Solid Tumor Clinical Trial
Official title:
A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and Dasatinib for Patients With Advanced Solid Tumors With Expanded Cohort of Patients With Previously Untreated Metastatic Colorectal Cancer.
The primary purpose of this study is to find the highest tolerated dose of the study drugs:
capecitabine, oxaliplatin, bevacizumab, and dasatinib given in combination to subjects with
advanced solid tumors. This will occur in the first part of the study (Phase I). Once this
dose has been determined, it will be given to subjects with advanced metastatic colorectal
cancer in the second part of the study (Phase II).
By giving these drugs in combination, researchers hope to evaluate the side effects of the
study drugs in both groups, and to determine if this combination could possibly decrease or
stabilize the cancer being treated.
Subjects will be enrolled at Duke University Medical Center (DUMC) and Rocky Mountain Cancer
Center.
After satisfying eligibility and screening criteria, patients will be treated on 21 day
cycles.
ABOUT THE STUDY DRUGS
- Capecitabine (Xeloda™) is an oral (taken by mouth) chemotherapy drug in tablet form
made by Roche Laboratories Inc. Capecitabine has been approved for use by the Food and
Drug Administration (FDA) for first line treatment (treatment that should be used for
cancer that has not been treated yet) of metastatic colorectal cancer and also for
metastatic breast cancer.
- Oxaliplatin (Eloxatin™) is an intravenous (given by injection into a vein) chemotherapy
drug made by Sanofi-Synthélabo. This drug is also approved by the FDA for use in
metastatic colorectal cancer.
- Bevacizumab (Avastin™) is a type of intravenous cancer treatment called anti-angiogenic
therapy (a type of therapy to treat cancer that interferes with blood flow to the
tumor, thereby stopping tumor growth, and possibly leading to tumor shrinkage) made by
Genentech Inc. Bevacizumab is approved by the FDA for first line treatment of
metastatic colorectal cancer in combination with other chemotherapy.
- Dasatinib (Sprycel™) is an oral drug made by Bristol Myers Squib, Inc (BMS). Dasatinib
is approved by the FDA for the treatment of chronic myeloid leukemia (CML), acute
lymphoblastic leukemia or for patients that are resistant to a medicine called imatinib
mesylate (Gleevec™ ).
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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