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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 months for up to 5 years post treatment
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 2 months for up to 5 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months for up to 5 years post treatment
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
~2240
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have not coughed up more than half a teaspoon of blood daily in the past week.I have G6PD deficiency.I have no active cancer other than my lung cancer.I have been newly diagnosed with advanced lung cancer and haven't received any initial strong chemotherapy.I am 18 years old or older.You need to have at least 1500 white blood cells called neutrophils in a small amount of blood.Your hemoglobin level needs to be at least 8 grams per deciliter.I have taken EGFR or ALK inhibitors for my cancer but it has progressed.My brain metastasis is treated, stable, and I've been off steroids for 3+ days.I can care for myself and am up and about more than 50% of my waking hours.I am not taking flecainide, methadone, amphetamines, quinidine, or chlorpropamide.I can tolerate a vitamin C test dose.My cancer has EGFR mutations or ALK rearrangements, and I haven't tried specific inhibitors.I am currently taking insulin during my ascorbate treatments.My cancer has spread to the lining of my brain and spinal cord.I haven't had any cancer treatment for at least 6 months.You have HIV.You need to have at least 100,000 platelets per cubic millimeter of blood.Your creatinine levels are no more than 1.5 times the upper limit of normal.You have at least 50% of PD-L1 expression.I am on warfarin and cannot switch to another medication.Your bilirubin levels are not too high.Your AST levels are not more than three times the normal range for the testing lab.Your ALT levels are not more than three times the normal limit for the institution.
Research Study Groups:
This trial has the following groups:- Group 1: Ascorbate, paclitaxel, carboplatin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Paclitaxel been federally recognized in the United States?
"Paclitaxel is a medication that has been deemed safe by our team at Power. However, because this is only a Phase 2 trial, there is no data currently supporting its efficacy."
Answered by AI
For what types of cancer is Paclitaxel most indicated?
"A common use for Paclitaxel is treating malignant neoplasms. Additionally, it can also help alleviate symptoms of catarrh, vitamin deficiency, and act as a conditioning agent for stem cell transplantation therapy."
Answered by AI
What other scientific research has been conducted that uses Paclitaxel?
"As of now, 1282 clinical trials studying Paclitaxel are ongoing with 351 of those in Phase 3. Most investigations into Paclitaxel's effects are taking place in Shanghai, but there 67478 total locations around the world where researchers are looking into this medication."
Answered by AI
How many individuals are being asked to participate in this clinical trial?
"This cancer trial is no longer recruiting patients. The listing was first posted on April 1st, 2015 and updated for the last time on August 17th, 2022. However, there are still 1959 trials for carcinoma, non-small-cell lung searching for participants and 1282 trials involving Paclitaxel that are actively recruiting patients."
Answered by AI
Are investigators still enrolling patients in this research project?
"The clinical trial in question is not looking for patients at this time, however this may change in the future. This can be seen by looking at the date of the clinical trial's latest update on 8/17/2022. Additionally, there are 3241 other medical trials currently enrolling patients."
Answered by AI
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