IV Ascorbic Acid in Peritoneal Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Vitamin C Intravenously With Chemotherapy in Peritoneal Metastatic Colorectal Cancer With High Expresison Level of GLUT3

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04516681
• Other study ID #: Vitamin C-GLUT3-2020
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2020
• Source: Fudan University
• Contact: Guoxiang Cai
• Phone: 13122618708
• Email: gxcaifuscc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous preclinical study has shown that high levels of ascorbic acid (AA) possesses the ability to kill human colorectal cancer cells and high expression of GLUT3 will augment the efficacy of AA. To date, no previous studies have investigated the therapeutic role of AA in peritoneal metastatic colorectal cancer with high expression of GLUT3. This protocol is a randomized controlled study of AA infusions combined with FOLFOXIRI +/- bevacizumab versus treatment with FOLFOXIRI +/- bevacizumab alone in peritoneal metastatic colorectal cancer patients with high expression of GLUT3.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age=18 years, =75 years; Histologically proven peritoneal metastatic adenocarcinoma of colorectal cancer, unresectable metastatic disease; IHC confirmed strong positive GLUT3; measurable disease; Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1; Life expectancy of at least 12 weeks; ANC =1,500/mm3; Hemoglobin > 8g/dL; platelet = 100,000/mm3; Laboratory at baseline evaluation for inclusion in the study: creatinine =1.5X upper limit [if the creatinine is elevated, but =1.5X the ULN, a 24 hour creatinine clearance will be obtained, Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)]; Transaminase (AST/ALT) =2.5X upper limit of normal and bilirubin levels =1.5X upper limit of normal without liver metastasis; Transaminase (AST/ALT) =5X upper limit of normal and bilirubin levels =1.5X upper limit of normal with liver metastasis; Written informed consent

Exclusion Criteria:

• Prior treatment for metastatic disease (adjuvant therapy with fluoropyrimidines +/-oxaliplatin based regimens allowed if stopped 12 months prior to registration on study); Surgery (excluding diagnostic biopsy) or irradiation within 3 weeks prior to study entry; Administration of any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment; Concurrent chronic systemic immune therapy, chemotherapy, radiation therapy (palliative radiation therapy allowed) or hormone therapy not indicated in the study protocol; Brain metastasis (known or suspected); Pregnant or lactating women; Other uncontrolled concomitant illness, including serious uncontrolled intercurrent infection; Known allergy or any other adverse reaction to any of the drugs or to any related compound; Previous (within 5 years) or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and basal cell carcinoma of the skin; Patients with low or moderate expression of GLUT3.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• GLUT3
• Vitamin C

Intervention

Drug:
• Ascorbic acid
1.5g/kg/day, D1-3, every 2 weeks
• FOLFOXIRI Protocol
CPT-11 165 mg/m² d1 concurrent with Leucovorin 400 mg/m², followed by Oxaliplatin 85 mg/m² d1 followed by Bolus 5FU 400 mg/m² , followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks with or without bevacizumab 5mg/kg, every 2 weeks

Locations

Country	Name	City	State
China	Fudan university shanghai cancer center	Shanhai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	To utilize CT or MRI scans to assess overall tumor response rate (complete and partial response) in subjects with peritoneal metastatic colorectal cancer treated with the combination of ascorbic acid and FOLFOXIRI +/- bevacizumab versus treatment with FOLFOXIRI +/- bevacizumab alone	up to 5 years
Secondary	Progression Free Survival	Time-to-event outcome measure (initial disease progression) measured in days from cycle 1 day 1 to day of first progression as defined by RECIST1.1 criteria from NCI	up to 5 years
Secondary	Overall Survival	Time to event outcome measure (death), measured in days from cycle 1 day 1	up to 5 years