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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00765765 |
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help ixabepilone work better by making tumor cells more sensitive to the drug.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone given together with hydroxychloroquine and to see how well they work in treating patients with metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: hydroxychloroquine Drug: ixabepilone |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I/II Study of Ixabepilone in Combination With the Autophagy Inhibitor Hydroxychloroquine for the Treatment of Patients With Metastatic Breast Cancer |
Estimated Enrollment: | 51 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I dose-escalation study of ixabepilone followed by a phase II study.
During the first course, patients receive ixabepilone IV over 3 hours on day 1 and oral hydroxychloroquine twice daily on days 3-21. On all subsequent courses, patients receive ixabepilone IV over 3 hours on day 1 and oral hydroxychloroquine twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer
Anthracycline-resistant (or treated with minimum cumulative doxorubicin dose of 240 mg/m^2 or epirubicin dose of 360 mg/m^2) and taxane-resistant disease
PATIENT CHARACTERISTICS:
Total bilirubin ≤ upper limit of normal (ULN)
No other active malignancy
None of the following conditions within the past 6 months:
PRIOR CONCURRENT THERAPY:
Prior radiation to tumor sites allowed provided:
Responsible Party: | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Vassil Karantza-Wadsworth ) |
Study ID Numbers: | CDR0000615000, CINJ-040804, CINJ-0220080205 |
Study First Received: | October 2, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00765765 |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer male breast cancer |
Skin Diseases Breast Neoplasms, Male Epothilones Hydroxychloroquine |
Breast Neoplasms Breast Diseases Recurrence |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Pharmacologic Actions |
Antimalarials Neoplasms Antiparasitic Agents Neoplasms by Site Therapeutic Uses Tubulin Modulators Antirheumatic Agents |