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Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma

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: NCT00098774
Recruitment Status : Completed
First Posted : December 9, 2004
Results First Posted : September 12, 2014
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Biological: filgrastim
Biological: rituximab
Drug: cytarabine
Drug: etoposide
Drug: leucovorin calcium
Drug: methotrexate
Drug: temozolomide
Enrollment 47
Recruitment Details Between October 2004 and November 2009, 47 participants were recruited at 12 CALGB sites.
Pre-assignment Details Three participants were excluded from analysis because of failure to meet eligibility criteria or to receive protocol therapy.
Arm/Group Title Intensive Combination Chemo & Immunotherapy
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Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11

Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16

Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11

Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)

Period Title: Overall Study
Started 44
Completed 26
Not Completed 18
Reason Not Completed
Adverse Event             2
Disease Progression             9
Withdrawal by Subject             1
Failed (to respond) during induction             4
Physician Decision             2
Arm/Group Title Intensive Combination Chemo & Immunotherapy
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Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11

Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16

Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11

Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)

Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
61
(12 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
23
  52.3%
Male
21
  47.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   4.5%
Native Hawaiian or Other Pacific Islander
2
   4.5%
Black or African American
0
   0.0%
White
40
  90.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants
44
1.Primary Outcome
Title Complete Response Rate After Remission Induction
Hide Description Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.
Time Frame 4 months
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[Not Specified]
Arm/Group Title Intensive Combination Chemo & Immunotherapy
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Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11

Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16

Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11

Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66
(50 to 80)
2.Secondary Outcome
Title 4 Year Progression Free Rate
Hide Description

Percentage of patients who were progression free at 4 years. The 4-year progression free rate was estimated using the Kaplan Meier method.

Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a 25% increase of previous area of gadolinium enhancement, appearance of new areas of T1 gadolinium enhancement or new appearance of malignant cells in the spinal fluid or new tumor appearance in other sites of the body

Time Frame 4 years
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Combination Chemo & Immunotherapy
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Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11

Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16

Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11

Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48
(33 to 63)
3.Secondary Outcome
Title Change From Baseline in Mini-Mental Status Evaluation at 4 Months
Hide Description Neurologic functioning will be assessed using the Mini-Mental Status Evaluation (MMSE), a standardized, bedside tool for evaluation of higher mental function. This assessment is based on a 30-point scale (0-30) with higher scores associated with better performance.
Time Frame Baseline & month 4
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Only 14 participants had both baseline and 4 month MMSE evaluations reported.
Arm/Group Title Intensive Combination Chemo & Immunotherapy
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Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11

Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16

Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11

Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)

Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: units on a scale
Baseline Score
27
(7 to 30)
4 month Score
28
(22 to 30)
Change from Baseline
1
(-1 to 18)
4.Secondary Outcome
Title 4 Year Overall Survival Rate
Hide Description Percentage of patients who were alive at 4 years. The 4-year survival rate was estimated using the Kaplan Meier method.
Time Frame 4 years
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Combination Chemo & Immunotherapy
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Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11

Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16

Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11

Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
65
(49 to 77)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intensive Combination Chemo & Immunotherapy
Hide Arm/Group Description

Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11

Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16

Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11

Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)

All-Cause Mortality
Intensive Combination Chemo & Immunotherapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intensive Combination Chemo & Immunotherapy
Affected / at Risk (%) # Events
Total   15/44 (34.09%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/44 (2.27%)  1
Hemoglobin decreased  1  11/44 (25.00%)  13
Cardiac disorders   
Atrial fibrillation  1  2/44 (4.55%)  2
Cardiopulmonary arrest  1  1/44 (2.27%)  1
Conduction disorder  1  1/44 (2.27%)  1
Sinus bradycardia  1  3/44 (6.82%)  3
Supraventricular tachycardia  1  1/44 (2.27%)  1
Ear and labyrinth disorders   
Hearing impaired  1  1/44 (2.27%)  1
Eye disorders   
Diplopia  1  1/44 (2.27%)  1
Keratitis  1  1/44 (2.27%)  1
Vision blurred  1  1/44 (2.27%)  1
Gastrointestinal disorders   
Abdominal pain  1  2/44 (4.55%)  2
Constipation  1  3/44 (6.82%)  3
Diarrhea  1  6/44 (13.64%)  6
Ear, nose and throat examination abnormal  1  1/44 (2.27%)  1
Flatulence  1  1/44 (2.27%)  1
Mucositis oral  1  6/44 (13.64%)  6
Nausea  1  7/44 (15.91%)  7
Rectal mucositis  1  2/44 (4.55%)  2
Small intestinal mucositis  1  1/44 (2.27%)  1
Upper gastrointestinal hemorrhage  1  1/44 (2.27%)  1
Vomiting  1  5/44 (11.36%)  5
General disorders   
Chills  1  1/44 (2.27%)  1
Disease progression  1  1/44 (2.27%)  1
Edema limbs  1  1/44 (2.27%)  1
Facial pain  1  1/44 (2.27%)  1
Fatigue  1  7/44 (15.91%)  7
Fever  1  1/44 (2.27%)  1
Localized edema  1  1/44 (2.27%)  1
Hepatobiliary disorders   
Cholecystitis  1  1/44 (2.27%)  1
Infections and infestations   
Abdominal infection  1  1/44 (2.27%)  1
Anorectal infection  1  1/44 (2.27%)  1
Catheter related infection  1  1/44 (2.27%)  1
Infection  1  1/44 (2.27%)  1
Lymph gland infection  1  1/44 (2.27%)  1
Opportunistic infection  1  1/44 (2.27%)  1
Peritoneal infection  1  1/44 (2.27%)  1
Rhinitis infective  1  1/44 (2.27%)  1
Sepsis  1  1/44 (2.27%)  1
Urinary tract infection  1  1/44 (2.27%)  2
Investigations   
Activated partial thromboplastin time prolonged  1  1/44 (2.27%)  1
Alanine aminotransferase increased  1  8/44 (18.18%)  10
Alkaline phosphatase increased  1  1/44 (2.27%)  3
Aspartate aminotransferase increased  1  7/44 (15.91%)  8
Blood bilirubin increased  1  6/44 (13.64%)  6
Creatinine increased  1  4/44 (9.09%)  4
Gamma-glutamyltransferase increased  1  1/44 (2.27%)  1
INR increased  1  1/44 (2.27%)  1
Laboratory test abnormal  1  3/44 (6.82%)  3
Leukocyte count decreased  1  6/44 (13.64%)  6
Lymphocyte count decreased  1  2/44 (4.55%)  2
Neutrophil count decreased  1  9/44 (20.45%)  10
Platelet count decreased  1  10/44 (22.73%)  10
Serum cholesterol increased  1  1/44 (2.27%)  1
Metabolism and nutrition disorders   
Alkalosis  1  1/44 (2.27%)  1
Anorexia  1  3/44 (6.82%)  3
Blood glucose increased  1  10/44 (22.73%)  10
Blood uric acid increased  1  1/44 (2.27%)  2
Serum albumin decreased  1  6/44 (13.64%)  6
Serum calcium decreased  1  6/44 (13.64%)  6
Serum magnesium decreased  1  4/44 (9.09%)  4
Serum magnesium increased  1  2/44 (4.55%)  2
Serum phosphate decreased  1  2/44 (4.55%)  2
Serum potassium decreased  1  7/44 (15.91%)  7
Serum potassium increased  1  2/44 (4.55%)  2
Serum sodium decreased  1  3/44 (6.82%)  3
Serum sodium increased  1  1/44 (2.27%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/44 (2.27%)  1
Muscle weakness  1  1/44 (2.27%)  1
Muscle weakness right-sided  1  1/44 (2.27%)  1
Musculoskeletal disorder  1  1/44 (2.27%)  1
Pain in extremity  1  1/44 (2.27%)  1
Nervous system disorders   
Ataxia  1  3/44 (6.82%)  4
Cognitive disturbance  1  1/44 (2.27%)  1
Depressed level of consciousness  1  1/44 (2.27%)  1
Headache  1  2/44 (4.55%)  2
Intracranial hemorrhage  1  2/44 (4.55%)  2
Memory impairment  1  3/44 (6.82%)  5
Mini mental status examination abnormal  1  1/44 (2.27%)  1
Neurological disorder NOS  1  3/44 (6.82%)  3
Nystagmus  1  2/44 (4.55%)  2
Peripheral motor neuropathy  1  1/44 (2.27%)  1
Peripheral sensory neuropathy  1  1/44 (2.27%)  1
Seizure  1  1/44 (2.27%)  1
Speech disorder  1  1/44 (2.27%)  2
Psychiatric disorders   
Anxiety  1  1/44 (2.27%)  1
Confusion  1  4/44 (9.09%)  5
Depression  1  1/44 (2.27%)  1
Insomnia  1  1/44 (2.27%)  1
Renal and urinary disorders   
Renal failure  1  1/44 (2.27%)  1
Urinary retention  1  2/44 (4.55%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/44 (4.55%)  2
Dyspnea  1  1/44 (2.27%)  1
Epistaxis  1  2/44 (4.55%)  2
Hypoxia  1  1/44 (2.27%)  1
Pneumonitis  1  1/44 (2.27%)  1
Respiratory disorder  1  1/44 (2.27%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  1/44 (2.27%)  1
Decubitus ulcer  1  1/44 (2.27%)  1
Dry skin  1  1/44 (2.27%)  1
Rash desquamating  1  3/44 (6.82%)  3
Vascular disorders   
Hypertension  1  1/44 (2.27%)  1
Thrombosis  1  4/44 (9.09%)  4
Vascular disorder  1  1/44 (2.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intensive Combination Chemo & Immunotherapy
Affected / at Risk (%) # Events
Total   43/44 (97.73%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  7/44 (15.91%)  7
Hemoglobin decreased  1  30/44 (68.18%)  90
Cardiac disorders   
Arrhythmia  1  1/44 (2.27%)  1
Atrial fibrillation  1  1/44 (2.27%)  1
Atrial tachycardia  1  1/44 (2.27%)  1
Cardiac disorder  1  2/44 (4.55%)  4
Edema  1  1/44 (2.27%)  3
Palpitations  1  2/44 (4.55%)  3
Sinus bradycardia  1  3/44 (6.82%)  4
Sinus tachycardia  1  1/44 (2.27%)  1
Supraventricular tachycardia  1  1/44 (2.27%)  1
Ear and labyrinth disorders   
Ear pain  1  1/44 (2.27%)  1
Hearing impaired  1  2/44 (4.55%)  3
Endocrine disorders   
Cushingoid  1  1/44 (2.27%)  1
Eye disorders   
Diplopia  1  2/44 (4.55%)  5
Dry eye syndrome  1  2/44 (4.55%)  2
Eye disorder  1  3/44 (6.82%)  4
Eye pain  1  1/44 (2.27%)  1
Flashing vision  1  3/44 (6.82%)  3
Keratitis  1  1/44 (2.27%)  3
Photophobia  1  1/44 (2.27%)  1
Vision blurred  1  7/44 (15.91%)  16
Watering eyes  1  1/44 (2.27%)  1
Gastrointestinal disorders   
Abdominal pain  1  5/44 (11.36%)  5
Constipation  1  19/44 (43.18%)  37
Diarrhea  1  23/44 (52.27%)  45
Dry mouth  1  1/44 (2.27%)  6
Dyspepsia  1  6/44 (13.64%)  7
Flatulence  1  1/44 (2.27%)  1
Gastrointestinal disorder  1  2/44 (4.55%)  2
Mucositis oral  1  16/44 (36.36%)  22
Nausea  1  36/44 (81.82%)  92
Oral hemorrhage  1  1/44 (2.27%)  1
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in  1  1/44 (2.27%)  1
Typhlitis  1  1/44 (2.27%)  1
Vomiting  1  25/44 (56.82%)  44
General disorders   
Chest pain  1  3/44 (6.82%)  3
Chills  1  6/44 (13.64%)  7
Edema limbs  1  16/44 (36.36%)  36
Fatigue  1  32/44 (72.73%)  83
Fever  1  8/44 (18.18%)  9
General symptom  1  2/44 (4.55%)  2
Localized edema  1  1/44 (2.27%)  3
Pain  1  2/44 (4.55%)  2
Immune system disorders   
Hypersensitivity  1  2/44 (4.55%)  3
Infections and infestations   
Bladder infection  1  2/44 (4.55%)  2
Catheter related infection  1  3/44 (6.82%)  4
Eye infection  1  1/44 (2.27%)  1
Gingival infection  1  2/44 (4.55%)  3
Infection  1  4/44 (9.09%)  4
Infection with grade 3 or 4 neutropenia  1  1/44 (2.27%)  1
Infectious colitis  1  1/44 (2.27%)  1
Nail infection  1  1/44 (2.27%)  1
Opportunistic infection  1  1/44 (2.27%)  1
Phlebitis infective  1  1/44 (2.27%)  1
Pneumonia  1  1/44 (2.27%)  1
Sepsis  1  1/44 (2.27%)  1
Soft tissue infection  1  1/44 (2.27%)  1
Upper aerodigestive tract infection  1  1/44 (2.27%)  1
Upper respiratory infection  1  1/44 (2.27%)  1
Urinary tract infection  1  6/44 (13.64%)  6
Vaginal infection  1  1/44 (2.27%)  3
Wound infection  1  1/44 (2.27%)  1
Injury, poisoning and procedural complications   
Bruising  1  1/44 (2.27%)  1
Vascular access complication  1  2/44 (4.55%)  2
Investigations   
Activated partial thromboplastin time prolonged  1  1/44 (2.27%)  1
Alanine aminotransferase increased  1  32/44 (72.73%)  85
Alkaline phosphatase increased  1  8/44 (18.18%)  11
Aspartate aminotransferase increased  1  33/44 (75.00%)  81
Blood bilirubin increased  1  20/44 (45.45%)  32
Creatinine increased  1  17/44 (38.64%)  32
Fibrinogen decreased  1  1/44 (2.27%)  2
Gamma-glutamyltransferase increased  1  2/44 (4.55%)  3
Laboratory test abnormal  1  5/44 (11.36%)  7
Leukocyte count decreased  1  14/44 (31.82%)  39
Lymphocyte count decreased  1  3/44 (6.82%)  7
Neutrophil count decreased  1  31/44 (70.45%)  59
Platelet count decreased  1  30/44 (68.18%)  52
Serum cholesterol increased  1  2/44 (4.55%)  3
Weight gain  1  2/44 (4.55%)  3
Weight loss  1  3/44 (6.82%)  3
Metabolism and nutrition disorders   
Anorexia  1  19/44 (43.18%)  43
Blood glucose increased  1  19/44 (43.18%)  53
Blood uric acid increased  1  4/44 (9.09%)  6
Dehydration  1  5/44 (11.36%)  5
Serum albumin decreased  1  20/44 (45.45%)  41
Serum calcium decreased  1  14/44 (31.82%)  32
Serum glucose decreased  1  3/44 (6.82%)  5
Serum magnesium decreased  1  7/44 (15.91%)  13
Serum magnesium increased  1  2/44 (4.55%)  4
Serum phosphate decreased  1  4/44 (9.09%)  9
Serum potassium decreased  1  26/44 (59.09%)  68
Serum potassium increased  1  2/44 (4.55%)  3
Serum sodium decreased  1  15/44 (34.09%)  32
Serum sodium increased  1  4/44 (9.09%)  8
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/44 (6.82%)  3
Back pain  1  8/44 (18.18%)  9
Bone pain  1  2/44 (4.55%)  2
Muscle weakness  1  8/44 (18.18%)  13
Muscle weakness lower limb  1  2/44 (4.55%)  4
Myalgia  1  4/44 (9.09%)  6
Neck pain  1  1/44 (2.27%)  1
Pain in extremity  1  2/44 (4.55%)  4
Nervous system disorders   
Ataxia  1  15/44 (34.09%)  19
Cognitive disturbance  1  1/44 (2.27%)  1
Dizziness  1  10/44 (22.73%)  11
Dysgeusia  1  5/44 (11.36%)  10
Encephalopathy  1  1/44 (2.27%)  1
Facial nerve disorder  1  1/44 (2.27%)  6
Headache  1  21/44 (47.73%)  47
Intracranial hemorrhage  1  1/44 (2.27%)  1
Memory impairment  1  6/44 (13.64%)  12
Mini mental status examination abnormal  1  1/44 (2.27%)  1
Neurological disorder NOS  1  3/44 (6.82%)  3
Nystagmus  1  1/44 (2.27%)  2
Peripheral motor neuropathy  1  7/44 (15.91%)  17
Peripheral sensory neuropathy  1  11/44 (25.00%)  21
Seizure  1  4/44 (9.09%)  5
Speech disorder  1  3/44 (6.82%)  4
Syncope  1  1/44 (2.27%)  1
Tremor  1  3/44 (6.82%)  3
Trigeminal nerve disorder  1  1/44 (2.27%)  6
Psychiatric disorders   
Anxiety  1  11/44 (25.00%)  20
Confusion  1  13/44 (29.55%)  19
Depression  1  8/44 (18.18%)  16
Insomnia  1  9/44 (20.45%)  25
Psychosis  1  2/44 (4.55%)  2
Renal and urinary disorders   
Bladder spasm  1  1/44 (2.27%)  1
Glomerular filtration rate decreased  1  1/44 (2.27%)  1
Hemorrhage urinary tract  1  1/44 (2.27%)  1
Proteinuria  1  2/44 (4.55%)  2
Renal failure  1  1/44 (2.27%)  1
Urinary incontinence  1  2/44 (4.55%)  2
Urinary retention  1  1/44 (2.27%)  2
Urogenital disorder  1  3/44 (6.82%)  5
Reproductive system and breast disorders   
Vaginal hemorrhage  1  1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  2/44 (4.55%)  2
Cough  1  6/44 (13.64%)  7
Dyspnea  1  11/44 (25.00%)  19
Epistaxis  1  5/44 (11.36%)  7
Hiccups  1  3/44 (6.82%)  3
Hypoxia  1  1/44 (2.27%)  1
Laryngeal edema  1  1/44 (2.27%)  1
Nasal congestion  1  1/44 (2.27%)  1
Pharyngolaryngeal pain  1  1/44 (2.27%)  1
Pleural effusion  1  3/44 (6.82%)  4
Pneumonitis  1  5/44 (11.36%)  5
Respiratory disorder  1  1/44 (2.27%)  1
Voice alteration  1  7/44 (15.91%)  9
Skin and subcutaneous tissue disorders   
Alopecia  1  3/44 (6.82%)  4
Decubitus ulcer  1  1/44 (2.27%)  1
Dry skin  1  1/44 (2.27%)  1
Petechiae  1  1/44 (2.27%)  1
Pruritus  1  6/44 (13.64%)  7
Rash desquamating  1  21/44 (47.73%)  27
Skin disorder  1  3/44 (6.82%)  4
Vascular disorders   
Hemorrhage  1  1/44 (2.27%)  1
Hot flashes  1  1/44 (2.27%)  1
Hypertension  1  8/44 (18.18%)  13
Hypotension  1  4/44 (9.09%)  4
Phlebitis  1  1/44 (2.27%)  1
Thrombosis  1  3/44 (6.82%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: James Rubenstein, MD, PhD
Organization: University of California, San Francisco
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00098774     History of Changes
Other Study ID Numbers: CALGB-50202
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-50202
CDR0000398106 ( Registry Identifier: NCI Physician Data Query )
First Submitted: December 8, 2004
First Posted: December 9, 2004
Results First Submitted: June 26, 2014
Results First Posted: September 12, 2014
Last Update Posted: July 6, 2016