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This study is a single arm, non-randomized feasibility study with tolerability and toxicity evaluation as primary endpoints which seeks to determine if a modified administration schedule of capecitabine with oxaliplatin will result in less toxicity than standard FOLFOX or CAPOX regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified administration schedule of capecitabine with oxaliplatin | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxaliplatin | Drug | 85 mg/m2 oxaliplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability | Number of toxicity-related treatment delays Number of dose reductions | 115 days |
| Toxicity | Severity of acute oxaliplatin reactions, graded 1-4 | 115 days |
| Neuropathy | Neuropathy will be graded 1-4 after 2 &4 months of severity | 2-4 months after therapy |
| Cytopenias | Frequency of cytopenia grade 3 or higher. | 115 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response | Response rate after 3-4 months, with exact time of restaging per investigator choice and investigator usual practice | 115 days |
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Inclusion Criteria:
Exclusion Criteria:
Patients not meeting standard hematologic parameters for chemotherapy administration as follows:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States | ||
| University of Vermont |
Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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Single arm pilot/feasibility design with tolerability and toxicity as primary endpoints and response as exploratory endpoint. Standard drug dosages utilized with no dose finding component to this study.
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| Fluoropyrimidine | Drug | oral fluoropyrimidine 1000mg/m2 |
|
| Burlington |
| Vermont |
| 05401 |
| United States |