Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00346229 |
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Giving temperature-sensitive liposomal doxorubicin together with hyperthermia may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of temperature-sensitive liposomal doxorubicin when given together with hyperthermia in treating women with locally recurrent breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: filgrastim Drug: lyso-thermosensitive liposome doxorubicin Drug: pegfilgrastim Procedure: hyperthermia treatment |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I, Dose Escalation and Pharmacokinetics Study of Temperature Sensitive Liposome Encapsulated Doxorubicin (ThermoDox™) and Hyperthermia in Patients With Local-Regionally Recurrent Breast Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | April 2006 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of temperature-sensitive liposomal doxorubicin (ThermoDox™).
Patients receive ThermoDox™ IV over 30 minutes immediately followed by hyperthermia to the chest wall/axilla over 1-2 hours on day 1. Treatment repeats every 21-35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ThermoDox™ (with or without standard-dose granulocyte colony-stimulating factor [G-CSF] support) until the maximum tolerated dose (MTD) is determined. The MTD without G-CSF support is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). At least 6 patients are treated at the MTD. If the only DLT is neutropenia in > 1 of 6 patients treated at any dose level, then additional cohorts of 3-6 patients receive escalating doses of ThermoDox™ with G-CSF support (standard-dose G-CSF or standard-dose pegfilgrastim) until the MTD is determined. The MTD with G-CSF support is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT after the addition of G-CSF support.
Quality of life and pain are assessed at baseline, prior to courses 3 and 5, and at 21-42 days after completion of therapy.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
Locally recurrent disease involving the chest wall and/or its overlying skin
Distant metastasis (excluding known brain metastases) allowed
PATIENT CHARACTERISTICS:
No history of any of the following:
No other serious medical illness including, but not limited to, the following:
No concurrent devices or conditions that might interfere with the hyperthermia portion of the trial, including any of the following:
PRIOR CONCURRENT THERAPY:
No prior therapy with anthracyclines exceeding the following doses:
No concurrent administration of any of the following drugs:
United States, North Carolina | |
Duke Comprehensive Cancer Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 |
Principal Investigator: | Kimberly L. Blackwell, MD | Duke University |
Study ID Numbers: | CDR0000482411, DUMC-6883-06-2R1, DUMC-06068 |
Study First Received: | June 28, 2006 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00346229 |
Health Authority: | Unspecified |
stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer inflammatory breast cancer recurrent breast cancer |
Fever Inflammatory breast cancer Skin Diseases Breast Neoplasms |
Doxorubicin Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |