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Trial record 92 of 448 for:    diphenhydramine

BMS 247550 to Treat Kidney Cancer

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: NCT00030992
Recruitment Status : Completed
First Posted : February 21, 2002
Results First Posted : July 20, 2012
Last Update Posted : August 20, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cell Carcinoma
Interventions Drug: BMS-247550
Drug: Ranitidine
Drug: Diphenhydramine
Enrollment 102
Recruitment Details 102 participants were enrolled in this study.
Pre-assignment Details  
Arm/Group Title BMS-247550
Hide Arm/Group Description One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
Period Title: Overall Study
Started 102
Completed 102
Not Completed 0
Arm/Group Title BMS-247550
Hide Arm/Group Description One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
Overall Number of Baseline Participants 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
<=18 years
0
   0.0%
Between 18 and 65 years
79
  77.5%
>=65 years
23
  22.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants
57.21  (10.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Female
24
  23.5%
Male
78
  76.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Hispanic or Latino
2
   2.0%
Not Hispanic or Latino
100
  98.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants
Caucasian 84
African American 12
Asian 5
Hispanic 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 102 participants
102
1.Primary Outcome
Title Response Rate
Hide Description Response rate is the percentage of participants with a response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions, Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BMS-247550
Hide Arm/Group Description:
One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: Percentage of participants
Complete response 1
Partial Response 9.4
Progressive disease 12.6
Stable disease 76.8
2.Secondary 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 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BMS-247550
Hide Arm/Group Description:
One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: Participants
99
Time Frame 10 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BMS-247550
Hide Arm/Group Description One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
All-Cause Mortality
BMS-247550
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
BMS-247550
Affected / at Risk (%) # Events
Total   40/102 (39.22%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1 [1]  2/102 (1.96%)  2
Hemoglobin (hgb)  1  4/102 (3.92%)  4
Hemorrhage/bleeding associated with surgery  1  1/102 (0.98%)  1
Cardiac disorders   
Cardiac left ventricular function  1  1/102 (0.98%)  1
Cardiac troponin T (cTnT)  1  1/102 (0.98%)  1
Cardiac-ischemia/infarction  1  1/102 (0.98%)  1
Circulatory or cardiac-Other (hypertension)  1  1/102 (0.98%)  1
CNS cerebrovascular ischemia  1  1/102 (0.98%)  1
Pericardial effusion/pericarditis  1  1/102 (0.98%)  1
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)  1  1/102 (0.98%)  1
Gastrointestinal disorders   
Diarrhea (without colostomy)  1  5/102 (4.90%)  5
Dysphagia, esophagitis, odynophagia (painful swallowing)  1  1/102 (0.98%)  1
Melena/GI bleeding  1  1/102 (0.98%)  1
Nausea  1  3/102 (2.94%)  3
Vomiting  1  1/102 (0.98%)  1
General disorders   
Edema  1  1/102 (0.98%)  1
Fatigue (lethargy, malaise, asthenia)  1  3/102 (2.94%)  3
Fever  1 [2]  8/102 (7.84%)  8
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  1/102 (0.98%)  1
Infections and infestations   
Catheter-related infection  1  1/102 (0.98%)  1
Infection  1 [3]  3/102 (2.94%)  3
Infection with neutropenia  1  1/102 (0.98%)  1
Infection without neutropenia  1  7/102 (6.86%)  7
Infection, Other (other than fever with neutropenia)  1  2/102 (1.96%)  2
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT  1  3/102 (2.94%)  3
Investigations   
Alkaline phosphatase  1  1/102 (0.98%)  1
CPK (creatine phosphokinase)  1  1/102 (0.98%)  1
Creatinine  1  2/102 (1.96%)  3
Hemoglobin increased  1  1/102 (0.98%)  1
Neutrophils/granulocytes (ANC/AGC)  1  5/102 (4.90%)  5
Platelet count decreased  1  1/102 (0.98%)  1
SGOT (AST)  1  1/102 (0.98%)  1
SGPT (ALT)  1  1/102 (0.98%)  1
Weight loss  1  1/102 (0.98%)  1
Metabolism and nutrition disorders   
Dehydration  1  6/102 (5.88%)  6
Hyperkalemia  1  2/102 (1.96%)  2
Hypertriglyceridemia  1  1/102 (0.98%)  1
Hyperuricemia  1  2/102 (1.96%)  2
Hypoalbuminemia  1  1/102 (0.98%)  1
Hypocalcemia  1  1/102 (0.98%)  1
Hypokalemia  1  2/102 (1.96%)  2
Hypomagnesemia  1  1/102 (0.98%)  1
Hyponatremia  1  2/102 (1.96%)  2
Musculoskeletal and connective tissue disorders   
Joint, muscle, or bone (osseous)-Other (fracture)  1  1/102 (0.98%)  2
Nervous system disorders   
Neurologic-Other (autonomic neuropathy)  1  2/102 (1.96%)  2
Neuropathic pain  1 [4]  1/102 (0.98%)  2
Neuropathy-motor  1  1/102 (0.98%)  1
Pain-neuropathic  1  1/102 (0.98%)  1
Seizure(s)  1  1/102 (0.98%)  1
Syncope  1  3/102 (2.94%)  3
Vasovagal reaction  1  1/102 (0.98%)  1
Renal and urinary disorders   
Acute kidney injury  1  1/102 (0.98%)  2
Hematuria (in the absence of vaginal bleeding)  1  3/102 (2.94%)  4
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome (ARDS)  1  1/102 (0.98%)  1
Dyspnea (shortness of breath)  1  6/102 (5.88%)  6
Hemoptysis  1  2/102 (1.96%)  2
Hypoxia  1  1/102 (0.98%)  1
Pleural effusion  1  1/102 (0.98%)  1
Pleural effusion (non-malignant)  1  1/102 (0.98%)  1
Pneumothorax  1  1/102 (0.98%)  1
Pulmonary-Other: malignant pleural effusion  1  1/102 (0.98%)  1
Voice changes/stridor/larynx  1 [5]  2/102 (1.96%)  2
Vascular disorders   
Hypotension  1  6/102 (5.88%)  6
Thrombosis/embolism  1  1/102 (0.98%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv2.0
[1]
(fever of unknown origin without clinically or microbiologically documented infection)
[2]
in the absence of neutropenia, where neutropenia is defined as AGC< 1.0x109/L
[3]
(documented clinically or microbiologically) with grade 3 or 4 neutropenia
[4]
e.g. jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or painful neuropathies
[5]
e.g. hoarseness, loss of voice, laryngitis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BMS-247550
Affected / at Risk (%) # Events
Total   99/102 (97.06%)    
Blood and lymphatic system disorders   
Anemia  1  12/102 (11.76%)  52
Blood and lymphatic system disorders-Other, specify (bruising)  1  1/102 (0.98%)  1
Febrile neutropenia  1 [1]  1/102 (0.98%)  1
Hemoglobin (hgb)  1  65/102 (63.73%)  235
Hemorrhage/bleeding associated with surgery  1  1/102 (0.98%)  1
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia  1  1/102 (0.98%)  1
Transfusion:pRBCs  1  2/102 (1.96%)  3
Cardiac disorders   
Cardiac-ischemia/infarction  1  1/102 (0.98%)  1
Circulatory or cardiac-Other (edema)  1  2/102 (1.96%)  2
Palpitation  1  1/102 (0.98%)  1
Sinus tachycardia  1  1/102 (0.98%)  1
Ear and labyrinth disorders   
Ear and labyrinth disorders-Other, specify (tinnitus)  1  1/102 (0.98%)  1
External auditory canal  1  1/102 (0.98%)  1
Middle ear/hearing  1  2/102 (1.96%)  2
Eye disorders   
Blurred vision  1  1/102 (0.98%)  1
Conjunctivitis  1  1/102 (0.98%)  1
Dry eye  1  1/102 (0.98%)  1
Eye disorders-Other, specify (blepharitis)  1  2/102 (1.96%)  2
Ocular-Other (blurred vision)  1  1/102 (0.98%)  1
Tearing (watery eyes)  1  3/102 (2.94%)  4
Vision-blurred vision  1  1/102 (0.98%)  1
Vision-flashing lights/floaters  1  1/102 (0.98%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/102 (0.98%)  1
Abdominal pain or cramping  1  12/102 (11.76%)  19
Constipation  1  30/102 (29.41%)  40
Depressed level of consciousness  1  1/102 (0.98%)  1
Diarrhea  1  4/102 (3.92%)  4
Diarrhea (without colostomy)  1  42/102 (41.18%)  95
Dyspepsia/heartburn  1  7/102 (6.86%)  7
Gastritis  1  2/102 (1.96%)  2
GI-Other (bloating)  1  2/102 (1.96%)  2
Nausea  1  48/102 (47.06%)  132
Salivary gland changes  1  1/102 (0.98%)  1
Vomiting  1  37/102 (36.27%)  66
General disorders   
Fatigue  1  13/102 (12.75%)  32
Chest pain (non-cardiac and non-pleuritic)  1  7/102 (6.86%)  9
Chills  1  2/102 (1.96%)  2
Edema  1  14/102 (13.73%)  19
Fatigue (lethargy, malaise, asthenia)  1  73/102 (71.57%)  220
Fever  1  2/102 (1.96%)  2
Fever (in absence of neutropenia, where neutropenia is defined as AGC<1.0x109/L)  1  30/102 (29.41%)  35
Pain  1  2/102 (1.96%)  2
Pain-Other (dysethesia)  1  17/102 (16.67%)  23
Rigors, chills  1  9/102 (8.82%)  10
Hepatobiliary disorders   
Bilirubin  1  6/102 (5.88%)  10
Blood bilirubin increased  1  4/102 (3.92%)  8
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  12/102 (11.76%)  16
Allergic rhinitis  1  1/102 (0.98%)  1
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  15/102 (14.71%)  19
Infections and infestations   
Catheter-related infection  1  3/102 (2.94%)  3
Infection without neutropenia  1  30/102 (29.41%)  41
Infection, Other (skin)  1  8/102 (7.84%)  8
Infections and infestations-Other, specify (skin)  1  4/102 (3.92%)  5
Stomatitis/pharyngitis (oral/pharyngeal mucositis)  1  10/102 (9.80%)  10
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT  1  9/102 (8.82%)  10
Injury, poisoning and procedural complications   
Bruising (in absence of grade 3 or 4 thrombocytopenia)  1  1/102 (0.98%)  1
Postoperative hemorrhage  1  1/102 (0.98%)  1
Wound dehiscence  1  1/102 (0.98%)  1
Wound-infectious  1  1/102 (0.98%)  1
Wound-non-infectious  1  1/102 (0.98%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  4/102 (3.92%)  12
Alanine aminotransferase increased  1  3/102 (2.94%)  5
Alkaline phosphokinase  1  24/102 (23.53%)  33
Alkaline phosphokinase increased  1  4/102 (3.92%)  6
Allergy-Other (rhinitis)  1  1/102 (0.98%)  1
Amylase  1  1/102 (0.98%)  2
Aspartate aminotransferase increased  1  6/102 (5.88%)  13
Cardiac troponin I increased  1  1/102 (0.98%)  1
Cholesterol high  1  1/102 (0.98%)  1
CPK (creatine phosphokinase)  1  4/102 (3.92%)  5
CPK increased  1  2/102 (1.96%)  4
Creatinine  1  15/102 (14.71%)  21
Creatinine increased  1  5/102 (4.90%)  14
Hemoglobin increased  1  1/102 (0.98%)  10
Hypercholesterolemia  1  2/102 (1.96%)  2
INR increased  1  4/102 (3.92%)  6
Leukocytes (total WBC)  1  34/102 (33.33%)  96
Lymphocyte count decreased  1  7/102 (6.86%)  30
Lymphocyte count increased  1  1/102 (0.98%)  1
Neutrophil count decreased  1  2/102 (1.96%)  2
Neutrophils/granulocytes (ANC/AGC)  1  46/102 (45.10%)  142
Partial thromboplastin time (PTT)  1  10/102 (9.80%)  14
Platelet count decreased  1  3/102 (2.94%)  6
Platelets  1  27/102 (26.47%)  72
SGOT (AST)  1  29/102 (28.43%)  48
SGPT (ALT)  1  19/102 (18.63%)  31
Weight loss  1  17/102 (16.67%)  20
White blood cell decreased  1  5/102 (4.90%)  15
Metabolism and nutrition disorders   
Acidosis  1  3/102 (2.94%)  3
Anorexia  1  56/102 (54.90%)  88
Dehydration  1  16/102 (15.69%)  22
Hypercalcemia  1  12/102 (11.76%)  18
Hyperglycemia  1  17/102 (16.67%)  28
Hyperkalemia  1  15/102 (14.71%)  24
Hypermagnesemia  1  6/102 (5.88%)  9
Hypernatremia  1  1/102 (0.98%)  1
Hypertriglyceridemia  1  10/102 (9.80%)  13
Hyperuricemia  1  9/102 (8.82%)  13
Hypoalbuminemia  1  62/102 (60.78%)  113
Hypocalcemia  1  12/102 (11.76%)  22
Hypokalemia  1  9/102 (8.82%)  15
Hypomagnesemia  1  19/102 (18.63%)  45
Hyponatremia  1  18/102 (17.65%)  37
Hypophosphatemia  1  8/102 (7.84%)  10
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/102 (1.96%)  2
Arthralgia (joint pain)  1  31/102 (30.39%)  49
Bone pain  1  1/102 (0.98%)  1
Generalized muscle weakness  1  1/102 (0.98%)  1
Joint, muscle, or bone (osseous)-Other (myalgia)  1  4/102 (3.92%)  4
Muscle weakness (not due to neuropathy)  1  4/102 (3.92%)  5
Myalgia (muscle ache)  1  14/102 (13.73%)  21
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain  1  3/102 (2.94%)  6
Tumor pain (onset or exacerbation of tumor pain due to treatment)  1  1/102 (0.98%)  1
Nervous system disorders   
Neuropathy-motor  1  2/102 (1.96%)  2
Dizziness  1  2/102 (1.96%)  2
Dizziness/lightheadedness  1  8/102 (7.84%)  9
Dysgeusia  1  2/102 (1.96%)  2
Extrapyramidal/involuntary movement/restlessness  1  3/102 (2.94%)  4
Headache  1  15/102 (14.71%)  21
Leukoencephalopathy  1  1/102 (0.98%)  1
Memory loss  1  1/102 (0.98%)  1
Nervous system disorders-Other, specify (vasovagal)  1  1/102 (0.98%)  1
Neurologic-Other (dizziness)  1  3/102 (2.94%)  3
Neuropathic pain  1 [2]  6/102 (5.88%)  9
Neuropathy-sensory  1  50/102 (49.02%)  88
Peripheral sensory neuropathy  1  5/102 (4.90%)  5
Sense of smell  1  1/102 (0.98%)  1
Syncope  1  2/102 (1.96%)  2
Taste disturbance (dysgeusia)  1  40/102 (39.22%)  86
Tremor  1  2/102 (1.96%)  3
Psychiatric disorders   
Confusion  1  1/102 (0.98%)  1
Depression  1  1/102 (0.98%)  1
Insomnia  1  13/102 (12.75%)  15
Mood alteration-anxiety agitation  1  3/102 (2.94%)  3
Mood alteration-depression  1  8/102 (7.84%)  10
Mood alteration-euphoria  1  1/102 (0.98%)  1
Renal and urinary disorders   
Dysuria (painful urination)  1  1/102 (0.98%)  1
Hematuria  1  1/102 (0.98%)  1
Hematuria (in the absence of vaginal bleeding)  1  6/102 (5.88%)  9
Incontinence  1  1/102 (0.98%)  1
Proteinuria  1  11/102 (10.78%)  11
Renal/GU-Other (urgency)  1  1/102 (0.98%)  1
Ureteral obstruction  1  1/102 (0.98%)  1
Urinary frequency  1  1/102 (0.98%)  1
Urinary frequency/urgency  1  1/102 (0.98%)  1
Urinary retention  1  1/102 (0.98%)  1
Reproductive system and breast disorders   
Vaginal bleeding  1  2/102 (1.96%)  3
Vaginal dryness  1  1/102 (0.98%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  29/102 (28.43%)  39
Dyspnea  1  5/102 (4.90%)  8
Epistaxis  1  6/102 (5.88%)  9
Hemoptysis  1  5/102 (4.90%)  6
Pleural effusion  1  1/102 (0.98%)  2
Pleuritic pain  1  2/102 (1.96%)  2
Postnasal drip  1  1/102 (0.98%)  1
Pericardial effusion/pericarditis  1  2/102 (1.96%)  2
Voice changes/stridor/larynx  1 [3]  1/102 (0.98%)  2
Dyspnea (shortness of breath)  1  19/102 (18.63%)  22
Skin and subcutaneous tissue disorders   
Alopecia  1  61/102 (59.80%)  76
Dermatitis, focal  1 [4]  1/102 (0.98%)  1
Dry skin  1  3/102 (2.94%)  3
Erythema multiforme  1 [5]  1/102 (0.98%)  1
Nail changes  1  37/102 (36.27%)  47
Nail discoloration  1  1/102 (0.98%)  1
Nail loss  1  1/102 (0.98%)  2
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  1/102 (0.98%)  1
Pruritis  1  2/102 (1.96%)  2
Rash/desquamation  1  12/102 (11.76%)  13
Skin-Other (dry skin)  1  2/102 (1.96%)  2
Sweating  1  5/102 (4.90%)  6
Vascular disorders   
Flushing  1  1/102 (0.98%)  1
Hot flashes/flashes  1  1/102 (0.98%)  1
Hypotension  1  6/102 (5.88%)  7
Phlebitis (superficial)  1  4/102 (3.92%)  4
Prothrombin time (PT)  1  5/102 (4.90%)  5
Thromboembolic event  1  1/102 (0.98%)  1
Thrombosis/embolism  1  1/102 (0.98%)  1
Hypertension  1  4/102 (3.92%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv2.0
[1]
fever of unknown origin without clinically or microbiologically documented infection
[2]
e.g. jaw pain, neurologic pain, phantom pain , post-infectious neuralgia, or painful neuropathies
[3]
e.g. hoarseness, loss of voice, laryngitis
[4]
associated with high-dose chemotherapy and bone marrow transplant
[5]
(e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis)
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
Name/Title: Tito Fojo, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-2631
Responsible Party: Antonio T. Fojo, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00030992     History of Changes
Obsolete Identifiers: NCT00033670
Other Study ID Numbers: 020130
02-C-0130
First Submitted: February 20, 2002
First Posted: February 21, 2002
Results First Submitted: June 6, 2012
Results First Posted: July 20, 2012
Last Update Posted: August 20, 2012