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Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00972478
Recruitment Status : Active, not recruiting
First Posted : September 7, 2009
Results First Posted : October 31, 2016
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ann Arbor Stage II Non-Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Interventions Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Prednisone
Biological: Rituximab
Drug: Vincristine Sulfate
Drug: Vorinostat
Enrollment 83
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ph I: R-CHOP+Vorinostat (400mg D1-9) Ph II: R-CHOP+Vorinostat
Hide Arm/Group Description Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 11 72
Eligible and Began Protocol Therapy 9 63
Completed 4 34
Not Completed 7 38
Reason Not Completed
Adverse Event             3             16
Withdrawal by Subject             1             8
Progression/Relapse             0             2
Death             0             2
Not protocol specified             1             1
Ineligible             1             7
Not start protocol treatment             1             2
Arm/Group Title Ph I: R-CHOP+Vorinostat (400mg D1-9) Ph II: R-CHOP+Vorinostat Total
Hide Arm/Group Description Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 9 63 72
Hide Baseline Analysis Population Description
Eligible patients who began protocol therapy
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants 63 participants 72 participants
66.9
(46.4 to 83.8)
64.1
(19.6 to 80.8)
64.2
(19.6 to 83.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 63 participants 72 participants
Female
3
  33.3%
27
  42.9%
30
  41.7%
Male
6
  66.7%
36
  57.1%
42
  58.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 63 participants 72 participants
White 9 54 63
Black 0 3 3
Asian 0 5 5
Unknown 0 1 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 63 participants 72 participants
Hispanic 3 4 7
Non-Hispanic 6 59 65
1.Primary Outcome
Title Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)
Hide Description Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I eligible patients receiving any amount of the assigned dose during Cycle 1 (1 Cycle = 21 days) or whom developed a dose-limiting toxicity (DLT).
Arm/Group Title Ph I: R-CHOP+Vorinostat (400mg D1-9)
Hide Arm/Group Description:
Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: mg PO Once daily Days 1-9
400
2.Primary Outcome
Title Progression-free Survival (Phase II)
Hide Description From date of registration to date of first documentation of progressive disease, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received the protocol treatment in the Phase II portion of the study.
Arm/Group Title Ph II: R-CHOP+Vorinostat
Hide Arm/Group Description:
Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73
(59.6 to 81.9)
3.Secondary Outcome
Title Overall Survival (Phase II)
Hide Description From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received the protocol treatment in the Phase II portion of the study.
Arm/Group Title Ph II: R-CHOP+Vorinostat
Hide Arm/Group Description:
Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86
(74.3 to 92.3)
4.Secondary Outcome
Title Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)
Hide Description Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Time Frame Up to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received the protocol treatment in the Phase II portion of the study
