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| Tracking Information | |||||
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| First Received Date ICMJE | November 3, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | January 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006433 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients With Chest Wall Recurrence or Stage IV Disease With Locally Advanced Breast Cancer | ||||
| Official Title ICMJE | |||||
| Brief Summary | Purpose: The purpose of this protocol is to evaluate the combination of Doxil chemotherapy and heat treatment for recurrent breast cancer located on the chestwall following mastectomy. This protocol also includes patients with metastatic breast cancer who have not had mastectomy but have advanced tumor remaining within the breast. Doxil is the drug adriamycin (also called doxorubicin) encapsulated in liposomes, which coats the drug with a small amount of lipid (fat). This chemotherapy is in a newer form which can be better delivered to the tumor tissue without causing as much systemic toxicity. We are combining heat treatment with this drug in an effort to further increase the delivery of drug to the tumor, which may give an increased tumor response. Methods: The patients will be treated with chemotherapy followed by heat treatment. This will be given for 6 cycles approximately every 4 weeks. For the first cycle patients will need to be hospitalized 3 days for measurement of blood levels of drug as well as some additional radiology studies which will help us to determine whether the drug is preferentially distributed within tumor. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006433 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NCRR-M01RR00030-0156, M01RR00030 | ||||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Center for Research Resources (NCRR) | ||||
| Verification Date | November 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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