)  0
Infections and infestations       
Abdominal infection  1  0/66 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Bladder infection  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Gingival infection  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Infection  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Penile infection  1  0/66 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Pneumonia  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Sepsis  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Sinusitis  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Upper respiratory infection  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Vaginal infection  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Injury, poisoning and procedural complications       
Arterial injury - Extremity-lower  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Vascular access complication  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  4/66 (6.06%)  11 2/15 (13.33%)  3 3/20 (15.00%)  8
Alkaline phosphatase increased  1  7/66 (10.61%)  42 1/15 (6.67%)  1 2/20 (10.00%)  6
Aspartate aminotransferase increased  1  11/66 (16.67%)  19 2/15 (13.33%)  2 3/20 (15.00%)  8
Blood bilirubin increased  1  1/66 (1.52%)  1 3/15 (20.00%)  3 1/20 (5.00%)  1
CD4 lymphocytes decreased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Creatine phosphokinase increased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Creatinine increased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 1/20 (5.00%)  8
Laboratory test abnormal  1  1/66 (1.52%)  4 0/15 (0.00%)  0 1/20 (5.00%)  1
Leukocyte count decreased  1  26/66 (39.39%)  109 9/15 (60.00%)  32 5/20 (25.00%)  31
Lymphocyte count decreased  1  5/66 (7.58%)  21 0/15 (0.00%)  0 2/20 (10.00%)  2
Neutrophil count decreased  1  20/66 (30.30%)  87 6/15 (40.00%)  19 5/20 (25.00%)  16
Platelet count decreased  1  45/66 (68.18%)  198 12/15 (80.00%)  33 17/20 (85.00%)  55
Serum cholesterol increased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 1/20 (5.00%)  1
Weight gain  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Weight loss  1  2/66 (3.03%)  2 1/15 (6.67%)  1 3/20 (15.00%)  9
Metabolism and nutrition disorders       
Acidosis  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Alkalosis  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Anorexia  1  18/66 (27.27%)  43 5/15 (33.33%)  22 10/20 (50.00%)  18
Blood bicarbonate decreased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Blood glucose increased  1  22/66 (33.33%)  37 1/15 (6.67%)  1 3/20 (15.00%)  37
Dehydration  1  6/66 (9.09%)  10 2/15 (13.33%)  2 1/20 (5.00%)  1
Serum albumin decreased  1  4/66 (6.06%)  6 0/15 (0.00%)  0 1/20 (5.00%)  1
Serum calcium decreased  1  4/66 (6.06%)  7 1/15 (6.67%)  1 1/20 (5.00%)  2
Serum calcium increased  1  0/66 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Serum glucose decreased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Serum magnesium increased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Serum phosphate decreased  1  1/66 (1.52%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Serum potassium decreased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Serum potassium increased  1  1/66 (1.52%)  1 0/15 (0.00%)  0 1/20 (5.00%)  2
Serum sodium decreased  1  3/66 (4.55%)  3 0/15 (0.00%)  0 2/20 (10.00%)  7
Serum sodium increased  1  2/66 (3.03%)  3 0/15 (0.00%)  0 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/66 (1.52%)  1 0/15 (0.00%)  0 1/20 (5.00%)  1
Back pain  1  1/66 (1.52%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Muscle weakness  1  7/66 (10.61%)  7 0/15 (0.00%)  0 3/20 (15.00%)  4
Muscle weakness left-sided  1  1/66 (1.52%)  1 0/15 (0.00%)  0 1/20 (5.00%)  1
Muscle weakness lower limb  1  3/66 (4.55%)  3 0/15 (0.00%)  0 1/20 (5.00%)  2
Muscle weakness right-sided  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Myalgia  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Pain in extremity  1  2/66 (3.03%)  2 0/15 (0.00%)  0 1/20 (5.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Treatment related secondary malignancy  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders       
