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Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer

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ClinicalTrials.gov Identifier: NCT00069160
Recruitment Status : Completed
First Posted : September 16, 2003
Results First Posted : October 12, 2012
Last Update Posted : October 12, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lung Neoplasms
Ovarian Neoplasms
Cervix Neoplasms
Renal Neoplasms
Interventions Drug: docetaxel
Drug: tariquidar
Other: 99mTc-sestamibi imaging
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22 Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22
Hide Arm/Group Description Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose. Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
Period Title: Overall Study
Started 23 25
Completed 23 25
Not Completed 0 0
Arm/Group Title Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22 Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22 Total
Hide Arm/Group Description Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose. Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose. Total of all reporting groups
Overall Number of Baseline Participants 23 25 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  82.6%
20
  80.0%
39
  81.3%
>=65 years
4
  17.4%
5
  20.0%
9
  18.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 25 participants 48 participants
50.76  (9.54) 55.77  (9.57) 53.37  (9.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
Female
18
  78.3%
20
  80.0%
38
  79.2%
Male
5
  21.7%
5
  20.0%
10
  20.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 25 participants 48 participants
23 25 48
1.Primary Outcome
Title Geometric Mean of Maximum Concentration of the Drug (Cmax)
Hide Description In the first cycle patients were to receive docetaxel on days 1 and 8 and to be randomized to receive tariquidar on either day 1 or 8. Thus pharmacokinetic data with and without tariquidar can be compared.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Data were evaluable in 39 patients. Paired data from 31 participants were evaluable.
Arm/Group Title Docetaxel Alone With Tariquidar
Hide Arm/Group Description:
40 mg/m^2 docetaxel over 1 hour on days 1 and 8.
40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
Overall Number of Participants Analyzed 39 37
Geometric Mean (95% Confidence Interval)
Unit of Measure: Cmax (ng/mL)
C1D1
1315
(1081 to 1598)
1093
(791.2 to 1510)
C1D8
1060
(773.5 to 1452)
1026
(807.3 to 1303)
Both Groups (C1D1 + C1D8)
1190
(999.9 to 1416)
1063
(869.2 to 1301)
2.Primary Outcome
Title The Number of Participants With Adverse Events.
Hide Description Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 4 yrs 8-11 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22
Hide Arm/Group Description:
Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Unit of Measure: participants
23 25
3.Primary Outcome
Title Geometric Mean of Area Under Curve (AUC0)-24
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Pharmacokinetic data were evaluable in 39 patients. Paired data from 31 participants were evaluable.
Arm/Group Title Docetaxel Alone With Tariquidar
Hide Arm/Group Description:
40 mg/m^2 docetaxel over 1 hour on days 1 and 8.
40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
Overall Number of Participants Analyzed 39 37
Geometric Mean (95% Confidence Interval)
Unit of Measure: h*ng/mL
C1D1
1367
(1126 to 1658)
1409
(1172 to 1694)
C1D8
1308
(989.8 to 1730)
1327
(1084 to 1623)
Both Groups (C1D1 + C1D8)
1339
(1144 to 1568)
1373
(1206 to 1563)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel Alone, With Tariquidar
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Clinical Response Rate
Hide Description Response is determined by RECIST criteria defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesion. Lesions are either measurable or non-measurable. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/- 20 mm with conventional techniques (CT, MRI, xray) or as >/- 10 mm with a spiral CT scan. Non-measurable lesions are defined as all other lesions (or sites of disease) including small lesions (longest diameter <20 mm with conventional techniques or <10 mm using spiral CT.
Time Frame 4 years, 8-11 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Who Received Docetaxel and Tariquidar
Hide Arm/Group Description:
Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Percentage of participants
8
5.Secondary Outcome
Title Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar
Hide Description A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001. A secondary objective of this study was to establish whether tariquidar (150 mg) modulates Pgp in liver. Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. A baseline Tc-sestamibi scan was obtained before the administration of tariquidar. A minimum of 48 hours later, on or about day 22 a single dose of tariquidar was administered, followed by a second Tc-sestamibi scan.
Time Frame 3 - 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Percent increase in sestamibi AUC in liver after tariquidar.
Arm/Group Title All Patients Who Received Docetaxel and Tariquidar
Hide Arm/Group Description:
Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
Overall Number of Participants Analyzed 35
Median (Full Range)
Unit of Measure: percent increase in sestamibi AUC
82.2
(5.8 to 252)
6.Secondary Outcome
Title Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue
Hide Description 99mTc-sestamibi is a radionuclide imaging agent used to study cardiac function that has also been shown to be a substrate for P-glycoprotein- mediated drug efflux. Because of the high expression of Pgp in liver tissue, sestamibi uptake in liver tissue is often monitored as a marker of Pgp inhibition. A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001.
Time Frame 3-24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Who Received Docetaxel and Tariquidar
Hide Arm/Group Description:
Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
Overall Number of Participants Analyzed 31
Median (Full Range)
Unit of Measure: Percent
12.4
(7.2 to 24.1)
Time Frame 4 years and 11 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22
Hide Arm/Group Description Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose. Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
All-Cause Mortality
Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/23 (26.09%)      8/25 (32.00%)    
Cardiac disorders     
CARDIOVASCULAR (GENERAL):: Hypotension  1  0/23 (0.00%)  0 1/25 (4.00%)  1
CARDIOVASCULAR (GENERAL):: Thrombosis/embolism  1  0/23 (0.00%)  0 2/25 (8.00%)  2
Gastrointestinal disorders     
GASTROINTESTINAL:: Anorexia  1  0/23 (0.00%)  0 1/25 (4.00%)  1
HEMORRHAGE:: Rectal bleeding/hematochezia  1  0/23 (0.00%)  0 1/25 (4.00%)  1
General disorders     
CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)  1  1/23 (4.35%)  1 0/25 (0.00%)  0
CONSTITUTIONAL SYMPTOMS::  1 [1]  1/23 (4.35%)  1 2/25 (8.00%)  2
CONSTITUTIONAL SYMPTOMS:: Rigors, chills  1  1/23 (4.35%)  1 0/25 (0.00%)  0
Infections and infestations     
INFECTION/FEBRILE NEUTROPENIA:: Febrile neutropenia (fever of unknown origin without clinically or m  1  0/23 (0.00%)  0 1/25 (4.00%)  1
Investigations     
BLOOD/BONE MARROW:: Leukocytes (total WBC)  1  1/23 (4.35%)  1 1/25 (4.00%)  1
BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)  1  0/23 (0.00%)  0 1/25 (4.00%)  1
HEPATIC:: Alkaline phosphatase  1  0/23 (0.00%)  0 1/25 (4.00%)  1
HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)  1  0/23 (0.00%)  0 1/25 (4.00%)  1
HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)  1  0/23 (0.00%)  0 1/25 (4.00%)  1
Metabolism and nutrition disorders     
METABOLIC/LABORATORY:: Hyponatremia  1  0/23 (0.00%)  0 1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders     
MUSCULOSKELETAL:: Musculoskeletal-Other (Specify,musculoskeletal-lethargic)  1  1/23 (4.35%)  1 0/25 (0.00%)  0
MUSCULOSKELETAL:: Muscle weakness (not due to neuropathy)  1  0/23 (0.00%)  0 1/25 (4.00%)  1
Nervous system disorders     
NEUROLOGY:: Dizziness/lightheadedness  1  1/23 (4.35%)  1 0/25 (0.00%)  0
NEUROLOGY:: Depressed level of consciousness  1  0/23 (0.00%)  0 1/25 (4.00%)  1
NEUROLOGY:: Mood alteration-anxiety, agitation  1  0/23 (0.00%)  0 1/25 (4.00%)  1
Renal and urinary disorders     
Urinary frequency/urgency  1  0/23 (0.00%)  0 1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders     
PULMONARY:: Dyspnea (shortness of breath)  1  2/23 (8.70%)  2 3/25 (12.00%)  3
PULMONARY:: Pulmonary-Other (Specify,clinical deterioration)  1  1/23 (4.35%)  1 0/25 (0.00%)  0
PULMONARY:: Cough  1  0/23 (0.00%)  0 1/25 (4.00%)  1
Hypoxia  1  1/23 (4.35%)  1 1/25 (4.00%)  1
Pneumothorax  1  1/23 (4.35%)  1 1/25 (4.00%)  1
Skin and subcutaneous tissue disorders     
DERMATOLOGY/SKIN:: Alopecia  1  1/23 (4.35%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA10/CTCv2.0
[1]
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/23 (100.00%)      25/25 (100.00%)    
Blood and lymphatic system disorders     
BLOOD/BONE MARROW:: Hemoglobin  1  18/23 (78.26%)  130 21/25 (84.00%)  72
BLOOD/BONE MARROW:: Leukocytes (total WBC)  1  18/23 (78.26%)  86 21/25 (84.00%)  77
BLOOD/BONE MARROW:: Lymphopenia  1  2/23 (8.70%)  9 4/25 (16.00%)  21
BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)  1  19/23 (82.61%)  62 16/25 (64.00%)  41
BLOOD/BONE MARROW:: Platelets  1  7/23 (30.43%)  22 6/25 (24.00%)  31
BLOOD/BONE MARROW:: Transfusion: pRBCs  1  3/23 (13.04%)  5 9/25 (36.00%)  11
COAGULATION:: Partial thromboplastin time (PTT)  1  9/23 (39.13%)  17 6/25 (24.00%)  10
COAGULATION:: Prothrombin time (PT)  1  3/23 (13.04%)  6 4/25 (16.00%)  13
HEMORRHAGE:: CNS hemorrhage/bleeding  1  0/23 (0.00%)  0 1/25 (4.00%)  1
Cardiac disorders     
CARDIOVASCULAR (ARRHYTHMIA):: Sinus tachycardia  1  1/23 (4.35%)  1 0/25 (0.00%)  0
CARDIOVASCULAR (GENERAL):: Edema  1  7/23 (30.43%)  18 8/25 (32.00%)  8
CARDIOVASCULAR (GENERAL):: Hypertension  1  1/23 (4.35%)  1 0/25 (0.00%)  0
CARDIOVASCULAR (GENERAL):: Hypotension  1  2/23 (8.70%)  2 1/25 (4.00%)  1
CARDIOVASCULAR (GENERAL):: Phlebitis (superficial)  1  1/23 (4.35%)  1 0/25 (0.00%)  0
CARDIOVASCULAR (GENERAL):: Thrombosis/embolism  1  2/23 (8.70%)  3 1/25 (4.00%)  1
CARDIOVASCULAR (ARRHYTHMIA):: Palpitations  1  0/23 (0.00%)  0 1/25 (4.00%)  2
Ear and labyrinth disorders     
AUDITORY/HEARING:: Middle ear/hearing  1  1/23 (4.35%)  1 0/25 (0.00%)  0
PAIN:: Earache (otalgia)  1  0/23 (0.00%)  0 1/25 (4.00%)  1
Eye disorders     
OCULAR/VISUAL:: Conjunctivitis  1  2/23 (8.70%)  2 0/25 (0.00%)  0
OCULAR/VISUAL:: Dry eye  1  1/23 (4.35%)  1 0/25 (0.00%)  0
OCULAR/VISUAL:: Tearing (watery eyes)  1  9/23 (39.13%)  11 6/25 (24.00%)  10
OCULAR/VISUAL:: Ocular/Visual-Other (Specify,___)  1 [1]  0/23 (0.00%)  0 1/25 (4.00%)  1
OCULAR/VISUAL:: Vision-blurred vision  1  0/23 (0.00%)  0 2/25 (8.00%)  2
Gastrointestinal disorders     
GASTROINTESTINAL:: Anorexia  1  12/23 (52.17%)  21 13/25 (52.00%)  21
GASTROINTESTINAL:: Constipation  1  10/23 (43.48%)  13 4/25 (16.00%)  5
