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PS-341 Alone and PS-341 Plus EPOCH Chemotherapy to Treat Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00054665
Recruitment Status : Completed
First Posted : February 6, 2003
Results First Posted : September 11, 2012
Last Update Posted : September 11, 2012
Sponsor:
Information provided by (Responsible Party):
Wyndham Wilson, National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition B-Cell Lymphoma
Interventions Drug: PS-341
Drug: Etoposide
Drug: Doxorubicin
Drug: Vincristine
Drug: Cyclophosphamide
Drug: Prednisone
Drug: Filgrastim
Enrollment 50
Recruitment Details  
Pre-assignment Details 1 patient was deemed ineligible and did not receive any treatment. In addition, per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators (e.g. participants can skip A)
Arm/Group Title Part A: PS-341 Alone Part B: PS-341 & EPOCH
Hide Arm/Group Description 1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators. PS-341 1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks. EPOCH (etoposide 50 mg/m^2 day continuous intravenous infusion days 1-4, doxorubicin 10 mg/m^2 day continuous intravenous infusion days 1-4, vincristine 0.4 mg/m^2/day continuous intravenous infusion days 1-4, cyclophosphamide 750 mg/m^2 intravenous bolus day 5, prednisone 60 mg/m^2 by mouth days 1-5, and filgrastim 300 micrograms subcutaneously day 6 to absolute neutrophil count (ANC) recovery >/= 5000/mm^3.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
Period Title: Part A
Started 23 [1] 0
Completed 23 0
Not Completed 0 0
[1]
5 participants only received Part A and 18 participants received Part B after Part A.
Period Title: Part B
Started 0 44 [1]
Completed 0 44
Not Completed 0 0
[1]
26 participants received only Part B
Arm/Group Title Arm A & B: PS-341 and PS-341 & EPOCH
Hide Arm/Group Description

Part A: PS-341 Alone

1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks Part B: PS-341 & EPOCH

PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.

EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
0
   0.0%
Between 18 and 65 years
36
  72.0%
>=65 years
14
  28.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
53.04  (16.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
14
  28.0%
Male
36
  72.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Hispanic or Latino
1
   2.0%
Not Hispanic or Latino
48
  96.0%
Unknown or Not Reported
1
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   8.0%
White
45
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Clinical Response Rate
Hide Description Clinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part A: PS-341 Alone Part B: PS-341 & EPOCH
Hide Arm/Group Description:
1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks

PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.

EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days.

Overall Number of Participants Analyzed 23 44
Measure Type: Number
Unit of Measure: Participants
Partial response 1 7
Complete response 0 8
2.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part A: PS-341 Alone Part B: PS-341 & EPOCH
Hide Arm/Group Description:
Part A: 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks

Part B:

PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.

EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days.

Overall Number of Participants Analyzed 23 44
Measure Type: Number
Unit of Measure: Participants
23 44
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A: PS-341 Alone Part B: PS-341 & EPOCH
Hide Arm/Group Description PS-341 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks

PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.

EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days.

All-Cause Mortality
Part A: PS-341 Alone Part B: PS-341 & EPOCH
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Part A: PS-341 Alone Part B: PS-341 & EPOCH
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/24 (87.50%)      40/44 (90.91%)    
Blood and lymphatic system disorders     
Hemoglobin  1  6/24 (25.00%)  18 17/44 (38.64%)  39
Leukocytes (total WBC)  1  7/24 (29.17%)  8 17/44 (38.64%)  43
Leukocytes (total WBC) for BMT studies, if specified in the protocol.  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Lymphopenia  1  5/24 (20.83%)  8 13/44 (29.55%)  25
Neutrophils/granulocytes (ANC/AGC)  1  5/24 (20.83%)  6 21/44 (47.73%)  41
Platelets  1  12/24 (50.00%)  27 33/44 (75.00%)  80
Transfusion: Platelets  1  1/24 (4.17%)  1 12/44 (27.27%)  22
Transfusion: pRBCs  1  1/24 (4.17%)  1 13/44 (29.55%)  19
Cardiac disorders     
Vasovagal episode  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Hypotension  1  4/24 (16.67%)  7 11/44 (25.00%)  13
Prolonged QTc interval (QTc > 0.48 seconds)  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Ear and labyrinth disorders     
Inner ear/hearing  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Eye disorders     
Ocular/Visual-Other (Specify, periorbital edema)  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Gastrointestinal disorders     
Anorexia  1  4/24 (16.67%)  4 8/44 (18.18%)  8
Constipation  1  1/24 (4.17%)  3 6/44 (13.64%)  6
Diarrhea patients without colostomy  1  7/24 (29.17%)  9 11/44 (25.00%)  16
Nausea  1  7/24 (29.17%)  8 12/44 (27.27%)  17
Stomatitis/pharyngitis (oral/pharyngeal mucositis)  1  2/24 (8.33%)  2 8/44 (18.18%)  14
Taste disturbance (dysgeusia)  1  3/24 (12.50%)  3 6/44 (13.64%)  6
Vomiting  1  1/24 (4.17%)  1 5/44 (11.36%)  7
Abdominal pain or cramping  1  3/24 (12.50%)  3 5/44 (11.36%)  6
Dehydration  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Dysphagia, esophagitis, odynophagia (painful swallowing)  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Flatulence  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Gastrointestinal-Other  1 [1]  0/24 (0.00%)  0 2/44 (4.55%)  2
Ileus (or neuroconstipation)  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Rectal bleeding/hematochezia  1  0/24 (0.00%)  0 2/44 (4.55%)  2
General disorders     
Edema  1  1/24 (4.17%)  1 5/44 (11.36%)  6
Fatigue (lethargy, malaise, asthenia)  1  8/24 (33.33%)  9 10/44 (22.73%)  14
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<  1  3/24 (12.50%)  3 3/44 (6.82%)  3
Rigors, chills  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Sweating (diaphoresis)  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Weight loss  1  0/24 (0.00%)  0 2/44 (4.55%)  2
Pain-Other (Specify, testicular)  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Constitutional Symptoms-Other (Specify, generalized weakness)  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Hepatobiliary disorders     
Alkaline phosphatase  1  1/24 (4.17%)  1 3/44 (6.82%)  5
Hypoalbuminemia  1  1/24 (4.17%)  1 9/44 (20.45%)  11
SGOT (AST) (serum glutamic oxaloacetic transaminase)  1  2/24 (8.33%)  4 4/44 (9.09%)  5
SGPT (ALT) (serum glutamic pyruvic transaminase)  1  3/24 (12.50%)  3 3/44 (6.82%)  4
Bilirubin  1  0/24 (0.00%)  0 3/44 (6.82%)  4
Immune system disorders     
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Infections and infestations     
Febrile neutropenia  1 [2]  0/24 (0.00%)  0 5/44 (11.36%)  6
Infection  1 [3]  0/24 (0.00%)  0 9/44 (20.45%)  12
Infection with unknown ANC  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Infection without neutropenia  1  0/24 (0.00%)  0 7/44 (15.91%)  13
Investigations     
Partial thromboplastin time (PTT)  1  3/24 (12.50%)  3 4/44 (9.09%)  5
Prothrombin time (PT)  1  1/24 (4.17%)  1 1/44 (2.27%)  1
Bicarbonate  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Metabolism and nutrition disorders     
Hypocalcemia  1  1/24 (4.17%)  1 4/44 (9.09%)  8
Hypoglycemia  1  1/24 (4.17%)  2 0/44 (0.00%)  0
Hypokalemia  1  1/24 (4.17%)  2 5/44 (11.36%)  6
Hypomagnesemia  1  2/24 (8.33%)  3 4/44 (9.09%)  6
Hyponatremia  1  1/24 (4.17%)  2 4/44 (9.09%)  5
Hyperglycemia  1  0/24 (0.00%)  0 10/44 (22.73%)  14
Hypermagnesemia  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Hyperuricemia  1  0/24 (0.00%)  0 3/44 (6.82%)  4
Hypophosphatemia  1  0/24 (0.00%)  0 2/44 (4.55%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia (joint pain)  1  1/24 (4.17%)  1 1/44 (2.27%)  1
Myalgia (muscle pain)  1  3/24 (12.50%)  4 1/44 (2.27%)  1
Muscle weakness (not due to neuropathy)  1  0/24 (0.00%)  0 7/44 (15.91%)  8
Bone pain  1  0/24 (0.00%)  0 3/44 (6.82%)  3
Chest pain (non-cardiac and non-pleuritic)  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Nervous system disorders     
Ataxia (incoordination)  1  1/24 (4.17%)  1 1/44 (2.27%)  1
Dizziness/lightheadedness  1  2/24 (8.33%)  3 4/44 (9.09%)  7
Neuropathy - motor  1  1/24 (4.17%)  1 2/44 (4.55%)  2
Neuropathy-sensory  1  5/24 (20.83%)  5 8/44 (18.18%)  10
Syncope (fainting)  1  1/24 (4.17%)  2 1/44 (2.27%)  1
Headache  1  1/24 (4.17%)  1 1/44 (2.27%)  1
Neuropathic pain  1 [4]  1/24 (4.17%)  4 1/44 (2.27%)  1
Neurology-Other (Specify)  1  0/24 (0.00%)  0 4/44 (9.09%)  4
Psychiatric disorders     
Insomnia  1  0/24 (0.00%)  0 3/44 (6.82%)  3
Mood alteration-anxiety agitation  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Renal and urinary disorders     
Creatinine  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  0/24 (0.00%)  0 1/44 (2.27%)  2
Dyspnea (shortness of breath)  1  0/24 (0.00%)  0 4/44 (9.09%)  5
Hiccoughs (hiccups, singultus)  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Hypoxia  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Pulmonary-Other (Specify, wheezing)  1  0/24 (0.00%)  0 2/44 (4.55%)  2
Skin and subcutaneous tissue disorders     
Bruising (in absence of grade 3 or 4 thrombocytopenia)  1  1/24 (4.17%)  2 0/44 (0.00%)  0
Rash/desquamation  1  3/24 (12.50%)  3 0/44 (0.00%)  0
Urticaria (hives, welts, wheals)  1  1/24 (4.17%)  2 0/44 (0.00%)  0
Nail changes  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Pruritus  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv2.0
[1]
tongue swollen rectal incontinence
[2]
(fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
[3]
(documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L)
[4]
(e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or painful neuropathies)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part A: PS-341 Alone Part B: PS-341 & EPOCH
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/24 (100.00%)      44/44 (100.00%)    
Blood and lymphatic system disorders     
Hemoglobin  1  5/24 (20.83%)  5 26/44 (59.09%)  40
Leukocytes (total WBC)  1  5/24 (20.83%)  5 25/44 (56.82%)  48
Lymphopenia  1  6/24 (25.00%)  8 14/44 (31.82%)  22
Neutrophils/granulocytes (ANC/AGC)  1  2/24 (8.33%)  2 26/44 (59.09%)  46
Platelets  1  4/24 (16.67%)  10 14/44 (31.82%)  26
Transfusion: pRBCs  1  1/24 (4.17%)  1 18/44 (40.91%)  21
Transfusion: Platelets  1  0/24 (0.00%)  0 3/44 (6.82%)  3
Cardiac disorders     
Phlebitis (superficial)  1  1/24 (4.17%)  1 1/44 (2.27%)  1
Sinus tachycardia  1  0/24 (0.00%)  0 4/44 (9.09%)  4
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)  1  0/24 (0.00%)  0 2/44 (4.55%)  2
Hypertension  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Hypotension  1  0/24 (0.00%)  0 4/44 (9.09%)  5
Pericardial effusion/pericarditis  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Thrombosis/embolism  1  0/24 (0.00%)  0 3/44 (6.82%)  3
Endocrine disorders     
Hot flashes/flushes  1  0/24 (0.00%)  0 2/44 (4.55%)  2
Eye disorders     
Dry eye  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Gastrointestinal disorders     
Anorexia  1  7/24 (29.17%)  7 7/44 (15.91%)  8
Constipation  1  7/24 (29.17%)  7 9/44 (20.45%)  13
Dehydration  1  1/24 (4.17%)  1 6/44 (13.64%)  7
Diarrhea patients without colostomy  1  3/24 (12.50%)  6 6/44 (13.64%)  6
Dyspepsia/heartburn  1  2/24 (8.33%)  2 2/44 (4.55%)  2
Flatulence  1  1/24 (4.17%)  1 4/44 (9.09%)  4
Mouth dryness  1  2/24 (8.33%)  2 1/44 (2.27%)  1
Nausea  1  2/24 (8.33%)  4 13/44 (29.55%)  15
Taste disturbance (dysgeusia)  1  2/24 (8.33%)  3 3/44 (6.82%)  3
Vomiting  1  3/24 (12.50%)  4 7/44 (15.91%)  9
Rectal bleeding/hematochezia  1  1/24 (4.17%)  1 1/44 (2.27%)  1
Abdominal pain or cramping  1  6/24 (25.00%)  9 7/44 (15.91%)  8
Dysphagia, esophagitis, odynophagia (painful swallowing)  1  0/24 (0.00%)  0 2/44 (4.55%)  2
Gastrointestinal-Other (Specify)  1 [1]  0/24 (0.00%)  0 3/44 (6.82%)  5
Stomatitis/pharyngitis (oral/pharyngeal mucositis)  1  0/24 (0.00%)  0 19/44 (43.18%)  26
General disorders     
Edema  1  6/24 (25.00%)  6 2/44 (4.55%)  3
Fatigue (lethargy, malaise, asthenia)  1  1/24 (4.17%)  1 10/44 (22.73%)  12
Fever  1 [2]  3/24 (12.50%)  4 9/44 (20.45%)  11
Weight gain  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Pain due to radiation  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Pain-Other (Specify)  1 [3]  1/24 (4.17%)  2 3/44 (6.82%)  3
Constitutional Symptoms-Other (Specify, disease progression)  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Rigors, chills  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Sweating (diaphoresis)  1  0/24 (0.00%)  0 2/44 (4.55%)  2
Weight loss  1  0/24 (0.00%)  0 6/44 (13.64%)  6
Hepatobiliary disorders     
Alkaline phosphatase  1  3/24 (12.50%)  3 4/44 (9.09%)  4
Hypoalbuminemia  1  3/24 (12.50%)  4 21/44 (47.73%)  25
Hyperglycemia  1  4/24 (16.67%)  6 15/44 (34.09%)  21
Bilirubin  1  0/24 (0.00%)  0 7/44 (15.91%)  7
SGOT (aspartate aminotransferase (AST)) (serum glutamic oxaloacetic transaminase)  1  0/24 (0.00%)  0 4/44 (9.09%)  4
Immune system disorders     
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  1/24 (4.17%)  1 2/44 (4.55%)  2
Infections and infestations     
Infection (documented clinically or microbiologically) with grade 3 or 4  1  1/24 (4.17%)  1 7/44 (15.91%)  9
Infection without neutropenia  1  5/24 (20.83%)  12 5/44 (11.36%)  6
Infection with unknown ANC  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Febrile neutropenia  1 [4]  0/24 (0.00%)  0 6/44 (13.64%)  7
Injury, poisoning and procedural complications     
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia  1  1/24 (4.17%)  1 1/44 (2.27%)  1
Hemorrhage-Other (Specify, L. eye)  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Investigations     
Prothrombin time (PT)  1  1/24 (4.17%)  1 3/44 (6.82%)  5
Partial thromboplastin time (PTT)  1  0/24 (0.00%)  0 8/44 (18.18%)  8
SGPT (alanine aminotransferase (ALT)) (serum glutamic pyruvic transaminase)  1  0/24 (0.00%)  0 9/44 (20.45%)  11
Bicarbonate  1  0/24 (0.00%)  0 1/44 (2.27%)  2
Metabolism and nutrition disorders     
Amylase  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Hypercalcemia  1  2/24 (8.33%)  2 2/44 (4.55%)  2
Hyperkalemia  1  2/24 (8.33%)  2 2/44 (4.55%)  3
Hypermagnesemia  1  1/24 (4.17%)  1 9/44 (20.45%)  13
Hypernatremia  1  1/24 (4.17%)  1 3/44 (6.82%)  3
Hypocalcemia  1  4/24 (16.67%)  5 16/44 (36.36%)  20
Hypoglycemia  1  3/24 (12.50%)  4 1/44 (2.27%)  1
Hypokalemia  1  1/24 (4.17%)  2 15/44 (34.09%)  24
Hypomagnesemia  1  2/24 (8.33%)  2 14/44 (31.82%)  20
Hyponatremia  1  1/24 (4.17%)  1 18/44 (40.91%)  24
Hypophosphatemia  1  0/24 (0.00%)  0 7/44 (15.91%)  8
Lipase  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Musculoskeletal and connective tissue disorders     
Muscle weakness (not due to neuropathy)  1  1/24 (4.17%)  1 2/44 (4.55%)  2
Bone pain  1  3/24 (12.50%)  4 8/44 (18.18%)  8
Chest pain (non-cardiac and non-pleuritic)  1  1/24 (4.17%)  1 2/44 (4.55%)  2
Myalgia (muscle pain)  1  5/24 (20.83%)  6 12/44 (27.27%)  14
Musculoskeletal-Other (Specify, degenerative changes-L. spine)  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Arthralgia (joint pain)  1  0/24 (0.00%)  0 6/44 (13.64%)  8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain (onset or exacerbation of tumor pain due to treatment)  1  2/24 (8.33%)  2 0/44 (0.00%)  0
Nervous system disorders     
Dizziness/lightheadedness  1  1/24 (4.17%)  1 4/44 (9.09%)  4
Insomnia  1  2/24 (8.33%)  2 4/44 (9.09%)  4
Neuropathy-sensory  1  2/24 (8.33%)  2 12/44 (27.27%)  13
Tremor  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Headache  1  2/24 (8.33%)  2 4/44 (9.09%)  4
Confusion  1  0/24 (0.00%)  0 2/44 (4.55%)  2
Depressed level of consciousness  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Neurologic-Other (Specify)  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Syncope (fainting)  1  0/24 (0.00%)  0 2/44 (4.55%)  2
Vertigo  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Neuropathic pain (e.g. jaw pain, neurologic pain, phantom pain, limb pain, post-infectious neuralgi  1  0/24 (0.00%)  0 2/44 (4.55%)  3
Psychiatric disorders     
Mood alteration-depression  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Renal and urinary disorders     
Dysuria (painful urination)  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Urinary frequency/urgency  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Creatinine  1  0/24 (0.00%)  0 6/44 (13.64%)  9
Incontinence  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Urinary retention  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Reproductive system and breast disorders     
Pelvic pain  1  2/24 (8.33%)  3 0/44 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  1/24 (4.17%)  1 0/44 (0.00%)  0
Cough  1  3/24 (12.50%)  4 4/44 (9.09%)  4
Dyspnea (shortness of breath)  1  3/24 (12.50%)  3 0/44 (0.00%)  0
Pleural effusion (non-malignant)  1  1/24 (4.17%)  1 3/44 (6.82%)  3
Apnea  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Dyspnea (shortness of breath)  1  0/24 (0.00%)  0 10/44 (22.73%)  11
Hiccoughs (hiccups, singultus)  1  0/24 (0.00%)  0 1/44 (2.27%)  2
Hypoxia  1  0/24 (0.00%)  0 4/44 (9.09%)  4
Pulmonary-Other (Specify, wheezing)  1  0/24 (0.00%)  0 2/44 (4.55%)  2
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)  1  0/24 (0.00%)  0 2/44 (4.55%)  2
Skin and subcutaneous tissue disorders     
Pruritus  1  1/24 (4.17%)  1 2/44 (4.55%)  2
Rash/desquamation  1  1/24 (4.17%)  1 4/44 (9.09%)  4
Alopecia  1  0/24 (0.00%)  0 6/44 (13.64%)  6
Nail changes  1  0/24 (0.00%)  0 1/44 (2.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv2.0
[1]
Abdominal bloating Abd. fullness Lost a filling on L. maxillary Tooth extraction
[2]
(in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
[3]
wisdom tooth testicular pain tooth pain low back
[4]
(fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Wyndham Wilson, M.D.
Organization: National Cancer Institute, National Institues of Health
Phone: 301-435-2415
EMail: wilsonw@mail.nih.gov
Layout table for additonal information
Responsible Party: Wyndham Wilson, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054665     History of Changes
Obsolete Identifiers: NCT00057902
Other Study ID Numbers: 030096
03-C-0096
First Submitted: February 5, 2003
First Posted: February 6, 2003
Results First Submitted: June 25, 2012
Results First Posted: September 11, 2012
Last Update Posted: September 11, 2012