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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Bristol-Myers Squibb Baylor College of Medicine |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00820170 |
The purpose of this study is to find the highest dose of dasatinib that can be safely given to a patient when the drug is given in combination with the known anticancer drug paclitaxel. Paclitaxel is an established anti-cancer drug, used in the treatment of many cancers, and it is an approved treatment for breast cancer. Dasatinib has been approved by the Food and Drug Administration for use as a single therapy in another kind of cancer, but its use in breast cancer patients, and in combination with paclitaxel is investigational.
In this study, we will test the safety of dasatinib when given at different dose levels in combination with paclitaxel. We want to find out what effects, good and/or bad, it has on the patient and on metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Dasatinib and Paclitaxel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I-II Study of Dasatinib in Combination With Weekly Paclitaxel for Patients With Metastatic Breast Carcinoma |
Estimated Enrollment: | 60 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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dasatinib and paclitaxel: Experimental
The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel. The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel. |
Drug: Dasatinib and Paclitaxel
A treatment cycle will consist of 28 days, according to the following schedule: Dasatinib PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle. The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel. |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of:
Prior therapies:
For the phase I portion: Any number of prior endocrine or biologic therapies is permitted . In addition, patients may be untreated in the metastatic setting or have received any number of prior cytotoxic regimens.
For the phase II portion: 0-2 prior therapies for metastatic disease are allowed.
Prior taxane therapy, either in the adjuvant or in the metastatic setting, either deliver weekly, q 2 weeks or q 3 weeks, will be permitted. Prior therapy with bevacizumab will be allowed. All previous chemotherapy, radiotherapy and intravenous bisphosphonates must have been discontinued at least 3 weeks prior to study entry, 3 weeks also for trastuzumab and bevacizumab. All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to NCI CTC (Version 3) Grade ≤1.
Concomitant Medications:
Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib) such as:
Women of childbearing potential (WOCBP) must have:
Exclusion Criteria:
Concurrent medical condition which may increase the risk of toxicity, including:
Cardiac Symptoms; any of the following should be considered for exclusion:
History of significant bleeding disorder unrelated to cancer, including:
Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
Contact: Monica Fornier, MD | 212 629-5240 | |
Contact: Clifford Hudis, MD | 212-639-5449 |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Monica Fornier, MD 212-629-5240 | |
Contact: Clifford Hudis, MD 212-639-5449 | |
Principal Investigator: Monica Fornier, MD | |
United States, Texas | |
Baylor College of Medicine | Not yet recruiting |
Houston, Texas, United States, 77005 | |
Contact: Jenny Chang, MD | |
Principal Investigator: Jenny Chang, MD |
Principal Investigator: | Monica Fornier, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Monica Fornier, MD ) |
Study ID Numbers: | 08-122 |
Study First Received: | January 8, 2009 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00820170 |
Health Authority: | United States: Institutional Review Board |
Breast Cancer DASATINIB TAXOL (PACLITAXEL) |
Skin Diseases Paclitaxel Dasatinib |
Breast Neoplasms Breast Diseases Carcinoma |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Enzyme Inhibitors Antimitotic Agents Protein Kinase Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |