Chemotherapeutic Agents in Brain/Breast
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ClinicalTrials.gov Identifier: NCT00795678 |
Recruitment Status
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Completed
First Posted
: November 21, 2008
Last Update Posted
: August 2, 2013
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Tracking Information | |||||||
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First Submitted Date | November 20, 2008 | ||||||
First Posted Date | November 21, 2008 | ||||||
Last Update Posted Date | August 2, 2013 | ||||||
Study Start Date | September 2008 | ||||||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Concentration of drug [ Time Frame: Post-Op Per Sample Collection ] 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 will be assessed through analysis of serum protein levels and hemoglobin. |
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Original Primary Outcome Measures |
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Change History | Complete list of historical versions of study NCT00795678 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures | Not Provided | ||||||
Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Outcome Measures | Not Provided | ||||||
Original Other Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Chemotherapeutic Agents in Brain/Breast | ||||||
Official Title | Clinical Study to Assess Entry of Chemotherapeutic Agents Into Brain Metastases in Women With Breast Cancer | ||||||
Brief 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. |
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Detailed Description | OBJECTIVES:
OUTLINE: Patients are assigned to receive 1 of the 8 agents by the patient's treating oncologist. Patients receive a single dose of the following study drugs immediately preceding surgery: oral capecitabine; cyclophosphamide IV over 30 minutes; doxorubicin hydrochloride IV over 15 minutes; gemcitabine hydrochloride IV over 30 minutes; oral lapatinib ditosylate*; paclitaxel IV over 3 hours; trastuzumab (Herceptin®) IV over 30-90 minutes; or vinorelbine ditartrate IV over 10-30 minutes . Patients then undergo craniotomy for resection of the brain metastases. NOTE: *Patients receive oral lapatinib ditosylate at least 3 days prior to surgery and immediately before surgery. All patients receiving cyclophosphamide, doxorubicin hydrochloride, gemcitabine hydrochloride, paclitaxel, or vinorelbine ditartrate also receive a single dose of pegfilgrastim subcutaneously (SC) 24-48 hours after the study drug administration OR filgrastim (G-CSF) SC once daily for 10 days, beginning 24-48 hours after the study drug administration. Blood samples are collected periodically for pharmacological studies. Tissue samples obtained at surgical resection and blood samples are used to establish cell lines and analyzed for drug concentration by HPLC, LC-MS/MS or ELISA. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Retention: Samples With DNA Description: Collection of blood before and after chemotherapy is administered and before and after resection of tumor in the operating room. Analysis of small portions of the brain tumor obtained at the time of craniotomy for drug collection. |
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Sampling Method | Non-Probability Sample | ||||||
Study Population | Patients will be recruited from a population of breast cancer patients who are to undergo clinically indicated surgical resection of one of more symptomatic brain metastasis(es) treated at the investigational centers. | ||||||
Condition |
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Intervention |
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Study Groups/Cohorts | Not Provided | ||||||
Publications * | Morikawa A, Peereboom DM, Thorsheim HR, Samala R, Balyan R, Murphy CG, Lockman PR, Simmons A, Weil RJ, Tabar V, Steeg PS, Smith QR, Seidman AD. Capecitabine and lapatinib uptake in surgically resected brain metastases from metastatic breast cancer patients: a prospective study. Neuro Oncol. 2015 Feb;17(2):289-95. doi: 10.1093/neuonc/nou141. Epub 2014 Jul 11. Erratum in: Neuro Oncol. 2015 Oct;17(10):1423. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
10 | ||||||
Original Estimated Enrollment |
71 | ||||||
Actual Study Completion Date | April 2013 | ||||||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT00795678 | ||||||
Other Study ID Numbers | CASE4107 P30CA043703 ( U.S. NIH Grant/Contract ) CASE 4107 ( Other Identifier: Case Comprehensive Cancer Center ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Case Comprehensive Cancer Center | ||||||
Study Sponsor | Case Comprehensive Cancer Center | ||||||
Collaborators |
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Investigators |
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PRS Account | Case Comprehensive Cancer Center | ||||||
Verification Date | July 2013 |