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

This study has been completed.

Study NCT00972205 Information provided by National Institutes of Health Clinical Center (CC)

First Received on September 3, 2009. Last Updated on January 3, 2012 History of Changes

Results First Received: September 20, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Cervical Ovarian Lung Breast Renal
Interventions:	Drug: paclitaxel Drug: CBT-1(Registered Trademark) Radiation: Tc 99m sestamibi

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Description

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.

Participant Flow: Overall Study

	Paclitaxel and CBT-1 to Treat Solid Tumors
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
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.

Description

Paclitaxel and CBT-1 to Treat Solid Tumors

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.

Baseline Measures

	Paclitaxel and CBT-1 to Treat Solid Tumors
Number of Participants [units: participants]	12
Age [units: participants]
<=18 years	0
Between 18 and 65 years	9
>=65 years	3
Age [units: years] Mean ± Standard Deviation	60.79 ± 9.50
Gender [units: participants]
Female	4
Male	8
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	0
Not Hispanic or Latino	12
Unknown or Not Reported	0
Race/Ethnicity, Customized [units: Participants]
White	11
Asian	1
Region of Enrollment [units: participants]
United States	12

Outcome Measures

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1. Primary:

Percent Increase in Sestamibi Retention in the Liver as a Measure of P-glycoprotein Inhibition [ Time Frame: sestamibi scanning was performed on day 0 and day 6, allowing scans to be performed pre and post CBT-1 administration ]

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2. Primary:

Number of Participants With Adverse Events [ Time Frame: 18 months ]

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3. Secondary:

Percent Inhibition of Rhodamine Efflux From CD56+Cells Post Treatment [ Time Frame: Rhodamine efflux was performed on blood drawn prior to CBT-1 ingestion and after 6 days of dosing. ]

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4. Secondary:

Number of Participants Who Had an Overall Response [ Time Frame: Baseline to progression ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Susan S. Bates, M.D.
Organization: National Cancer Institute (NCI), National Institutes of Health (NIH)
phone: 301-402-0984
e-mail: Batess@mail.nih.gov

No publications provided

ClinicalTrials.gov Identifier:	NCT00972205 History of Changes
Obsolete Identifiers:	NCT00658424
Other Study ID Numbers:	080035, 08-C-0035
Study First Received:	September 3, 2009
Results First Received:	September 20, 2011
Last Updated:	January 3, 2012
Health Authority:	United States: Federal Government