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

NCT ID: NCT06648785

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2026-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified administration schedule of capecitabine with oxaliplatin

• 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.

Group Type: EXPERIMENTAL

oxaliplatin

Intervention Type: DRUG

85 mg/m2 oxaliplatin

Fluoropyrimidine

Intervention Type: DRUG

oral fluoropyrimidine 1000mg/m2

Interventions

oxaliplatin

85 mg/m2 oxaliplatin

Intervention Type: DRUG

Fluoropyrimidine

oral fluoropyrimidine 1000mg/m2

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Randall F Holcombe

Director-Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont Medical Center

Burlington, Vermont, United States

University of Vermont

Burlington, Vermont, United States

Countries

United States

Other Identifiers

STUDY00003100/UVMCC2404

Identifier Type: -

Identifier Source: org_study_id