GI Cancers
Conditions
Keywords
capecitabine, oxaliplatin, GI, chemotherapy, fluoropyrimidine, modified schedule
Brief summary
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.
Interventions
DRUGoxaliplatin
85 mg/m2 oxaliplatin
DRUGFluoropyrimidine
oral fluoropyrimidine 1000mg/m2
Sponsors
University of Vermont Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with GI malignancy * Provider plans non-curative intent treatment with either CAPOX or FOLFOX (mFOLFOX6) at standard dosages for \>3 months NOTE: Patient is not required to have radiologically measurable disease. NOTE: Planned administration of other anti-cancer medications (eg bevacizumab, epidermal growth factor receptor antibodies, immunotherapy, tyrosine kinase inhibitors) is allowed.
Exclusion criteria
* Patients not meeting standard hematologic parameters for chemotherapy administration as follows: * Absolute neutrophil count (ANC) ≥ 1500 * Platelet count ≥ 100,000 Patients not meeting standard liver function parameters for chemotherapy administration as follows: * AST ≤ 5x ULN * ALT ≤ 5X ULN * Total Bilirubin ≤ 1.5X ULN Patients not meeting standard renal function parameters for chemotherapy administration as follows: * Serum Creatinine ≤ 1.2 or creatinine clearance ≥ 30 ml/min NOTE: Planned administration of another cytotoxic chemotherapy (eg irinotecan) is an exclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability | 115 days | Number of toxicity-related treatment delays Number of dose reductions |
| Toxicity | 115 days | Severity of acute oxaliplatin reactions, graded 1-4 |
| Neuropathy | 2-4 months after therapy | Neuropathy will be graded 1-4 after 2 \&4 months of severity |
| Cytopenias | 115 days | Frequency of cytopenia grade 3 or higher. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | 115 days | Response rate after 3-4 months, with exact time of restaging per investigator choice and investigator usual practice |
Countries
United States
Outcome results
None listed