Arm/Group Title Ph II: R-CHOP+Vorinostat
Hide Arm/Group Description:
Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81
(69.1 to 89.8)
5.Secondary Outcome
Title Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL
Hide Description Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time Frame Up to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
Arm/Group Title Ph I: R-CHOP+Vorinostat (400mg D1-9) Ph II: R-CHOP+Vorinostat
Hide Arm/Group Description:
Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 9 63
Measure Type: Number
Unit of Measure: Participants
Abdominal pain 1 3
Acute kidney injury 0 1
Alanine aminotransferase increased 0 1
Anemia 4 22
Anorexia 1 2
Aspartate aminotransferase increased 0 1
Atrial fibrillation 0 1
Bladder spasm 0 1
Bronchial infection 0 1
CD4 lymphocytes decreased 0 1
CPK increased 0 1
Carbon monoxide diffusing capacity decreased 0 1
Colitis 1 0
Creatinine increased 1 0
Cystitis noninfective 0 1
Dehydration 2 4
Depression 1 0
Diarrhea 2 2
Disseminated intravascular coagulation 1 0
Dizziness 1 0
Duodenal perforation 0 1
Dysphagia 0 1
Dyspnea 0 1
Electrocardiogram QT corrected interval prolonged 1 1
Fatigue 3 9
Febrile neutropenia 3 24
Fecal incontinence 0 1
Gastrointestinal disorders - Other, specify 0 1
Generalized muscle weakness 2 2
Hematuria 1 0
Hiccups 0 1
Hyperglycemia 0 4
Hypoalbuminemia 1 3
Hypocalcemia 1 0
Hypokalemia 2 8
Hyponatremia 0 6
Hypophosphatemia 1 2
Hypotension 0 3
Infections and infestations - Other, specify 1 3
Jejunal perforation 0 1
Left ventricular systolic dysfunction 0 1
Leukocytosis 0 1
Lung infection 0 4
Lymphocyte count decreased 4 20
Mucosal infection 0 1
Mucositis oral 1 3
Multi-organ failure 1 0
Myalgia 1 2
Myocardial infarction 0 2
Nausea 1 3
Neutrophil count decreased 8 37
Obstruction gastric 0 1
Pain 0 1
Paronychia 0 1
Peripheral motor neuropathy 1 0
Platelet count decreased 4 22
Pneumonitis 0 1
Recurrent laryngeal nerve palsy 0 1
Respiratory failure 0 1
Sepsis 3 11
Sinus tachycardia 0 1
Sinusitis 0 1
Small intestinal obstruction 0 1
Stoma site infection 0 1
Syncope 0 4
Urinary tract infection 0 3
Urinary tract pain 0 2
Urine output decreased 1 0
Vasovagal reaction 0 1
Visceral arterial ischemia 1 0
Vomiting 0 2
Weight loss 0 3
White blood cell decreased 7 32
Time Frame Up to week 26
Adverse Event Reporting Description Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
 
Arm/Group Title Ph I: R-CHOP+Vorinostat (400mg D1-9) Ph II: R-CHOP+Vorinostat
Hide Arm/Group Description Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Ph I: R-CHOP+Vorinostat (400mg D1-9) Ph II: R-CHOP+Vorinostat
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ph I: R-CHOP+Vorinostat (400mg D1-9) Ph II: R-CHOP+Vorinostat
Affected / at Risk (%) Affected / at Risk (%)
Total   5/9 (55.56%)   44/63 (69.84%) 
Blood and lymphatic system disorders     
Anemia   3/9 (33.33%)  13/63 (20.63%) 
Disseminated intravascular coagulation   1/9 (11.11%)  0/63 (0.00%) 
Febrile neutropenia   3/9 (33.33%)  22/63 (34.92%) 
Cardiac disorders     
Atrial fibrillation   0/9 (0.00%)  1/63 (1.59%) 
Cardiac arrest   0/9 (0.00%)  1/63 (1.59%) 
Left ventricular systolic dysfunction   0/9 (0.00%)  1/63 (1.59%) 
Myocardial infarction   0/9 (0.00%)  3/63 (4.76%) 
Gastrointestinal disorders     
Abdominal pain   1/9 (11.11%)  1/63 (1.59%) 
Colitis   1/9 (11.11%)  0/63 (0.00%) 
Constipation   0/9 (0.00%)  1/63 (1.59%) 
