Vitamin C Intravenously With Chemotherapy in Advanced Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-12-30

Brief Summary

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Preclinical study has shown that human colorectal cancer cells harboring KRAS or BRAF mutations are selectively killed by high levels of ascorbic acid (AA). High dose of AA aslo impairs tumor growth in Apc/KRASG12D mutant mice. Previous phase Ⅰ studies have found that high dose iv AA is well tolerated in cancer patients.This protocol is a phase Ⅲ study of AA infusions combined with treatment with FOLFOX +/- bevacizumab versus treatment with FOLFOX +/- bevacizumab alone as first-line therapy in patients with recurrent or advanced colorectal cancer.

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Detailed Description

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Linus Pauling and Dr Ewan Cameron have published two retrospective studies about using high dose vitamin C to treat cancer patients forty years ago. Their studies have shown that high dose vitamin C usage could significantly prolong overall survival of patients with advanced cancer. Recently, preclinical study has shown that human colorectal cancer cells harboring KRAS or BRAF mutations are selectively killed by high levels of ascorbic acid (AA). High dose of AA impairs tumor growth in Apc/KRASG12D mutant mice. Previous phaseⅠ clinical trials have found that high dose (1.5g/kg or 90g/m2) iv AA is well tolerated in cancer patients. This protocol is a phase Ⅲ, study of ascorbic acid (AA) infusions combined with treatment with FOLFOX +/- bevacizumab versus treatment with FOLFOX +/- bevacizumab alone as first-line therapy in patients with recurrent or advanced colorectal cancer.

Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ascorbic Acid with chemotherapy group

Ascorbic Acid with mFOLFOX6 with or without bevacizumab Ascorbic Acid (1.5g/kg/day, D1-3) every 2 weeks

mFOLFOX6:

* Oxaliplatin 85 mg/m² d1 concurrent with
* Leucovorin 400 mg/m², 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

Group Type EXPERIMENTAL

ascorbic acid

Intervention Type DRUG

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

Chemotherapy

Intervention Type DRUG

* mFOLFOX6
* Oxaliplatin 85 mg/m² d1 concurrent with
* Leucovorin 400 mg/m², 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

Chemotherapy group

mFOLFOX6:

* Oxaliplatin 85 mg/m² d1 concurrent with
* Leucovorin 400 mg/m², 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

Group Type ACTIVE_COMPARATOR

Chemotherapy

Intervention Type DRUG

* mFOLFOX6
* Oxaliplatin 85 mg/m² d1 concurrent with
* Leucovorin 400 mg/m², 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

Interventions

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ascorbic acid

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

Intervention Type DRUG

Chemotherapy

* mFOLFOX6
* Oxaliplatin 85 mg/m² d1 concurrent with
* Leucovorin 400 mg/m², 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

Intervention Type DRUG

Other Intervention Names

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Vitamin C mFOLFOX6+/- bevacizumab

Eligibility Criteria

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Inclusion Criteria

Age≥18 years, ≤75 years; Histologically proven metastatic adenocarcinoma of colorectal cancer (stage Ⅳ disease), unresectable metastatic disease; measurable disease; G6PD status \> lower limit of normal; 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; Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the study; 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 who are on strong inducers of CYP3A4 which include but are not limited to: Aminoglutethimide, Bexarotene, Bosentan, Carbamazepine, Dexamethasone, Efavirenz, Fosphenytoin, Griseofulvin, Modafinil, Nafcillin, Nevirapine, Oxcarbazepine, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Rifapentine, St. John's wort; Medical, social or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent; Organ allograft requiring immunosuppressive therapy; Patients with HIV infection

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No