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Platinum-based Chemotherapy

High-Dose Vitamin C + Chemotherapy for Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by Joseph J. Cullen, MD, FACS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed stage IIIB or IV non-small cell lung cancer with no prior first-line cytotoxic therapy
At least 18 years of age
Must not have
Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Active hemoptysis within 1 week of screening (more than 1/2 teaspoon of blood per day)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 months for up to 5 years post treatment
Awards & highlights

Summary

This trial is testing whether adding high-dose vitamin C to the standard treatment for non-small cell lung cancer will improve outcomes.

Who is the study for?
Adults with newly diagnosed stage IIIB or IV non-small cell lung cancer who haven't had first-line cytotoxic therapy. They must have certain blood counts within normal ranges, be able to tolerate a vitamin C test dose, and not be pregnant or breastfeeding. Those with treated and stable brain metastasis can join; however, individuals with specific health conditions or on certain medications are excluded.Check my eligibility
What is being tested?
The trial is testing the addition of high-dose ascorbate (vitamin C) to standard chemotherapy treatments Paclitaxel and Carboplatin for non-small cell lung cancer. All participants will receive this combination to see if it improves treatment outcomes.See study design
What are the potential side effects?
High-dose vitamin C may cause side effects such as digestive discomfort, headache, fatigue, or skin reactions. Chemotherapy drugs like Paclitaxel and Carboplatin can lead to hair loss, nerve damage, nausea, low blood counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been newly diagnosed with advanced lung cancer and haven't received any initial strong chemotherapy.
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I am 18 years old or older.
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I can tolerate a vitamin C test dose.
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I can care for myself and am up and about more than 50% of my waking hours.
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I haven't had any cancer treatment for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I have not coughed up more than half a teaspoon of blood daily in the past week.
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I have G6PD deficiency.
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I have no active cancer other than my lung cancer.
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My cancer has EGFR mutations or ALK rearrangements, and I haven't tried specific inhibitors.
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I am currently taking insulin during my ascorbate treatments.
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My cancer has spread to the lining of my brain and spinal cord.
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I am not taking flecainide, methadone, amphetamines, quinidine, or chlorpropamide.
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I am on warfarin and cannot switch to another medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months for up to 5 years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months for up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tumor Response
Secondary outcome measures
Adverse Event Frequency
Overall Survival (OS)
Progression Free Survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ascorbate, paclitaxel, carboplatinExperimental Treatment3 Interventions
Paclitaxel, administered once per cycle (3 weeks) Carboplatin, administered once per cycle (3 weeks) Pharmacological ascorbate (ascorbic acid) infusions, 2 times per week for 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Ascorbic Acid
2017
Completed Phase 4
~2280

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, immunotherapy, and high-dose ascorbate. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapies, such as EGFR inhibitors, specifically target molecular abnormalities in cancer cells, minimizing damage to normal cells. Immunotherapy, including PD-1/PD-L1 inhibitors, boosts the body's immune system to recognize and destroy cancer cells. High-dose ascorbate (vitamin C) acts as a pro-oxidant, generating hydrogen peroxide to induce cytotoxicity selectively in cancer cells. This is significant for NSCLC patients as it offers a potential treatment that can enhance the efficacy of conventional therapies while potentially reducing their side effects.
Why Vitamin C Could Be an Excellent Complementary Remedy to Conventional Therapies for Breast Cancer.Mechanisms of anti-cancer effects of ascorbate: Cytotoxic activity and epigenetic modulation.Inhibition of epigallocatechin gallate-induced apoptosis by CoCl2 in human oral tumor cell lines.

Find a Location

Who is running the clinical trial?

Holden Comprehensive Cancer CenterOTHER
26 Previous Clinical Trials
722 Total Patients Enrolled
McGuff Pharmaceuticals, Inc.Industry Sponsor
3 Previous Clinical Trials
88 Total Patients Enrolled
Joseph J. Cullen, MD, FACSLead Sponsor
3 Previous Clinical Trials
119 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02420314 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Ascorbate, paclitaxel, carboplatin
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02420314 — Phase 2
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02420314 — Phase 2
~5 spots leftby Jul 2025