Diarrhea   0/9 (0.00%)  1/63 (1.59%) 
Dysphagia   0/9 (0.00%)  1/63 (1.59%) 
Gastroesophageal reflux disease   0/9 (0.00%)  1/63 (1.59%) 
Gastrointestinal disorders-Other   0/9 (0.00%)  2/63 (3.17%) 
Jejunal perforation   0/9 (0.00%)  1/63 (1.59%) 
Mucositis oral   1/9 (11.11%)  0/63 (0.00%) 
Nausea   0/9 (0.00%)  2/63 (3.17%) 
Small intestinal obstruction   0/9 (0.00%)  1/63 (1.59%) 
Vomiting   0/9 (0.00%)  2/63 (3.17%) 
General disorders     
Death NOS   0/9 (0.00%)  1/63 (1.59%) 
Fatigue   1/9 (11.11%)  3/63 (4.76%) 
Fever   0/9 (0.00%)  2/63 (3.17%) 
Malaise   0/9 (0.00%)  1/63 (1.59%) 
Multi-organ failure   1/9 (11.11%)  0/63 (0.00%) 
Non-cardiac chest pain   0/9 (0.00%)  1/63 (1.59%) 
Pain   0/9 (0.00%)  2/63 (3.17%) 
Infections and infestations     
Bronchial infection   0/9 (0.00%)  1/63 (1.59%) 
Infections and infestations-Other   0/9 (0.00%)  2/63 (3.17%) 
Lung infection   1/9 (11.11%)  4/63 (6.35%) 
Paronychia   0/9 (0.00%)  1/63 (1.59%) 
Sepsis   3/9 (33.33%)  8/63 (12.70%) 
Sinusitis   0/9 (0.00%)  1/63 (1.59%) 
Stoma site infection   0/9 (0.00%)  1/63 (1.59%) 
Urinary tract infection   0/9 (0.00%)  2/63 (3.17%) 
Investigations     
Aspartate aminotransferase increased   0/9 (0.00%)  1/63 (1.59%) 
Creatinine increased   1/9 (11.11%)  2/63 (3.17%) 
Electrocardiogram QT corrected interval prolonged   1/9 (11.11%)  1/63 (1.59%) 
Lymphocyte count decreased   1/9 (11.11%)  4/63 (6.35%) 
Neutrophil count decreased   3/9 (33.33%)  16/63 (25.40%) 
Platelet count decreased   4/9 (44.44%)  16/63 (25.40%) 
Weight loss   0/9 (0.00%)  1/63 (1.59%) 
White blood cell decreased   2/9 (22.22%)  10/63 (15.87%) 
Metabolism and nutrition disorders     
Anorexia   0/9 (0.00%)  2/63 (3.17%) 
Dehydration   1/9 (11.11%)  4/63 (6.35%) 
Hypercalcemia   0/9 (0.00%)  1/63 (1.59%) 
Hypoalbuminemia   0/9 (0.00%)  1/63 (1.59%) 
Hypocalcemia   1/9 (11.11%)  0/63 (0.00%) 
Hypokalemia   2/9 (22.22%)  3/63 (4.76%) 
Hypophosphatemia   1/9 (11.11%)  0/63 (0.00%) 
Musculoskeletal and connective tissue disorders     
Generalized muscle weakness   0/9 (0.00%)  1/63 (1.59%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified - Other   0/9 (0.00%)  1/63 (1.59%) 
Nervous system disorders     
Cognitive disturbance   0/9 (0.00%)  1/63 (1.59%) 
Dizziness   0/9 (0.00%)  1/63 (1.59%) 
Recurrent laryngeal nerve palsy   0/9 (0.00%)  1/63 (1.59%) 
Reversible posterior leukoencephalopathy syndrome   0/9 (0.00%)  1/63 (1.59%) 
Syncope   0/9 (0.00%)  3/63 (4.76%) 
Psychiatric disorders     
Confusion   0/9 (0.00%)  2/63 (3.17%) 
Renal and urinary disorders     
Acute kidney injury   0/9 (0.00%)  1/63 (1.59%) 
Cystitis noninfective   0/9 (0.00%)  1/63 (1.59%) 
Urinary frequency   0/9 (0.00%)  1/63 (1.59%) 
Urinary tract pain   0/9 (0.00%)  1/63 (1.59%) 
Respiratory, thoracic and mediastinal disorders     
Cough   0/9 (0.00%)  1/63 (1.59%) 
Dyspnea   0/9 (0.00%)  1/63 (1.59%) 
Hiccups   0/9 (0.00%)  1/63 (1.59%) 
Pneumonitis   0/9 (0.00%)  2/63 (3.17%) 
Pulmonary edema   0/9 (0.00%)  1/63 (1.59%) 
Respiratory failure   0/9 (0.00%)  1/63 (1.59%) 
Vascular disorders     
Hypotension   0/9 (0.00%)  3/63 (4.76%) 
Thromboembolic event   0/9 (0.00%)  2/63 (3.17%) 
Visceral arterial ischemia   1/9 (11.11%)  0/63 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ph I: R-CHOP+Vorinostat (400mg D1-9) Ph II: R-CHOP+Vorinostat
Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   63/63 (100.00%) 
