Colorectal CancerPhase 2NCT03146962

High Dose Vitamin C Intravenous Infusion in Patients With Resectable or Metastatic Solid Tumor Malignancies

A Phase 2 study testing Vitamin C in people with Colorectal Cancer and Pancreatic Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer, Pancreatic Cancer, Lung Cancer
What is being tested?: Vitamin C
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 2 sitesUnited States
Study dates: 29 Mar 2017to 21 Apr 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female ≥ 18 years of age.
Patients with histologically proven early stage or locally advanced colorectal adenocarcinoma, lung cancer or pancreatic cancer, who are eligible for resection (cohort A).
Patients with inoperable, metastatic extended RAS (e.g. KRAS or NRAS) or BRAF mutant colorectal adenocarcinoma, lung cancer and pancreatic cancer, or other solid tumor, who have received at least 1 line of treatment for metastatic disease (cohort B).
Patients with metastatic cancer with an extended RAS (e.g. KRAS or NRAS) or BRAF mutation with liver metastases amenable to Y90 radioembolization (cohort C).
ECOG performance status 0-1.
Life expectancy of at least 6 months.
All women of child-bearing potential and all sexually active male patients must agree to use effective contraception.

Who cannot join

Patients with uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (NYHA class III and IV), uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements (Appendix B: New York Heart Association (NYHA) Classifications).
Patients with active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, unstable angina pectoris, or uncontrolled congestive heart failure (NYHA class III and IV) (Appendix B: New York Heart Association (NYHA) Classifications).
Patients who have received an investigational drug within 21 days of the first dose of study drug.
Patients who are pregnant or lactating.
Patients who are known to be positive for the human immunodeficiency virus (HIV). The effect of Vitamin C on HIV medications is unknown. Note: HIV testing is not required for eligibility, but if performed previously and was positive, the patient is ineligible for the study.
Patient who are receiving drugs which are known to interact with Vitamin C, potential risk and eligibility will be evaluated individually by the investigator. a. Most of the known interactions with vitamin C are from oral use and acidification of the stomach lining. There are few known interactions with high dose intravenous vitamin C. We recommend not using deferoxamine as there may be an association with ventricular dysfunction (unknown mechanism).

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Patients who have uncontrolled or severe hyponatremia, hypernatremia, SIADH, hypokalemia, hyperkalemia, hypomagnesemia, or hypermagnesemia
Patients who have uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months, such as hemoptysis, epistaxis, hematochezia, hematuria, or gastrointestinal bleeding.
Patients who require therapeutic doses of warfarin
Patients who have uncontrolled seizure disorder, ascites, iron overload, edema, or dehydration.
Patients who have glucose-6-phosphate dehydrogenase (G6PD) deficiency, hereditary spherocytosis, or other conditions predisposing patient to hemolysis.
Patients who have a known history of recurrent oxalate renal calculi or multiple oxalate.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Weill Cornell Medical College
New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase II Study of High Dose Vitamin C Intravenous Infusion in Patients With Resectable or Metastatic Solid Tumor Malignancies

This is a multicenter, single arm, 3-cohort, open-label trial of high dose Vitamin C intravenous infusion in subjects with solid tumor malignancies who are eligible for resection (cohort A) or with extended RAS (e.g.KRAS or NRAS) or BRAF mutation metastatic cancer who have received prior systemic treatment (cohort B). Cohort C will involve patients with colorectal cancer having an extended RAS or BRAF mutation who are amenable for localregional therapy of hepatic metastases with Yttrium-90 radioembolization.

Read the detailed description

This clinical trial is for men and women with resectable or metastatic solid tumor malignancies. The objective of the study is to investigate whether high dose vitamin C infusion leads to pathological tumor response in resectable colorectal, pancreatic, and lung cancer (cohort A) or objective tumor response in KRAS or BRAF mutant solid tumors (cohort B). For Cohort C, the primary objective is to determine that maximal tolerated dose of the combination of high dose vitamin C with Y90 radioembolization for patients solid tumor malignancies and liver metastases amenable to local-regional therapy

Patients in cohort A receive a high dose vitamin C infusion for 4 days per week for 2-4 consecutive weeks prior to surgery. Patients in cohort B receive high dose vitamin C infusion for 4 days per week for up to 6 months or disease progression. Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.

A tumor sample will be resected after completion of study drug (high dose vitamin C infusion) treatment to examine the effects of study drug (Cohort A only). In addition, organoids will be grown in vitro and continue to be treated with vitamin C added in culture medium to examine tumor response. The resected tumor in this study will

Key eligibility:

Men and women age 18 and older
Patients with histologically proven early stage or locally advanced colorectal adenocarcinoma, lung cancer or pancreatic cancer, who are eligible for resection, and have not received chemotherapy or radiotherapy (cohort A) Patients with inoperable, metastatic, KRAS or BRAF mutant colorectal adenocarcinoma, lung cancer and pancreatic cancer, who have received at least 1 line of treatment for metastatic disease (cohort B)
Patients with metastatic cancer with an extended RAS (e.g. KRAS or NRAS) or BRAF mutation with liver metastases amenable to Y90 radioembolization (cohort C).

Conditions: Colorectal Cancer, Pancreatic Cancer, Lung Cancer
Being tested: Vitamin C
Medical subject headings: Colorectal Neoplasms, Pancreatic Neoplasms, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin CDrug
Also called Ascorbic Acid
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.

Study groups in NCT03146962
Study group	Role	What they receive
Cohort A: Vitamin C + Surgery	Experimental	Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Receives: Drug: Vitamin C
Cohort B: Vitamin C Only	Experimental	Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for up to 6 months. Receives: Drug: Vitamin C
Cohort C: Vitamin C + Y-90 Dose Level 1	Experimental	Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. Receives: Drug: Vitamin C
Cohort C: Vitamin C + Y-90 Dose Level 2	Experimental	Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. Receives: Drug: Vitamin C
Cohort C: Vitamin C + Y-90 Dose Level 3	Experimental	Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Receives: Drug: Vitamin C
Cohort C: Vitamin C + Y-90 Dose Level 4	Experimental	Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Receives: Drug: Vitamin C
Cohort C: Vitamin C + Y-90 Dose Level 5	Experimental	A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy. Receives: Drug: Vitamin C
Cohort C: Vitamin C + Y-90 Dose Level 6	Experimental	A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy. Receives: Drug: Vitamin C
Cohort C: Vitamin C + Y-90 Dose Level 7	Experimental	A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy. Receives: Drug: Vitamin C
Cohort C: Vitamin C + Y-90 Dose Level 8	Experimental	A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy. Receives: Drug: Vitamin C

What is being measured

The primary outcome is the main question the study is designed to answer.

Pathologic Response Based on Tumor Regression Grading in Cohort A Patients
Number of patients with partial or complete pathological response in surgically resected tumor tissue: Pathological response rate is the number of patients with partial or complete pathological response in surgically resected tumor tissue. Pathologic response was assessed by tumor regression grade. This is a pathologic assessment of the amount of residual cancer cells in the specimen and the degree of fibrosis in the sample specimen. A completer response is 0% residual cancer cells. A partial response is 10-50% residual cancer cells, and no response is >50% residual cancer cells within the tumor specimen.
Measured: cohort A - 8 weeks
3-month Disease Control Rate (DCR) Will be Evaluated Using RECIST v 1.1 in Cohort B Patients.
Percentage of patients with complete response, partial response, or stable disease as a result of their therapy at 3 months
Measured: Cohort B - 3 months
Maximal Tolerated Dose of High Dose Vitamin C in Combination With Y90 Radioembolization
Maximal tolerated dose will be evaluated by assessment of dose limiting toxicities for multiple dose levels. Dose limiting toxicity will be defined as any grade 3-4 adverse event possibly, probably, or definitely attributed to vitamin C therapy in the 21 days of protocol therapy. In any group of 3 patients, if one patient experiences dose limiting toxicity, the group will be expanded by 3 additional patients (eg. 6 for that group). If, at any dose level, 2 or more patients experience a dose limiting toxicity, the maximal tolerated dose will be reached, and further dose escalation will not be pursued. The dose level may then be expanded up to 10 additional patients to confirm the safety and toxicity at that dose level.
Measured: Cohort C - 16 weeks

Secondary outcomes (5)

Progression-free Survival (PFS)
PFS is defined as the time from registration to cancer progression or death due to any cause for up to 6 months. Cancer progression is defined using the Response Evaluation Criteria in Solid Tumors v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.
Measured: cohort B - up to 6 months
Objective Response Rate (ORR)
Number of patients with a partial response or complete response based on RECIST 1.1 Criteria.
Measured: cohort B - up to 6 months cohort C - 16 weeks
Time to Maximum Concentration and Half-life of Vitamin C (t1/2) in Hours in Cohort B
The serum concentration of vitamin C was serially measured following vitamin C infusion at 1.25 g/kg at various timepoints up to 24 hours post infusion to determine the Tmax and t(1/2) in hours
Measured: Up to 24 hours post-infusion
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
The number of participants per cohort who experienced a Grade 3 or 4 adverse event (as defined by CTCAE v4.03) that was deemed possibly, probably, or definitely related to Vitamin C.
Measured: Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration.
Maximum Concentration of Vitamin C in Hours in Cohort B
The serum concentration of vitamin C was serially measured following vitamin C infusion at 1.25 g/kg at various timepoints up to 24 hours post infusion to determine the maximum concentration (Cmax) in mM.
Measured: Up to 24 hours post-infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 201721 Apr 2023

