XAD - Xelox (Capecitabine + Oxaliplatin) + Bevacizumab + Dasatinib
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™ ).
Metastatic Colorectal Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- To determine the maximum tolerated dose(MTD)/recommended phase II dose (RPTD) of capecitabine/oxaliplatin/bevacizumab/dasatinib for patients with advanced solid tumors. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
- To further describe dose-limiting and non-dose-limiting toxicities associated with this regimen. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- To describe clinical activity (partial response (PR), complete response (CR) or stable disease (SD)>6 months, time to progression, and overall survival) associated with this regimen for patients with previously untreated metastatic and/or re [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To explore any correlation between blood, urine, and paraffin biomarkers and clinical outcomes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||October 2014|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Dasatinib 50mg
dasatinib at 50 mg PO BID)
Other Name: SprycelDrug: bevacizumab
7.5 mg/kg IV day 1
Other Name: AvastinDrug: Oxaliplatin
130 mg/m2 IV day 1
Other Name: EloxatinDrug: Capecitabine
850 mg/m2 PO BID on days 1-14
Other Name: Xeloda
|United States, Colorado|
|Rocky Mountain Cancer Center|
|Denver, Colorado, United States, 80218|
|United States, North Carolina|
|Duke Univeristy Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Herbert I Hurwitz, MD||Duke University|