GASTROINTESTINAL:: Dehydration  1  1/23 (4.35%)  1 1/25 (4.00%)  1
GASTROINTESTINAL:: Diarrhea patients without colostomy  1  17/23 (73.91%)  33 17/25 (68.00%)  37
GASTROINTESTINAL:: Dyspepsia/heartburn  1  3/23 (13.04%)  5 2/25 (8.00%)  2
GASTROINTESTINAL:: Dysphagia, esophagitis, odynophagia (painful swallowing)  1  1/23 (4.35%)  1 1/25 (4.00%)  1
GASTROINTESTINAL:: Flatulence  1  1/23 (4.35%)  1 3/25 (12.00%)  3
GASTROINTESTINAL:: Gastrointestinal-Other (Specify,_____)  1 [2]  1/23 (4.35%)  1 0/25 (0.00%)  0
GASTROINTESTINAL:: Mouth dryness  1  1/23 (4.35%)  1 0/25 (0.00%)  0
GASTROINTESTINAL:: Nausea  1  13/23 (56.52%)  34 12/25 (48.00%)  19
GASTROINTESTINAL:: Stomatitis/pharyngitis (oral/pharyngeal mucositis)  1  7/23 (30.43%)  18 8/25 (32.00%)  13
GASTROINTESTINAL:: Taste disturbance (dysgeusia)  1  6/23 (26.09%)  11 10/25 (40.00%)  17
GASTROINTESTINAL:: Vomiting  1  10/23 (43.48%)  17 7/25 (28.00%)  8
GASTROINTESTINAL:: Mucositis due to radiation  1  0/23 (0.00%)  0 1/25 (4.00%)  1
GASTROINTESTINAL:: Nausea  1  0/23 (0.00%)  0 12/25 (48.00%)  19
HEMORRHAGE:: Rectal bleeding/hematochezia  1  0/23 (0.00%)  0 1/25 (4.00%)  1
General disorders     
CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)  1  18/23 (78.26%)  42 21/25 (84.00%)  56
CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<  1  6/23 (26.09%)  13 4/25 (16.00%)  5
CONSTITUTIONAL SYMPTOMS:: Rigors, chills  1  1/23 (4.35%)  1 0/25 (0.00%)  0
CONSTITUTIONAL SYMPTOMS:: Weight loss  1  3/23 (13.04%)  3 3/25 (12.00%)  3
PAIN:: Chest pain (non-cardiac and non-pleuritic)  1  4/23 (17.39%)  4 0/25 (0.00%)  0
Immune system disorders     
ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever)  1  0/23 (0.00%)  0 2/25 (8.00%)  3
ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  8/23 (34.78%)  9 3/25 (12.00%)  3
ALLERGY/IMMUNOLOGY:: Allergy-Other (Specify,_____)  1 [3]  0/23 (0.00%)  0 1/25 (4.00%)  1
Infections and infestations     
INFECTION/FEBRILE NEUTROPENIA:: Catheter-related infection  1  1/23 (4.35%)  1 0/25 (0.00%)  0
INFECTION/FEBRILE NEUTROPENIA::  1 [4]  3/23 (13.04%)  3 2/25 (8.00%)  2
INFECTION/FEBRILE NEUTROPENIA::  1 [5]  1/23 (4.35%)  1 1/25 (4.00%)  1
INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia  1  4/23 (17.39%)  7 5/25 (20.00%)  6
INFECTION/FEBRILE NEUTROPENIA:: Infection/Febrile Neutropenia-Other (Specify,____)  1 [6]  0/23 (0.00%)  0 1/25 (4.00%)  1
Investigations     
HEPATIC:: Alkaline phosphatase  1  7/23 (30.43%)  13 2/25 (8.00%)  2
HEPATIC:: Bilirubin  1  5/23 (21.74%)  14 3/25 (12.00%)  7
HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)  1  7/23 (30.43%)  11 1/25 (4.00%)  1
HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)  1  5/23 (21.74%)  6 2/25 (8.00%)  2
METABOLIC/LABORATORY:: CPK (creatine phosphokinase)  1  1/23 (4.35%)  1 1/25 (4.00%)  1
BLOOD/BONE MARROW:: Hemoglobin  1  0/23 (0.00%)  0 20/25 (80.00%)  72
METABOLIC/LABORATORY:: Hyperuricemia  1  1/23 (4.35%)  1 2/25 (8.00%)  3
Metabolism and nutrition disorders     
HEPATIC:: Hypoalbuminemia  1  16/23 (69.57%)  36 12/25 (48.00%)  40
METABOLIC/LABORATORY:: Bicarbonate  1  1/23 (4.35%)  1 0/25 (0.00%)  0
METABOLIC/LABORATORY:: Hypercalcemia  1  1/23 (4.35%)  2 1/25 (4.00%)  1
METABOLIC/LABORATORY:: Hyperglycemia  1  10/23 (43.48%)  26 11/25 (44.00%)  23
METABOLIC/LABORATORY:: Hyperkalemia  1  2/23 (8.70%)  2 3/25 (12.00%)  5
METABOLIC/LABORATORY:: Hypermagnesemia  1  3/23 (13.04%)  5 3/25 (12.00%)  4
METABOLIC/LABORATORY:: Hypernatremia  1  1/23 (4.35%)  1 0/25 (0.00%)  0
METABOLIC/LABORATORY:: Hypocalcemia  1  7/23 (30.43%)  20 7/25 (28.00%)  21
METABOLIC/LABORATORY:: Hypoglycemia  1  1/23 (4.35%)  1 0/25 (0.00%)  0
METABOLIC/LABORATORY:: Hypomagnesemia  1  8/23 (34.78%)  18 4/25 (16.00%)  6
METABOLIC/LABORATORY:: Hyponatremia  1  14/23 (60.87%)  36 15/25 (60.00%)  26
METABOLIC/LABORATORY:: Hypophosphatemia  1  3/23 (13.04%)  9 1/25 (4.00%)  1
METABOLIC/LABORATORY:: Hypokalemia  1  5/23 (21.74%)  6 3/25 (12.00%)  6
Musculoskeletal and connective tissue disorders     
MUSCULOSKELETAL:: Muscle weakness (not due to neuropathy)  1  1/23 (4.35%)  1 5/25 (20.00%)  7
PAIN:: Arthralgia (joint pain)  1  6/23 (26.09%)  9 6/25 (24.00%)  10
PAIN:: Bone pain  1  3/23 (13.04%)  5 4/25 (16.00%)  5
PAIN:: Myalgia (muscle pain)  1  7/23 (30.43%)  22 8/25 (32.00%)  12
Nervous system disorders     
NEUROLOGY:: Ataxia (incoordination)  1  1/23 (4.35%)  1 0/25 (0.00%)  0
NEUROLOGY:: Confusion  1  1/23 (4.35%)  2 1/25 (4.00%)  1
NEUROLOGY:: Depressed level of consciousness  1  1/23 (4.35%)  1 0/25 (0.00%)  0
NEUROLOGY:: Dizziness/lightheadedness  1  5/23 (21.74%)  5 3/25 (12.00%)  3
NEUROLOGY:: Extrapyramidal/involuntary movement/restlessness  1  1/23 (4.35%)  1 0/25 (0.00%)  0
NEUROLOGY:: Insomnia  1  4/23 (17.39%)  4 3/25 (12.00%)  3
NEUROLOGY:: Mood alteration-depression  1  2/23 (8.70%)  2 2/25 (8.00%)  2
NEUROLOGY:: Neuropathy-sensory  1  6/23 (26.09%)  7 8/25 (32.00%)  11
NEUROLOGY:: Seizure(s)  1  1/23 (4.35%)  1 0/25 (0.00%)  0
NEUROLOGY:: Syncope (fainting  1  1/23 (4.35%)  1 0/25 (0.00%)  0
NEUROLOGY:: Vertigo  1  1/23 (4.35%)  1 0/25 (0.00%)  0
PAIN:: Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralg  1  1/23 (4.35%)  1 0/25 (0.00%)  0
PAIN:: Pain-Other (Specify,___)  1 [7]  9/23 (39.13%)  11 2/25 (8.00%)  2
PAIN:: Headache  1  5/23 (21.74%)  5 5/25 (20.00%)  6
NEUROLOGY:: Mood alteration-anxiety, agitation  1  0/23 (0.00%)  0 1/25 (4.00%)  1
Renal and urinary disorders     
RENAL/GENITOURINARY:: Creatinine  1  2/23 (8.70%)  2 2/25 (8.00%)  3
RENAL/GENITOURINARY:: Urinary frequency/urgency  1  2/23 (8.70%)  2 1/25 (4.00%)  1
HEMORRHAGE:: Hematuria (in the absence of vaginal bleeding)  1  0/23 (0.00%)  0 1/25 (4.00%)  2
RENAL/GENITOURINARY:: Dysuria (painful urination)  1  0/23 (0.00%)  0 2/25 (8.00%)  2
RENAL/GENITOURINARY:: Urinary retention  1  0/23 (0.00%)  0 2/25 (8.00%)  2
Reproductive system and breast disorders     
PAIN:: Abdominal pain or cramping  1  5/23 (21.74%)  5 6/25 (24.00%)  8
