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| Sponsor: | National Taiwan University Hospital |
|---|---|
| Collaborators: |
Taipei Veterans General Hospital,Taiwan Taichung Veterans General Hospital |
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01281696 |
Purpose
The main purpose of this study is to investigate the efficacy of bevacizumab, etoposide and cisplatin in treating breast cancer patients with central nervous system metastasis (including brain parenchymal and leptomeningeal metastasis).
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms Metastatic Malignant Neoplasm to the Leptomeninges Metastatic Malignant Neoplasm to Brain |
Drug: Bevacizumab, etoposide, cisplatin Drug: Intrathecal methotrexate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients With Brain and/or Leptomeningeal Metastasis |
The response criteria for brain parenchymal metastasis is measured according to the volumetric response criteria with modification. CNS lesion(s) which have a ≧ 50% volumetric reduction of in the absence of progressive neurologic signs and symptoms will be considered as responsive.
The response criteria for leptomeningeal metastasis is defined as disappearance of carcinoma cells of three consecutive cytology examination of cerebrospinal fluid (CSF) after chemotherapy. For patients with both brain and leptomeningeal metastases, both criteria need to be met to be considered as responsive.
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bevacizumab, etoposide, cisplatin (B-EP) |
Drug: Bevacizumab, etoposide, cisplatin
Bevacizumab (15mg/kg) on D1, etoposide (70mg/m2) on D2-D4, cisplatin (70mg/m2) on D2; 21 days a cycle, for a maximum of 6 cycles
Other Name: Bevacizumab (Avastin)
Drug: Intrathecal methotrexate
Additional intrathecal methotrexate only given in patients with leptomeningeal metastasis
Other Name: Methotrexate
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have adequate organ and marrow reserve measured within 14 days prior to randomization as defined below:
Exclusion criteria:
Contacts and Locations| Contact: Yen-Shen Lu, MD, PhD | 886-2-23123456 ext 67009 | yslu@ntu.edu.tw |
| Contact: Ching-Hung Lin, MD | 886-2-23123456 ext 67513 | chinghlin@ntu.edu.tw |
| Taiwan | |
| Department of Oncology, National Taiwan University Hospital | Recruiting |
| Taipei City, Taiwan, 100 | |
| Contact: Yen-Shen Lu, MD, PhD 886-2-23123456 ext 67009 yslu@ntu.edu.tw | |
| Principal Investigator: Yen-Shen Lu, MD, PhD | |
| Principal Investigator: | Yen-Shen Lu, MD, PhD | Department of Oncology, National Taiwan University Hospital |
More Information
| Responsible Party: | Dr. Yen-Shen Lu, Department of Oncology, National Taiwan Univeristy Hospital |
| ClinicalTrials.gov Identifier: | NCT01281696 History of Changes |
| Other Study ID Numbers: | 201010077M |
| Study First Received: | December 24, 2010 |
| Last Updated: | March 8, 2011 |
| Health Authority: | Taiwan: Department of Health |
|
Breast cancer CNS metastasis Brain metastasis Leptomeningeal metastasis |
Bevacizumab Etoposide Cisplatin |
|
Breast Neoplasms Neoplasms Neoplasm Metastasis Brain Neoplasms Meningeal Carcinomatosis Neoplasms, Second Primary Neoplasms by Site Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Meningeal Neoplasms Etoposide phosphate Bevacizumab Cisplatin Etoposide Methotrexate Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Abortifacient Agents, Nonsteroidal Abortifacient Agents |