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Paclitaxel and CBT-1(Registered Trademark) to Treat Solid Tumors

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ClinicalTrials.gov Identifier: NCT00972205
Recruitment Status : Completed
First Posted : September 4, 2009
Results First Posted : February 6, 2012
Last Update Posted : July 19, 2012
Sponsor:
Information provided by (Responsible Party):
Susan Bates, National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical
Ovarian
Lung
Breast
Renal
Interventions Drug: paclitaxel
Drug: CBT-1(Registered Trademark)
Radiation: Tc 99m sestamibi
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paclitaxel and CBT-1 to Treat Solid Tumors
Hide Arm/Group Description

Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.

Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle.

Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Paclitaxel and CBT-1 to Treat Solid Tumors
Hide Arm/Group Description

Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.

Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle.

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  75.0%
>=65 years
3
  25.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
60.79  (9.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
12
 100.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
White 11
Asian 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Percent Increase in Sestamibi Retention in the Liver as a Measure of P-glycoprotein Inhibition
Hide Description An area under the concentration curve (AUC) was calculated for 99mTc counts over the liver, lungs, and heart. An equation was applied to determine the increase in sestamibi in the liver: [(AUCpost - AUC baseline)/(AUC baseline)] x 100.
Time Frame sestamibi scanning was performed on day 0 and day 6, allowing scans to be performed pre and post CBT-1 administration
Hide Outcome Measure Data
Hide Analysis Population Description
As planned imaging data from 10 pts were analyzed.
Arm/Group Title Paclitaxel and CBT-1 to Treat Solid Tumors
Hide Arm/Group Description:

Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.

Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle.

Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: percent increase sestamibi retention
71.9
(34.7 to 100.8)
2.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paclitaxel and CBT-1 to Treat Solid Tumors
Hide Arm/Group Description:

Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.

Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Participants
12
3.Secondary Outcome
Title Percent Inhibition of Rhodamine Efflux From CD56+Cells Post Treatment
Hide Description Rhodamine 123 was added to whole blood obtained before and after CBT-1. The blood was incubated, layered on lymphocyte separation medium and centrifuged. Peripheral blood mononuclear cells(PBMCs)were isolated, washed and incubated in rhodamine-free medium with or without valspodar. Cells were washed and incubated in phycoerythrin-labeled anti-CD56 antibody or negative control antibody. Rhodamine 123 fluorescence was assessed in CD56+cells with or without valspodar and a 60 min efflux period,continuing the cells without or with valspodar to generate Efflux and PSC/Efflux histograms.
Time Frame Rhodamine efflux was performed on blood drawn prior to CBT-1 ingestion and after 6 days of dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
Rhodamine 123 fluorescence was assessed in CD56+cells after a 30 min loading period with or without exogenously added valspodar and a 60 min efflux period followed, continuing the cells with or without exogenous valspodar to generate Efflux and PSC/Efflux histograms. Percent decrease in difference between these histograms is reported.
Arm/Group Title Paclitaxel and CBT-1 to Treat Solid Tumors
Hide Arm/Group Description:

Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.

Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle.

Overall Number of Participants Analyzed 12
Mean (Full Range)
Unit of Measure: Percent inhibition of rhodamine efflux
78
(51 to 100)
4.Secondary Outcome
Title Number of Participants Who Had an Overall Response
Hide Description

Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR)-disappearance of all target lesions, Partial response (PR)-at least a 30% decrease in the sum of the longest diameter(LD)of target lesions, stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

See the Protocol Link module for further details about the RECIST Criteria.

Time Frame Baseline to progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paclitaxel and CBT-1 to Treat Solid Tumors
Hide Arm/Group Description:

Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.

Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants with response
2
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paclitaxel and CBT-1 to Treat Solid Tumors
Hide Arm/Group Description

Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.

Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle.

