Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients With GI Malignancies

NCT06648785 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00003100/UVMCC2404
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

GI Cancers

Keywords

capecitabine; oxaliplatin; GI; chemotherapy; fluoropyrimidine; modified schedule

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Tumor response

  115 days

Study Arms (1)

Modified administration schedule of capecitabine with oxaliplatin

EXPERIMENTAL

* Oxaliplatin (85mg/m2), will be administered IV every 2 weeks * Capecitabine (1000mg/m2) will be given twice daily, administered orally (PO) for 7 days, followed by 7 days with no capecitabine Cycles will repeat every 14 days.

Drug: oxaliplatin; Drug: Fluoropyrimidine

Interventions

oxaliplatin DRUG

85 mg/m2 oxaliplatin

Modified administration schedule of capecitabine with oxaliplatin

Fluoropyrimidine DRUG

oral fluoropyrimidine 1000mg/m2

Modified administration schedule of capecitabine with oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (2)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Interventions

Oxaliplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director-Faculty

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 18, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)