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Trial Title:
Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients with GI Malignancies
NCT ID:
NCT06648785
Condition:
GI Cancers
Conditions: Official terms:
Neoplasms
Oxaliplatin
Conditions: Keywords:
capecitabine
oxaliplatin
GI
chemotherapy
fluoropyrimidine
modified schedule
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
oxaliplatin
Description:
85 mg/m2 oxaliplatin
Arm group label:
Modified administration schedule of capecitabine with oxaliplatin
Intervention type:
Drug
Intervention name:
Fluoropyrimidine
Description:
oral fluoropyrimidine 1000mg/m2
Arm group label:
Modified administration schedule of capecitabine with oxaliplatin
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Vermont Medical Center
Address:
City:
Burlington
Zip:
05401
Country:
United States
Contact:
Last name:
Randall F. Holcombe, MD, MBA
Phone:
(802) 656-2021
Email:
randall.holcombe@med.uvm.edu
Contact backup:
Last name:
Randall F Holcombe, MD, MBA
Facility:
Name:
University of Vermont
Address:
City:
Burlington
Zip:
05401
Country:
United States
Contact:
Last name:
Randall Holcombe, MD, MBA
Phone:
(802) 656-2021
Email:
randall.holcombe@med.uvm.edu
Start date:
October 21, 2024
Completion date:
November 2026
Lead sponsor:
Agency:
University of Vermont Medical Center
Agency class:
Other
Source:
University of Vermont Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06648785
