Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148070
Status:
COMPLETED
Last Update Posted:
2012-10-05
First Post:
2005-09-02
Brief Title:
Phase II Study of Tailored-Dose Docetaxel in Metastatic Breast Cancer
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase II Study of Tailored-Dose Docetaxel in Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a research study which aims to improve the way that doctors determine the dose of chemotherapy given to patients Right now chemotherapy is determined by a patients height and weight However some patients metabolize chemotherapy faster or slower than the average person because of a different level of drug metabolizing enzyme in the liver Therefore some patients are either given too small or too large a dose of chemotherapy because the amount of enzyme is not taken into account This research study will examine the use of a simple test call the Erythromycin Breath TestERMBT to determine the amount of enzyme which can metabolize the chemotherapy drug docetaxel Taxotere The dose of docetaxel will be tailored to the amount of enzyme which is available to metabolize the drug for each patient
Detailed Description:
This is a research study which aims to improve the way that doctors determine the dose of chemotherapy given to patients Right now chemotherapy is determined by a patients height and weight However some patients metabolize chemotherapy faster or slower than the average person because of a different level of drug metabolizing enzyme in the liver Therefore some patients are either given too small or too large a dose of chemotherapy because the amount of enzyme is not taken into account This research study will examine the use of a simple test call the Erythromycin Breath TestERMBT to determine the amount of enzyme which can metabolize the chemotherapy drug docetaxel Taxotere The dose of docetaxel will be tailored to the amount of enzyme which is available to metabolize the drug for each patient Patients participating in this study will have biopsy proven measurable metastatic breast cancer
During the study
-Patients will receive tailored-dose docetaxel for their breast cancer
Approximately 45 subjects will be recruited at this site
Diagnosis and Staging
All patients will have primary tumor measurements by physical exam andor radiographic studies CT MRI bone scan
Erythromycin Breath Test The ERMBT will be administered in the outpatient setting prior to the first cycle of docetaxel Twenty minutes after the injection of a trace amount of 14C N-methyl erythromycin This test assesses the activity of the cytochrome P450 enzyme which is largely responsible for the metabolism of the chemotherapeutic agent docetaxelpatients will exhale through a tube creating bubbles in a solution of hyamine hydroxide ethanol and a blue indicator until 2 mmol of carbon dioxide has been trapped and the blue color vanishes
Premedications
Dexamethasone 8 mg po bid for three days beginning the day prior to docetaxel administration
Diphenhydramine 50 mg IVPB
Granisetron 2 mg po 30 minutes pre-docetaxel
Chemotherapy
Docetaxel tailored dose to be infused over 1 hour on day 1 every 3 weeks for the duration of study
Starting dose of docetaxel to be determined by the ERMBT and serum albumin according to formula as stated in protocol page 11
Suggested post-chemotherapy antiemetics
Compazine 10 mg po q 6 hours prn nauseavomiting
Pharmacokinetic Analysis
All patients will have pharmacokinetic determination with blood drawn for pharmacokinetic analysis over a 24 hour period after the first docetaxel treatment Time points include time 0 15 minutes 45 minutes 180 minutes 3 hours 390 minutes 65 hours and 1440 minutes 24 hours
DEXA Scan
DEXA scan will be performed during the patients stay in the Clinical Research Center on the Lunar DPXL Bone Densitometer This is a very simple and noninvasive test which uses x-rays and a computer program to analyze the ratio of 38 keV to 70 keV attenuation The program then calculates Fat and Lean values for the arms legs abdomen ribs and the total body This is the same test that is in widespread clinical use for the evaluation of osteoporosis During the DEXA scan patients will be exposed to a trace amount of radiation which is equal to about 2 of the yearly background dose or less
The amount of radiation to be administered by the erythromycin breath test and DEXA scan is not medically significant
After the first dose of docetaxel patients will receive docetaxel every 3 weeks
How long a patient continues on chemotherapy will be decided by both the patient and the doctor If a patient is responding to docetaxel typically they receive 6-8 doses
During the study
-Patients will receive tailored-dose docetaxel for their breast cancer
Approximately 45 subjects will be recruited at this site
Diagnosis and Staging
All patients will have primary tumor measurements by physical exam andor radiographic studies CT MRI bone scan
Erythromycin Breath Test The ERMBT will be administered in the outpatient setting prior to the first cycle of docetaxel Twenty minutes after the injection of a trace amount of 14C N-methyl erythromycin This test assesses the activity of the cytochrome P450 enzyme which is largely responsible for the metabolism of the chemotherapeutic agent docetaxelpatients will exhale through a tube creating bubbles in a solution of hyamine hydroxide ethanol and a blue indicator until 2 mmol of carbon dioxide has been trapped and the blue color vanishes
Premedications
Dexamethasone 8 mg po bid for three days beginning the day prior to docetaxel administration
Diphenhydramine 50 mg IVPB
Granisetron 2 mg po 30 minutes pre-docetaxel
Chemotherapy
Docetaxel tailored dose to be infused over 1 hour on day 1 every 3 weeks for the duration of study
Starting dose of docetaxel to be determined by the ERMBT and serum albumin according to formula as stated in protocol page 11
Suggested post-chemotherapy antiemetics
Compazine 10 mg po q 6 hours prn nauseavomiting
Pharmacokinetic Analysis
All patients will have pharmacokinetic determination with blood drawn for pharmacokinetic analysis over a 24 hour period after the first docetaxel treatment Time points include time 0 15 minutes 45 minutes 180 minutes 3 hours 390 minutes 65 hours and 1440 minutes 24 hours
DEXA Scan
DEXA scan will be performed during the patients stay in the Clinical Research Center on the Lunar DPXL Bone Densitometer This is a very simple and noninvasive test which uses x-rays and a computer program to analyze the ratio of 38 keV to 70 keV attenuation The program then calculates Fat and Lean values for the arms legs abdomen ribs and the total body This is the same test that is in widespread clinical use for the evaluation of osteoporosis During the DEXA scan patients will be exposed to a trace amount of radiation which is equal to about 2 of the yearly background dose or less
The amount of radiation to be administered by the erythromycin breath test and DEXA scan is not medically significant
After the first dose of docetaxel patients will receive docetaxel every 3 weeks
How long a patient continues on chemotherapy will be decided by both the patient and the doctor If a patient is responding to docetaxel typically they receive 6-8 doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRBMED 1999-121 | None | None | None |
| GIA11119 | None | None | None |