Accessory nerve disorder  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Ataxia  1  7/66 (10.61%)  9 0/15 (0.00%)  0 1/20 (5.00%)  2
Cognitive disturbance  1  1/66 (1.52%)  1 0/15 (0.00%)  0 1/20 (5.00%)  4
Depressed level of consciousness  1  3/66 (4.55%)  3 0/15 (0.00%)  0 2/20 (10.00%)  2
Dizziness  1  5/66 (7.58%)  5 1/15 (6.67%)  1 0/20 (0.00%)  0
Dysgeusia  1  15/66 (22.73%)  51 3/15 (20.00%)  14 4/20 (20.00%)  6
Extrapyramidal disorder  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Headache  1  12/66 (18.18%)  21 3/15 (20.00%)  3 2/20 (10.00%)  3
Ischemia cerebrovascular  1  0/66 (0.00%)  0 1/15 (6.67%)  1 0/20 (0.00%)  0
Memory impairment  1  2/66 (3.03%)  2 0/15 (0.00%)  0 1/20 (5.00%)  4
Neurological disorder NOS  1  1/66 (1.52%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Peripheral motor neuropathy  1  1/66 (1.52%)  2 0/15 (0.00%)  0 1/20 (5.00%)  34
Peripheral sensory neuropathy  1  1/66 (1.52%)  1 0/15 (0.00%)  0 1/20 (5.00%)  11
Seizure  1  2/66 (3.03%)  2 0/15 (0.00%)  0 2/20 (10.00%)  2
Sinus pain  1  0/66 (0.00%)  0 1/15 (6.67%)  6 0/20 (0.00%)  0
Speech disorder  1  7/66 (10.61%)  7 0/15 (0.00%)  0 1/20 (5.00%)  19
Syncope  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Psychiatric disorders       
Anxiety  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Confusion  1  3/66 (4.55%)  4 0/15 (0.00%)  0 1/20 (5.00%)  1
Depression  1  2/66 (3.03%)  4 0/15 (0.00%)  0 0/20 (0.00%)  0
Insomnia  1  1/66 (1.52%)  4 1/15 (6.67%)  9 1/20 (5.00%)  1
Libido decreased  1  0/66 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders       
Hemorrhage urinary tract  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Urinary frequency  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Urogenital disorder  1  2/66 (3.03%)  3 0/15 (0.00%)  0 1/20 (5.00%)  2
Respiratory, thoracic and mediastinal disorders       
Aspiration  1  0/66 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Cough  1  1/66 (1.52%)  1 1/15 (6.67%)  2 2/20 (10.00%)  4
Dyspnea  1  3/66 (4.55%)  3 0/15 (0.00%)  0 1/20 (5.00%)  1
Hiccups  1  2/66 (3.03%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Hypoxia  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Laryngeal mucositis  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Pharyngolaryngeal pain  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Pneumonitis  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Pulmonary hypertension  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia  1  2/66 (3.03%)  7 0/15 (0.00%)  0 1/20 (5.00%)  1
Dry skin  1  2/66 (3.03%)  21 1/15 (6.67%)  7 0/20 (0.00%)  0
Erythema multiforme  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Petechiae  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Pruritus  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Rash desquamating  1  2/66 (3.03%)  3 0/15 (0.00%)  0 0/20 (0.00%)  0
Vascular disorders       
Hemorrhage  1  0/66 (0.00%)  0 1/15 (6.67%)  1 0/20 (0.00%)  0
Hypertension  1  1/66 (1.52%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Hypotension  1  2/66 (3.03%)  2 0/15 (0.00%)  0 1/20 (5.00%)  1
Thrombosis  1  3/66 (4.55%)  3 0/15 (0.00%)  0 1/20 (5.00%)  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
Layout table for Results Point of Contact information
Name/Title: Evanthia Galanis, M.D.
Organization: Mayo Clinic
Phone: (507) 284-3902
EMail: galanis.evanthia@mayo.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00238303    
Obsolete Identifiers: NCT01647100
Other Study ID Numbers: NCI-2009-00646
NCI-2009-00646 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000445405
NCCTG-N047B
N047B ( Other Identifier: North Central Cancer Treatment Group )
N047B ( Other Identifier: CTEP )
U10CA025224 ( U.S. NIH Grant/Contract )
First Submitted: October 12, 2005
First Posted: October 13, 2005
Results First Submitted: December 11, 2012
Results First Posted: July 10, 2013
Last Update Posted: May 23, 2014