All-Cause Mortality
Paclitaxel and CBT-1 to Treat Solid Tumors
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Paclitaxel and CBT-1 to Treat Solid Tumors
Affected / at Risk (%) # Events
Total   3/12 (25.00%)    
Cardiac disorders   
Pericardial Effusion  1  1/12 (8.33%)  1
Infections and infestations   
Infection (pneumonia)with normal absolute neutrophil count (ANC)  1  1/12 (8.33%)  1
Vascular disorders   
Other: SVC (Superior vena cava) Syndrome  1  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paclitaxel and CBT-1 to Treat Solid Tumors
Affected / at Risk (%) # Events
Total   12/12 (100.00%)    
Cardiac disorders   
OTHER: PULMONARY STENOSIS NOS  1  2/12 (16.67%)  2
PAIN, CHEST/THORAX NOS  1  4/12 (33.33%)  4
PLEURAL EFFUSION  1  1/12 (8.33%)  1
Endocrine disorders   
HYPOTHYROIDISM  1  1/12 (8.33%)  1
Eye disorders   
BLURRED VISION  1  1/12 (8.33%)  1
Gastrointestinal disorders   
CONSTIPATION  1  4/12 (33.33%)  5
DIARRHEA  1  9/12 (75.00%)  16
DISTENTION  1  1/12 (8.33%)  1
DRY MOUTH  1  1/12 (8.33%)  1
HEARTBURN  1  3/12 (25.00%)  5
HEMORRHAGE-GI, UPPER GI NOS  1  1/12 (8.33%)  1
MUCOSITIS (CLINICAL EXAM), ORAL CAVITY  1  2/12 (16.67%)  2
NAUSEA  1  10/12 (83.33%)  14
PAIN, THROAT/PHARYNX/LARYNX  1  1/12 (8.33%)  1
PAIN, ABD NOS  1  6/12 (50.00%)  8
PAIN, RECTUM  1  1/12 (8.33%)  1
TASTE ALTERATION  1  2/12 (16.67%)  2
VOMITING  1  9/12 (75.00%)  12
General disorders   
EDEMA, H&N  1  2/12 (16.67%)  2
EDEMA, LIMB  1  3/12 (25.00%)  3
FATIGUE  1  10/12 (83.33%)  17
FEVER  1  3/12 (25.00%)  3
PAIN NOS  1  2/12 (16.67%)  2
RIGORS/CHILLS  1  2/12 (16.67%)  2
Immune system disorders   
ALLERGIC REACTION  1  1/12 (8.33%)  1
Infections and infestations   
HEMOGLOBIN  1  12/12 (100.00%)  25
INFECTION, URINARY TRACT NOS  1  1/12 (8.33%)  1
OTHER: INFECTION NOS  1  2/12 (16.67%)  2
Injury, poisoning and procedural complications   
OTHER: PERFORATION NOS  1  1/12 (8.33%)  1
Investigations   
ALKALINE PHOSPHATASE  1  6/12 (50.00%)  8
ALT/SGPT  1  5/12 (41.67%)  10
AST/SGOT  1  8/12 (66.67%)  12
BICARBONATE, SERUM LOW  1  2/12 (16.67%)  3
BILIRUBIN  1  4/12 (33.33%)  5
CREATININE  1  1/12 (8.33%)  3
INR  1  1/12 (8.33%)  1
LEUKOCYTES  1  9/12 (75.00%)  14
LYMPHOPENIA  1  2/12 (16.67%)  2
NEUTROPHILS  1  8/12 (66.67%)  12
OTHER: LDH  1  4/12 (33.33%)  4
PLATELETS  1  5/12 (41.67%)  9
PTT  1  1/12 (8.33%)  1
Metabolism and nutrition disorders   
ANOREXIA  1  6/12 (50.00%)  9
HYPERCALCEMIA  1  1/12 (8.33%)  1
HYPERGLYCEMIA  1  12/12 (100.00%)  28
HYPERKALEMIA  1  1/12 (8.33%)  1
HYPERURICEMIA  1  3/12 (25.00%)  4
HYPOALBUMINEMIA  1  12/12 (100.00%)  17
HYPOCALCEMIA  1  3/12 (25.00%)  5
HYPOGLYCEMIA  1  1/12 (8.33%)  1
HYPOKALEMIA  1  3/12 (25.00%)  4
HYPOMAGNESEMIA  1  7/12 (58.33%)  8
HYPONATREMIA  1  8/12 (66.67%)  11
HYPOPHOSPHATEMIA  1  6/12 (50.00%)  10
HYPERMAGNESEMIA  1  1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders   
OTHER: RUQ PAIN  1  1/12 (8.33%)  1
PAIN, BACK  1  3/12 (25.00%)  3
PAIN, JOINT  1  6/12 (50.00%)  10
PAIN, MUSCLE  1  3/12 (25.00%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
PAIN, TUMOR  1  1/12 (8.33%)  1
Nervous system disorders   
ATAXIA  1  3/12 (25.00%)  4
DIZZINESS  1  2/12 (16.67%)  3
NEUROPATHY-CRANIAL: CN-V MOTOR-JAW MUSCLES; SENSORY-FACIAL  1  1/12 (8.33%)  1
NEUROPATHY-SENSORY  1  5/12 (41.67%)  5
PAIN, HEAD/HEADACHE  1  1/12 (8.33%)  1
Psychiatric disorders   
CONFUSION  1  1/12 (8.33%)  1
MOOD ALTERATION-ANXIETY  1  2/12 (16.67%)  2
MOOD ALTERATION, DEPRESSION  1  1/12 (8.33%)  1
Renal and urinary disorders   
HEMOGLOBINURIA  1  1/12 (8.33%)  1
OTHER: DYSURIA  1  1/12 (8.33%)  1
PROTEINURIA  1  6/12 (50.00%)  7
URINARY RETENTION  1  2/12 (16.67%)  2
Respiratory, thoracic and mediastinal disorders   
ALLERGIC RHINITIS  1  2/12 (16.67%)  3
COUGH  1  4/12 (33.33%)  5
DYSPNEA  1  8/12 (66.67%)  9
VOICE CHANGES  1  1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
ALOPECIA  1  3/12 (25.00%)  3
HYPERPIGMENTATION  1  1/12 (8.33%)  1
NAIL CHANGES  1  1/12 (8.33%)  1
PRURITIS  1  1/12 (8.33%)  1
DRY SKIN  1  1/12 (8.33%)  1
Vascular disorders   
FLUSHING  1  1/12 (8.33%)  1
HYPERTENSION  1  3/12 (25.00%)  3
HYPOTENSION  1  3/12 (25.00%)  3
OTHER: LYMPHEDEMA  1  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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 S. Bates, M.D.
Organization: National Cancer Institute (NCI), National Institutes of Health (NIH)
Phone: 301-402-0984
EMail: Batess@mail.nih.gov
Layout table for additonal information
Responsible Party: Susan Bates, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00972205    
Obsolete Identifiers: NCT00658424
Other Study ID Numbers: 080035
08-C-0035
First Submitted: September 3, 2009
First Posted: September 4, 2009
Results First Submitted: September 20, 2011
Results First Posted: February 6, 2012
Last Update Posted: July 19, 2012