Blood and lymphatic system disorders     
Anemia   9/9 (100.00%)  52/63 (82.54%) 
Cardiac disorders     
Sinus tachycardia   0/9 (0.00%)  9/63 (14.29%) 
Eye disorders     
Blurred vision   2/9 (22.22%)  8/63 (12.70%) 
Dry eye   2/9 (22.22%)  0/63 (0.00%) 
Eye disorders-Other   1/9 (11.11%)  0/63 (0.00%) 
Photophobia   1/9 (11.11%)  0/63 (0.00%) 
Watering eyes   1/9 (11.11%)  0/63 (0.00%) 
Gastrointestinal disorders     
Abdominal pain   2/9 (22.22%)  16/63 (25.40%) 
Bloating   1/9 (11.11%)  3/63 (4.76%) 
Constipation   5/9 (55.56%)  26/63 (41.27%) 
Diarrhea   7/9 (77.78%)  31/63 (49.21%) 
Dry mouth   3/9 (33.33%)  6/63 (9.52%) 
Dyspepsia   0/9 (0.00%)  4/63 (6.35%) 
Fecal incontinence   1/9 (11.11%)  1/63 (1.59%) 
Gastrointestinal disorders-Other   2/9 (22.22%)  2/63 (3.17%) 
Hemorrhoids   0/9 (0.00%)  4/63 (6.35%) 
Mucositis oral   1/9 (11.11%)  22/63 (34.92%) 
Nausea   8/9 (88.89%)  43/63 (68.25%) 
Oral pain   1/9 (11.11%)  2/63 (3.17%) 
Rectal mucositis   1/9 (11.11%)  0/63 (0.00%) 
Vomiting   4/9 (44.44%)  22/63 (34.92%) 
General disorders     
Chills   2/9 (22.22%)  10/63 (15.87%) 
Edema face   3/9 (33.33%)  0/63 (0.00%) 
Edema limbs   2/9 (22.22%)  17/63 (26.98%) 
Fatigue   8/9 (88.89%)  45/63 (71.43%) 
Fever   1/9 (11.11%)  18/63 (28.57%) 
Gait disturbance   2/9 (22.22%)  3/63 (4.76%) 
Infusion related reaction   0/9 (0.00%)  4/63 (6.35%) 
Non-cardiac chest pain   0/9 (0.00%)  4/63 (6.35%) 
Pain   4/9 (44.44%)  7/63 (11.11%) 
Infections and infestations     
Infections and infestations-Other   1/9 (11.11%)  4/63 (6.35%) 
Mucosal infection   1/9 (11.11%)  3/63 (4.76%) 
Peripheral nerve infection   1/9 (11.11%)  0/63 (0.00%) 
Rhinitis infective   1/9 (11.11%)  2/63 (3.17%) 
Skin infection   1/9 (11.11%)  5/63 (7.94%) 
Urinary tract infection   1/9 (11.11%)  5/63 (7.94%) 
Wound infection   1/9 (11.11%)  0/63 (0.00%) 
Injury, poisoning and procedural complications     
Bruising   2/9 (22.22%)  3/63 (4.76%) 
Fall   1/9 (11.11%)  2/63 (3.17%) 
Fracture   1/9 (11.11%)  0/63 (0.00%) 
Investigations     
Activated partial thromboplastin time prolonged   1/9 (11.11%)  0/63 (0.00%) 
Alanine aminotransferase increased   2/9 (22.22%)  16/63 (25.40%) 
Alkaline phosphatase increased   0/9 (0.00%)  11/63 (17.46%) 
Aspartate aminotransferase increased   2/9 (22.22%)  13/63 (20.63%) 
Blood bilirubin increased   1/9 (11.11%)  4/63 (6.35%) 
CD4 lymphocytes decreased   0/9 (0.00%)  4/63 (6.35%) 
Cardiac troponin I increased   1/9 (11.11%)  1/63 (1.59%) 
Creatinine increased   1/9 (11.11%)  6/63 (9.52%) 
Electrocardiogram QT corrected interval prolonged   0/9 (0.00%)  5/63 (7.94%) 
Investigations-Other   2/9 (22.22%)  0/63 (0.00%) 
Lymphocyte count decreased   7/9 (77.78%)  26/63 (41.27%) 
Neutrophil count decreased   7/9 (77.78%)  35/63 (55.56%) 
Platelet count decreased   8/9 (88.89%)  32/63 (50.79%) 
Urine output decreased   1/9 (11.11%)  0/63 (0.00%) 
Weight gain   2/9 (22.22%)  4/63 (6.35%) 
Weight loss   2/9 (22.22%)  13/63 (20.63%) 
White blood cell decreased   8/9 (88.89%)  40/63 (63.49%) 
Metabolism and nutrition disorders     
Anorexia   6/9 (66.67%)  23/63 (36.51%) 
Dehydration   2/9 (22.22%)  7/63 (11.11%) 
Hyperglycemia   2/9 (22.22%)  12/63 (19.05%) 
Hyperkalemia   2/9 (22.22%)  0/63 (0.00%) 
Hypoalbuminemia   4/9 (44.44%)  20/63 (31.75%) 
Hypocalcemia   3/9 (33.33%)  20/63 (31.75%) 
Hypoglycemia   1/9 (11.11%)  4/63 (6.35%) 
Hypokalemia   4/9 (44.44%)  17/63 (26.98%) 
