Trial Outcomes & Findings for Paclitaxel and CBT-1(Registered Trademark) to Treat Solid Tumors (NCT NCT00972205)
NCT ID: NCT00972205
Last Updated: 2012-07-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
sestamibi scanning was performed on day 0 and day 6, allowing scans to be performed pre and post CBT-1 administration
Results posted on
2012-07-19
Participant Flow
Participant milestones
| Measure |
Paclitaxel and CBT-1 to Treat Solid Tumors
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 Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paclitaxel and CBT-1(Registered Trademark) to Treat Solid Tumors
Baseline characteristics by cohort
| Measure |
Paclitaxel and CBT-1 to Treat Solid Tumors
n=12 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
|
Age Continuous
|
60.79 years
STANDARD_DEVIATION 9.50 • n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: sestamibi scanning was performed on day 0 and day 6, allowing scans to be performed pre and post CBT-1 administrationPopulation: As planned imaging data from 10 pts were analyzed.
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.
Outcome measures
| Measure |
Paclitaxel and CBT-1 to Treat Solid Tumors
n=10 Participants
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.
|
|---|---|
|
Percent Increase in Sestamibi Retention in the Liver as a Measure of P-glycoprotein Inhibition
|
71.9 percent increase sestamibi retention
Interval 34.7 to 100.8
|
PRIMARY outcome
Timeframe: 18 monthsHere are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Paclitaxel and CBT-1 to Treat Solid Tumors
n=12 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events
|
12 Participants
|
SECONDARY outcome
Timeframe: Rhodamine efflux was performed on blood drawn prior to CBT-1 ingestion and after 6 days of dosing.Population: 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.
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.
Outcome measures
| Measure |
Paclitaxel and CBT-1 to Treat Solid Tumors
n=12 Participants
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.
|
|---|---|
|
Percent Inhibition of Rhodamine Efflux From CD56+Cells Post Treatment
|
78 Percent inhibition of rhodamine efflux
Interval 51.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to progressionResponse 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.
Outcome measures
| Measure |
Paclitaxel and CBT-1 to Treat Solid Tumors
n=12 Participants
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.
|
|---|---|
|
Number of Participants Who Had an Overall Response
|
2 participants with response
|
Adverse Events
Paclitaxel and CBT-1 to Treat Solid Tumors
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel and CBT-1 to Treat Solid Tumors
n=12 participants at risk
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.
|
|---|---|
|
Infections and infestations
Infection (pneumonia)with normal absolute neutrophil count (ANC)
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Vascular disorders
Other: SVC (Superior vena cava) Syndrome
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Cardiac disorders
Pericardial Effusion
|
8.3%
1/12 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
Paclitaxel and CBT-1 to Treat Solid Tumors
n=12 participants at risk
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.
|
|---|---|
|
Investigations
ALKALINE PHOSPHATASE
|
50.0%
6/12 • Number of events 8 • 18 months
|
|
Immune system disorders
ALLERGIC REACTION
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
16.7%
2/12 • Number of events 3 • 18 months
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
25.0%
3/12 • Number of events 3 • 18 months
|
|
Investigations
ALT/SGPT
|
41.7%
5/12 • Number of events 10 • 18 months
|
|
Metabolism and nutrition disorders
ANOREXIA
|
50.0%
6/12 • Number of events 9 • 18 months
|
|
Investigations
AST/SGOT
|
66.7%
8/12 • Number of events 12 • 18 months
|
|
Nervous system disorders
ATAXIA
|
25.0%
3/12 • Number of events 4 • 18 months
|
|
Investigations
BICARBONATE, SERUM LOW
|
16.7%
2/12 • Number of events 3 • 18 months
|
|
Investigations
BILIRUBIN
|
33.3%
4/12 • Number of events 5 • 18 months
|
|
Eye disorders
BLURRED VISION
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Psychiatric disorders
CONFUSION
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
33.3%
4/12 • Number of events 5 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
33.3%
4/12 • Number of events 5 • 18 months
|
|
Investigations
CREATININE
|
8.3%
1/12 • Number of events 3 • 18 months
|
|
Gastrointestinal disorders
DIARRHEA
|
75.0%
9/12 • Number of events 16 • 18 months
|
|
Gastrointestinal disorders
DISTENTION
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Nervous system disorders
DIZZINESS
|
16.7%
2/12 • Number of events 3 • 18 months
|
|
Gastrointestinal disorders
DRY MOUTH
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
66.7%
8/12 • Number of events 9 • 18 months
|
|
General disorders
EDEMA, H&N
|
16.7%
2/12 • Number of events 2 • 18 months
|
|
General disorders
EDEMA, LIMB
|
25.0%
3/12 • Number of events 3 • 18 months
|
|
General disorders
FATIGUE
|
83.3%
10/12 • Number of events 17 • 18 months
|
|
General disorders
FEVER
|
25.0%
3/12 • Number of events 3 • 18 months
|
|
Vascular disorders
FLUSHING
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
HEARTBURN
|
25.0%
3/12 • Number of events 5 • 18 months
|
|
Infections and infestations
HEMOGLOBIN
|
100.0%
12/12 • Number of events 25 • 18 months
|
|
Renal and urinary disorders
HEMOGLOBINURIA
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
HEMORRHAGE-GI, UPPER GI NOS
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
100.0%
12/12 • Number of events 28 • 18 months
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Vascular disorders
HYPERTENSION
|
25.0%
3/12 • Number of events 3 • 18 months
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
25.0%
3/12 • Number of events 4 • 18 months
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
100.0%
12/12 • Number of events 17 • 18 months
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
25.0%
3/12 • Number of events 5 • 18 months
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
25.0%
3/12 • Number of events 4 • 18 months
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
58.3%
7/12 • Number of events 8 • 18 months
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
66.7%
8/12 • Number of events 11 • 18 months
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
50.0%
6/12 • Number of events 10 • 18 months
|
|
Vascular disorders
HYPOTENSION
|
25.0%
3/12 • Number of events 3 • 18 months
|
|
Endocrine disorders
HYPOTHYROIDISM
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Infections and infestations
INFECTION, URINARY TRACT NOS
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Investigations
INR
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Investigations
LEUKOCYTES
|
75.0%
9/12 • Number of events 14 • 18 months
|
|
Investigations
LYMPHOPENIA
|
16.7%
2/12 • Number of events 2 • 18 months
|
|
Psychiatric disorders
MOOD ALTERATION-ANXIETY
|
16.7%
2/12 • Number of events 2 • 18 months
|
|
Gastrointestinal disorders
MUCOSITIS (CLINICAL EXAM), ORAL CAVITY
|
16.7%
2/12 • Number of events 2 • 18 months
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
NAUSEA
|
83.3%
10/12 • Number of events 14 • 18 months
|
|
Nervous system disorders
NEUROPATHY-CRANIAL: CN-V MOTOR-JAW MUSCLES; SENSORY-FACIAL
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Nervous system disorders
NEUROPATHY-SENSORY
|
41.7%
5/12 • Number of events 5 • 18 months
|
|
Investigations
NEUTROPHILS
|
66.7%
8/12 • Number of events 12 • 18 months
|
|
Renal and urinary disorders
OTHER: DYSURIA
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Infections and infestations
OTHER: INFECTION NOS
|
16.7%
2/12 • Number of events 2 • 18 months
|
|
Investigations
OTHER: LDH
|
33.3%
4/12 • Number of events 4 • 18 months
|
|
Injury, poisoning and procedural complications
OTHER: PERFORATION NOS
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Cardiac disorders
OTHER: PULMONARY STENOSIS NOS
|
16.7%
2/12 • Number of events 2 • 18 months
|
|
Musculoskeletal and connective tissue disorders
OTHER: RUQ PAIN
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
PAIN, THROAT/PHARYNX/LARYNX
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
General disorders
PAIN NOS
|
16.7%
2/12 • Number of events 2 • 18 months
|
|
Gastrointestinal disorders
PAIN, ABD NOS
|
50.0%
6/12 • Number of events 8 • 18 months
|
|
Musculoskeletal and connective tissue disorders
PAIN, BACK
|
25.0%
3/12 • Number of events 3 • 18 months
|
|
Cardiac disorders
PAIN, CHEST/THORAX NOS
|
33.3%
4/12 • Number of events 4 • 18 months
|
|
Nervous system disorders
PAIN, HEAD/HEADACHE
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
PAIN, JOINT
|
50.0%
6/12 • Number of events 10 • 18 months
|
|
Musculoskeletal and connective tissue disorders
PAIN, MUSCLE
|
25.0%
3/12 • Number of events 4 • 18 months
|
|
Gastrointestinal disorders
PAIN, RECTUM
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAIN, TUMOR
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Investigations
PLATELETS
|
41.7%
5/12 • Number of events 9 • 18 months
|
|
Renal and urinary disorders
PROTEINURIA
|
50.0%
6/12 • Number of events 7 • 18 months
|
|
Skin and subcutaneous tissue disorders
PRURITIS
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Investigations
PTT
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
General disorders
RIGORS/CHILLS
|
16.7%
2/12 • Number of events 2 • 18 months
|
|
Gastrointestinal disorders
TASTE ALTERATION
|
16.7%
2/12 • Number of events 2 • 18 months
|
|
Renal and urinary disorders
URINARY RETENTION
|
16.7%
2/12 • Number of events 2 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
VOMITING
|
75.0%
9/12 • Number of events 12 • 18 months
|
|
Cardiac disorders
PLEURAL EFFUSION
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Psychiatric disorders
MOOD ALTERATION, DEPRESSION
|
8.3%
1/12 • Number of events 1 • 18 months
|
|
Vascular disorders
OTHER: LYMPHEDEMA
|
8.3%
1/12 • Number of events 1 • 18 months
|
Additional Information
Susan S. Bates, M.D.
National Cancer Institute (NCI), National Institutes of Health (NIH)
Phone: 301-402-0984
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place