PAIN:: Pelvic pain  1  0/23 (0.00%)  0 1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders     
HEMORRHAGE:: Epistaxis  1  2/23 (8.70%)  2 0/25 (0.00%)  0
PULMONARY:: Cough  1  9/23 (39.13%)  9 3/25 (12.00%)  3
PULMONARY:: Dyspnea (shortness of breath)  1  9/23 (39.13%)  10 7/25 (28.00%)  9
PULMONARY:: Pleural effusion (non-malignant)  1  2/23 (8.70%)  2 2/25 (8.00%)  5
PULMONARY:: Pulmonary-Other (Specify,___)  1 [8]  2/23 (8.70%)  3 0/25 (0.00%)  0
PULMONARY:: Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)  1  1/23 (4.35%)  1 0/25 (0.00%)  0
PULMONARY:: Hypoxia  1  2/23 (8.70%)  2 1/25 (4.00%)  1
Skin and subcutaneous tissue disorders     
DERMATOLOGY/SKIN:: Alopecia  1  8/23 (34.78%)  9 8/25 (32.00%)  10
DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify,_____)  1 [9]  1/23 (4.35%)  1 0/25 (0.00%)  0
DERMATOLOGY/SKIN:: Dry skin  1  3/23 (13.04%)  3 1/25 (4.00%)  1
DERMATOLOGY/SKIN:: Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)  1  1/23 (4.35%)  1 1/25 (4.00%)  1
DERMATOLOGY/SKIN:: Flushing  1  4/23 (17.39%)  7 1/25 (4.00%)  2
DERMATOLOGY/SKIN:: Hand-foot skin reaction  1  4/23 (17.39%)  5 3/25 (12.00%)  3
DERMATOLOGY/SKIN:: Injection site reaction  1  1/23 (4.35%)  1 5/25 (20.00%)  5
DERMATOLOGY/SKIN:: Nail changes  1  6/23 (26.09%)  9 8/25 (32.00%)  8
DERMATOLOGY/SKIN:: Radiation dermatitis  1  1/23 (4.35%)  1 0/25 (0.00%)  0
DERMATOLOGY/SKIN:: Rash/desquamation  1  4/23 (17.39%)  4 3/25 (12.00%)  4
DERMATOLOGY/SKIN:: Bruising (in absence of grade 3 or 4 thrombocytopenia)  1  0/23 (0.00%)  0 1/25 (4.00%)  1
DERMATOLOGY/SKIN:: Pruritus  1  0/23 (0.00%)  0 2/25 (8.00%)  2
DERMATOLOGY/SKIN:: Wound-non-infectious  1  0/23 (0.00%)  0 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA10/CTCv2.0
[1]
uveitis
[2]
gastrointestinal: tooth fracture
[3]
allergy:reaction to tariquidar
[4]
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0x10e9/L, fever >=38.5 degrees C)
[5]
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L)
[6]
infection-thrush
[7]
Back pain Hips + Legs pain-lumbar pain: back pain pain: sore throat pain: chest tube site pain: L flank lower pain: lower back pain pain: lower back
[8]
pleural effusion (malignant)
[9]
dermatology/skin: red peeling skin-face
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: Susan E. Bates, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-402-1357
EMail: BatesS@mail.nih.gov
Layout table for additonal information
Responsible Party: Susan E. Bates, National Cancer Institute (NCI), National Institutes of Health (NIH)
ClinicalTrials.gov Identifier: NCT00069160     History of Changes
Obsolete Identifiers: NCT00072202
Other Study ID Numbers: 030284
03-C-0284 ( Other Identifier: Clinical Center (CC), National Institutes of Health (NIH) )
030284 ( Other Identifier: Clinical Center (CC), National Institutes of Health (NIH) )
First Submitted: September 15, 2003
First Posted: September 16, 2003
Results First Submitted: June 30, 2011
Results First Posted: October 12, 2012
Last Update Posted: October 12, 2012