Hypomagnesemia   1/9 (11.11%)  8/63 (12.70%) 
Hyponatremia   4/9 (44.44%)  23/63 (36.51%) 
Hypophosphatemia   1/9 (11.11%)  7/63 (11.11%) 
Metabolism and nutrition disorders - Other, specify   2/9 (22.22%)  1/63 (1.59%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   0/9 (0.00%)  8/63 (12.70%) 
Back pain   1/9 (11.11%)  10/63 (15.87%) 
Bone pain   4/9 (44.44%)  9/63 (14.29%) 
Chest wall pain   2/9 (22.22%)  5/63 (7.94%) 
Flank pain   1/9 (11.11%)  0/63 (0.00%) 
Generalized muscle weakness   5/9 (55.56%)  12/63 (19.05%) 
Muscle weakness upper limb   1/9 (11.11%)  0/63 (0.00%) 
Myalgia   1/9 (11.11%)  9/63 (14.29%) 
Neck pain   0/9 (0.00%)  4/63 (6.35%) 
Pain in extremity   2/9 (22.22%)  4/63 (6.35%) 
Nervous system disorders     
Dizziness   4/9 (44.44%)  20/63 (31.75%) 
Dysgeusia   3/9 (33.33%)  8/63 (12.70%) 
Headache   4/9 (44.44%)  20/63 (31.75%) 
Lethargy   1/9 (11.11%)  1/63 (1.59%) 
Memory impairment   1/9 (11.11%)  0/63 (0.00%) 
Movements involuntary   1/9 (11.11%)  0/63 (0.00%) 
Paresthesia   3/9 (33.33%)  1/63 (1.59%) 
Peripheral motor neuropathy   5/9 (55.56%)  4/63 (6.35%) 
Peripheral sensory neuropathy   4/9 (44.44%)  19/63 (30.16%) 
Tremor   1/9 (11.11%)  0/63 (0.00%) 
Psychiatric disorders     
Agitation   1/9 (11.11%)  0/63 (0.00%) 
Anxiety   1/9 (11.11%)  9/63 (14.29%) 
Confusion   1/9 (11.11%)  1/63 (1.59%) 
Depression   3/9 (33.33%)  6/63 (9.52%) 
Insomnia   6/9 (66.67%)  10/63 (15.87%) 
Renal and urinary disorders     
Hematuria   1/9 (11.11%)  4/63 (6.35%) 
Proteinuria   0/9 (0.00%)  7/63 (11.11%) 
Renal and urinary disorders-Other   1/9 (11.11%)  1/63 (1.59%) 
Urinary frequency   6/9 (66.67%)  5/63 (7.94%) 
Urinary incontinence   1/9 (11.11%)  2/63 (3.17%) 
Urinary retention   1/9 (11.11%)  0/63 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis   1/9 (11.11%)  3/63 (4.76%) 
Cough   5/9 (55.56%)  15/63 (23.81%) 
Dyspnea   2/9 (22.22%)  16/63 (25.40%) 
Hiccups   2/9 (22.22%)  3/63 (4.76%) 
Hypoxia   2/9 (22.22%)  0/63 (0.00%) 
Postnasal drip   2/9 (22.22%)  1/63 (1.59%) 
Resp, thoracic and mediastinal disorders - Other   1/9 (11.11%)  0/63 (0.00%) 
Sore throat   1/9 (11.11%)  5/63 (7.94%) 
Skin and subcutaneous tissue disorders     
Alopecia   7/9 (77.78%)  21/63 (33.33%) 
Dry skin   1/9 (11.11%)  3/63 (4.76%) 
Erythema multiforme   2/9 (22.22%)  0/63 (0.00%) 
Hyperhidrosis   2/9 (22.22%)  2/63 (3.17%) 
Nail discoloration   2/9 (22.22%)  3/63 (4.76%) 
Pruritus   1/9 (11.11%)  3/63 (4.76%) 
Rash maculo-papular   4/9 (44.44%)  4/63 (6.35%) 
Skin and subcutaneous tissue disorders - Other   2/9 (22.22%)  4/63 (6.35%) 
Skin hyperpigmentation   1/9 (11.11%)  0/63 (0.00%) 
Vascular disorders     
Hematoma   1/9 (11.11%)  0/63 (0.00%) 
Hot flashes   1/9 (11.11%)  5/63 (7.94%) 
Hypertension   4/9 (44.44%)  11/63 (17.46%) 
Hypotension   2/9 (22.22%)  8/63 (12.70%) 
Thromboembolic event   1/9 (11.11%)  4/63 (6.35%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: SWOG
Phone: 206-667-4623
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00972478     History of Changes
Other Study ID Numbers: NCI-2011-01964
NCI-2011-01964 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000653803
S0806 ( Other Identifier: SWOG )
S0806 ( Other Identifier: CTEP )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: September 4, 2009
First Posted: September 7, 2009
Results First Submitted: September 8, 2016
Results First Posted: October 31, 2016
Last Update Posted: October 11, 2019