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IV Ascorbic Acid in Peritoneal Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer, Vitamin C, GLUT3

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Ascorbic acid

FOLFOXIRI Protocol

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fudan university shanghai cancer centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined Ascorbic Acid with chemotherapy group

Chemotherapy alone group

Arm Description

Ascorbic Acid with FOLFOXIRI with or without bevacizumab Ascorbic Acid (1.5g/kg/day, D1-3) every 2 weeks

standard FOLFOXIRI treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Overall Survival

Time to event outcome measure (death), measured in days from cycle 1 day 1

Full Information

NCT ID

NCT04516681

First Posted

August 12, 2020

Last Updated

August 14, 2020

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04516681

Brief Title

IV Ascorbic Acid in Peritoneal Metastatic Colorectal Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2020 (Anticipated)

Primary Completion Date

September 1, 2022 (Anticipated)

Study Completion Date

September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Vitamin C, GLUT3

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combined Ascorbic Acid with chemotherapy group

Arm Type

Experimental

Arm Description

Ascorbic Acid with FOLFOXIRI with or without bevacizumab Ascorbic Acid (1.5g/kg/day, D1-3) every 2 weeks

Arm Title

Chemotherapy alone group

Arm Type

Active Comparator

Arm Description

standard FOLFOXIRI treatment

Intervention Type

Drug

Intervention Name(s)

Ascorbic acid

Other Intervention Name(s)

Vitamin C

Intervention Description

1.5g/kg/day, D1-3, every 2 weeks

Intervention Type

Drug

Intervention Name(s)

FOLFOXIRI Protocol

Other Intervention Name(s)

FOLFOXIRI+/- bevacizumab

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective Response Rate

Description

Time Frame

up to 5 years

Secondary Outcome Measure Information:

Title

Progression Free Survival

Description

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

Time Frame

up to 5 years

Title

Overall Survival

Description

Time to event outcome measure (death), measured in days from cycle 1 day 1

Time Frame

up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guoxiang Cai

Phone

13122618708

Ext

13122618708

gxcaifuscc@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Renjie Wang

Phone

18817519285

Ext

+86

wangbladejay@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guoxiang Cai, Doctor

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan university shanghai cancer center

City

Shanhai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

WEIXING DAI

Phone

13122618708

Ext

13122618708

wxdai17@fudan.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

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IV Ascorbic Acid in Peritoneal Metastatic Colorectal Cancer

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