First posted10 May 2017
Study start29 Mar 2017
Primary completion21 Apr 2023
Study completion21 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03146962
Sponsor's protocol ID: 1610017688
Status last verified: Apr 2024
First submitted: 27 Apr 2017
Last updated: 2 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of High Dose Vitamin C Intravenous Infusion in Patients With Resectable or Metastatic Solid Tumor Malignancies
ClinicalTrials.gov ID: NCT03146962
Acronym / sponsor ID: 1610017688
Conditions: Colorectal Cancer, Pancreatic Cancer, Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: Stand Up To Cancer
Study start: 29 Mar 2017 (actual)
Primary completion: 21 Apr 2023 (actual)
Study completion: 21 Apr 2023 (actual)
First posted: 10 May 2017 (actual)
Results: Posted 2 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Key eligibility:

Men and women age 18 and older
Patients with histologically proven early stage or locally advanced colorectal adenocarcinoma, lung cancer or pancreatic cancer, who are eligible for resection, and have not received chemotherapy or radiotherapy (cohort A) Patients with inoperable, metastatic, KRAS or BRAF mutant colorectal adenocarcinoma, lung cancer and pancreatic cancer, who have received at least 1 line of treatment for metastatic disease (cohort B)
Patients with metastatic cancer with an extended RAS (e.g. KRAS or NRAS) or BRAF mutation with liver metastases amenable to Y90 radioembolization (cohort C).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
Cohort A: Vitamin C + Surgery	Experimental	Drug: Vitamin CVitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks.
Cohort B: Vitamin C Only	Experimental	Drug: Vitamin CVitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for up to 6 months.
Cohort C: Vitamin C + Y-90 Dose Level 1	Experimental	Drug: Vitamin CVitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2	Experimental	Drug: Vitamin CVitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3	Experimental	Drug: Vitamin CVitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4	Experimental	Drug: Vitamin CVitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5	Experimental	Drug: Vitamin CA single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6	Experimental	Drug: Vitamin CA single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7	Experimental	Drug: Vitamin CA single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8	Experimental	Drug: Vitamin CA single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female ≥ 18 years of age.
Patients with histologically proven early stage or locally advanced colorectal adenocarcinoma, lung cancer or pancreatic cancer, who are eligible for resection (cohort A).
Patients with inoperable, metastatic extended RAS (e.g. KRAS or NRAS) or BRAF mutant colorectal adenocarcinoma, lung cancer and pancreatic cancer, or other solid tumor, who have received at least 1 line of treatment for metastatic disease (cohort B).
Patients with metastatic cancer with an extended RAS (e.g. KRAS or NRAS) or BRAF mutation with liver metastases amenable to Y90 radioembolization (cohort C).
ECOG performance status 0-1.

Key exclusion criteria (12 listed)

Patients with uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (NYHA class III and IV), uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements (Appendix B: New York Heart Association (NYHA) Classifications).
Patients with active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, unstable angina pectoris, or uncontrolled congestive heart failure (NYHA class III and IV) (Appendix B: New York Heart Association (NYHA) Classifications).
Patients who have received an investigational drug within 21 days of the first dose of study drug.
Patients who are pregnant or lactating.
Patients who are known to be positive for the human immunodeficiency virus (HIV). The effect of Vitamin C on HIV medications is unknown. Note: HIV testing is not required for eligibility, but if performed previously and was positive, the patient is ineligible for the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin CAlso: Ascorbic AcidVitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.	Drug	Cohort A: Vitamin C + Surgery, Cohort B: Vitamin C Only, Cohort C: Vitamin C + Y-90 Dose Level 1, Cohort C: Vitamin C + Y-90 Dose Level 2, Cohort C: Vitamin C + Y-90 Dose Level 3, Cohort C: Vitamin C + Y-90 Dose Level 4, Cohort C: Vitamin C + Y-90 Dose Level 5, Cohort C: Vitamin C + Y-90 Dose Level 6, Cohort C: Vitamin C + Y-90 Dose Level 7, Cohort C: Vitamin C + Y-90 Dose Level 8

Primary outcome

Pathologic Response Based on Tumor Regression Grading in Cohort A Patients
Time frame: cohort A - 8 weeks
Number of patients with partial or complete pathological response in surgically resected tumor tissue: Pathological response rate is the number of patients with partial or complete pathological response in surgically resected tumor tissue. Pathologic response was assessed by tumor regression grade. This is a pathologic assessment of the amount of residual cancer cells in the specimen and the degree of fibrosis in the sample specimen. A completer response is 0% residual cancer cells. A partial response is 10-50% residual cancer cells, and no response is >50% residual cancer cells within the tumor specimen.
3-month Disease Control Rate (DCR) Will be Evaluated Using RECIST v 1.1 in Cohort B Patients.
Time frame: Cohort B - 3 months
Percentage of patients with complete response, partial response, or stable disease as a result of their therapy at 3 months
Maximal Tolerated Dose of High Dose Vitamin C in Combination With Y90 Radioembolization
Time frame: Cohort C - 16 weeks
Maximal tolerated dose will be evaluated by assessment of dose limiting toxicities for multiple dose levels. Dose limiting toxicity will be defined as any grade 3-4 adverse event possibly, probably, or definitely attributed to vitamin C therapy in the 21 days of protocol therapy. In any group of 3 patients, if one patient experiences dose limiting toxicity, the group will be expanded by 3 additional patients (eg. 6 for that group). If, at any dose level, 2 or more patients experience a dose limiting toxicity, the maximal tolerated dose will be reached, and further dose escalation will not be pursued. The dose level may then be expanded up to 10 additional patients to confirm the safety and toxicity at that dose level.

5 secondary outcomes

Progression-free Survival (PFS)
Time frame: cohort B - up to 6 months
Objective Response Rate (ORR)
Time frame: cohort B - up to 6 months cohort C - 16 weeks
Time to Maximum Concentration and Half-life of Vitamin C (t1/2) in Hours in Cohort B
Time frame: Up to 24 hours post-infusion
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Time frame: Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration.
Maximum Concentration of Vitamin C in Hours in Cohort B
Time frame: Up to 24 hours post-infusion

Results and safety

Results posted to the registry on 2 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A: Vitamin C + Surgery	7	5
Cohort B: Vitamin C Only	21	15
Cohort C: Vitamin C + Y-90 Dose Level 1	3	3
Cohort C: Vitamin C + Y-90 Dose Level 2	3	3
Cohort C: Vitamin C + Y-90 Dose Level 3	4	3
Cohort C: Vitamin C + Y-90 Dose Level 4	3	3
Cohort C: Vitamin C + Y-90 Dose Level 5	3	3
Cohort C: Vitamin C + Y-90 Dose Level 6	7	6
Cohort C: Vitamin C + Y-90 Dose Level 7	3	3
Cohort C: Vitamin C + Y-90 Dose Level 8	7	6

Primary outcome: Pathologic Response Based on Tumor Regression Grading in Cohort A Patients

Time frame: cohort A - 8 weeks. Count of participants. Unit: Participants

Measure	Cohort A: Vitamin C + Surgery n = 6
Value	1

Population analysed: Only the 6 patients who had surgery from Cohort A, and thus had evaluable tissue, were analyzed for this measure. Participants in Cohort B and C did not undergo surgery, and were thus not evaluable.

Primary outcome: 3-month Disease Control Rate (DCR) Will be Evaluated Using RECIST v 1.1 in Cohort B Patients.

Time frame: Cohort B - 3 months. Count of participants. Unit: Participants

Measure	Cohort B: Vitamin C Only n = 16
Value	1

Population analysed: DCR was not collected for Cohort A or Cohort C. 5 participants from Cohort B were missing scans and were therefor unevaluable.

Primary outcome: Maximal Tolerated Dose of High Dose Vitamin C in Combination With Y90 Radioembolization

Time frame: Cohort C - 16 weeks. Number. Unit: g/kg

Measure	Cohort C: Vitamin C + Y-90 (All Dose Levels) n = 30
Vitamin C Weekly Infusion Dose	1.25
Vitamin C Infusion Dose the Day of Y-90 Radioembolization	1.25

Population analysed: Only patients that received a dose of Vitamin C in Cohort C were considered evaluable. In Cohort C, 30 out of 32 participants who received vitamin C were evaluated across dose levels. Cohort A and B were not dose escalations, and therefore were not evaluated for maximum tolerated dose.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A: Vitamin C + Surgery	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
Cohort B Vitamin C Only	4 of 19 (21.1%)	18 of 19 (94.7%)	1 of 21
Cohort C: Vitamin C + Y-90 Dose Level 1	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort C: Vitamin C + Y-90 Dose Level 2	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort C: Vitamin C + Y-90 Dose Level 3	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Cohort C: Vitamin C + Y-90 Dose Level 4	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort C: Vitamin C + Y-90 Dose Level 5	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort C: Vitamin C + Y-90 Dose Level 6	4 of 7 (57.1%)	7 of 7 (100%)	2 of 7
Cohort C: Vitamin C + Y-90 Dose Level 7	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Cohort C: Vitamin C + Y-90 Dose Level 8	2 of 6 (33.3%)	5 of 6 (83.3%)	1 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Colorectal Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Manish Shah, MD principal investigator

Weill Medical College of Cornell University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin C in people with Colorectal Cancer and Pancreatic Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Response Based on Tumor Regression Grading in Cohort A Patients (time frame: cohort A - 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03146962.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.