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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib 50mg | Experimental | Cohort 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dasatinib | Drug | dasatinib at 50 mg PO BID) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose(MTD)/recommended phase II dose (RPTD) of capecitabine/oxaliplatin/bevacizumab/dasatinib for patients with advanced solid tumors. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| To further describe dose-limiting and non-dose-limiting toxicities associated with this regimen. | 12 months | |
| 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 |
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Inclusion Criteria:
Criteria Specific for Dose Escalation (Phase I)
Criteria Specific for Expanded Cohort Portion of Trial Only
Inclusion Criteria for All Participants
Exclusion Criteria for ALL Subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert I Hurwitz, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States | ||
| Duke Univeristy Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24173967 | Derived | Strickler JH, McCall S, Nixon AB, Brady JC, Pang H, Rushing C, Cohn A, Starodub A, Arrowood C, Haley S, Meadows KL, Morse MA, Uronis HE, Blobe GC, Hsu SD, Zafar SY, Hurwitz HI. Phase I study of dasatinib in combination with capecitabine, oxaliplatin and bevacizumab followed by an expanded cohort in previously untreated metastatic colorectal cancer. Invest New Drugs. 2014 Apr;32(2):330-9. doi: 10.1007/s10637-013-0042-9. Epub 2013 Nov 1. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| D000068258 | Bevacizumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| bevacizumab | Drug | 7.5 mg/kg IV day 1 |
|
|
| Oxaliplatin | Drug | 130 mg/m2 IV day 1 |
|
|
| Capecitabine | Drug | 850 mg/m2 PO BID on days 1-14 |
|
|
| 2 years |
| To explore any correlation between blood, urine, and paraffin biomarkers and clinical outcomes | 3 years |
| Durham |
| North Carolina |
| 27710 |
| United States |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |