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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00617539 |
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving irinotecan together with temozolomide and to see how well it works in treating patients with breast cancer who have received previous treatment for brain metastases.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Breast Cancer |
Drug: irinotecan hydrochloride Drug: temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Irinotecan and Temozolomide in Breast Cancer Patients With Brian Metastases That Have Progressed After Stereotactic Radiosurgery or Whole Brain Radiation |
Estimated Enrollment: | 37 |
Study Start Date: | February 2005 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive irinotecan IV on days 1 and 15 and oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 4 weeks.
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 with radiographically confirmed metastases to the brain
Must have demonstrated progression of brain metastases after prior treatment for brain metastases, including any of the following:
Disease progression in the CNS must meet ≥ 1 of the following criteria:
PATIENT CHARACTERISTICS:
No other active malignancy except for any of the following:
No other known contraindication to MRI including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 |
Principal Investigator: | Michelle Melisko, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000583265, UCSF-05751 |
Study First Received: | February 15, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00617539 History of Changes |
Health Authority: | Unspecified |
recurrent breast cancer stage IV breast cancer male breast cancer adult tumors metastatic to brain |
Skin Diseases Irinotecan Breast Neoplasms Central Nervous System Neoplasms Breast Cancer, Male Temozolomide Recurrence Camptothecin |
Breast Neoplasms, Male Neoplasm Metastasis Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Nervous System Neoplasms Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Nervous System Diseases Irinotecan Breast Neoplasms Enzyme Inhibitors Central Nervous System Neoplasms Temozolomide Pharmacologic Actions Camptothecin |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Nervous System Neoplasms Breast Diseases |