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NCT00795678 · ClinicalTrials.gov registry record
Chemotherapeutic Agents in Brain/Breast
A clinical trial, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- 10
- Enrollment target
NCT00795678: Completed study, sponsored by Case Comprehensive Cancer Center.
NCT00795678 is a clinical trial that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00795678 has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Studying samples of tumor tissue and blood from patients may help doctors understand how well these drugs can be carried to the brain. PURPOSE: More definitive knowledge of the penetration of chemotherapeutic and other agents into the brain is necessary for the future rational design of drug and drug regimens that target brain metastases. This clinical trial is studying how well capecitabine, cyclophosphamide, doxorubicin, gemcitabine, lapatinib, paclitaxel, trastuzumab, or vinorelbine penetrates brain tumors.
Primary Outcome
Serum/plasma concentrations: measured for all agents except trastuzumab by HPLC or LC-MS/MS. Trastuzumab concentrations measured by enzyme linked immunosorbent assay. Compared to tissue levels and the extent of change in serum/plasma during the surgical process will be noted. Tissue Concentrations: determined by HPLC/LC-MS/MS or by ELISA. The objective would be to compare tumor concentration to brain adjacent to tumor, which often has an intact BBB. The degree of BBB compromise in the specimens
Interventions
- DRUG cyclophosphamide
- DRUG capecitabine
- DRUG doxorubicin hydrochloride
- DRUG gemcitabine hydrochloride
- DRUG lapatinib ditosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-09 |
| Est. Completion | 2013-04 |
What the finished NCT00795678 record still lists
NCT00795678 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00795678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00795678 about?
NCT00795678 is a clinical study titled "Chemotherapeutic Agents in Brain/Breast". RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzum...
What is the current status of trial NCT00795678?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2008-09. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00795678?
The interventions under investigation include: cyclophosphamide (DRUG), capecitabine (DRUG), doxorubicin hydrochloride (DRUG), gemcitabine hydrochloride (DRUG), lapatinib ditosylate (DRUG).
Who is sponsoring clinical trial NCT00795678?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
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