Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Ascorbic Acid

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Trace Elements

Antioxidants

Protective Agents

Vitamin C

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

* Administered intravenously (IV)
* Prescribed at 200 mg/m2 (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response

* Administered intravenously (IV)
* Prescribed at AUC = 6 using the Cockcroft-Gault formula (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response

* Administered intravenously (IV)
* 75g per infusion
* Two infusions per week
* 1 cycle is 3 weeks
* given up to 4 cycles
* may be given while chemotherapy if delayed due to low counts

Joseph J. Cullen, MD, FACS

This clinical trial evaluates adding high-dose ascorbate (vitamin C) to standard of care treatment of non-small cell lung cancer (NSCLC) in adults. All subjects will receive high-dose ascorbate in addition to the standard treatment.

Standard treatment for non-small cell lung cancer (NSCLC) involves a combined therapy of paclitaxel and carboplatin. These drugs are administered once every 21 days. This study adds high dose ascorbic acid (75g per infusion) twice per week for up to 4 cycles of therapy.

Participants will:

* receive high doses of intravenous (IV) ascorbate two times a week during each 3 week chemotherapy.
* have blood samples drawn to measure blood ascorbate levels once every 21 days
* have blood samples drawn to measure iron and ferritin levels before treatment, then on cycles 1 and 3.

The active therapy portion of this study lasts for 4 months. After that is completed, participants will go back to standard therapy for their cancer. Participants will continue to have life-long follow-up for this study.

Pharmacological Ascorbate for Lung Cancer

A Phase II Trial of High-Dose Ascorbate in Stage IV Non-Small Cell Lung Cancer

Data will be shared from those patient partners who agree to it. Data will be codified for the investigational team to provided additional details - as necessary - or confirm against source.

From cycle 1, day 1, to documented disease progression in CT imaging as described by RECIST criteria

The time (in months) it takes for disease to progress as defined by RECIST criteria. Timeframe will be from cycle 1, day 1 to date of progression.

Time, measured in months, from cycle 1 day 1 until date of death from any cause

Categorize and quantify using the Common Terminology Criteria for Adverse Events (CTCAE) v. 4 from cycle 1 day 1 through 1 month post-infusion

National Cancer Institute (NCI)

National Institutes of Health (NIH)

Holden Comprehensive Cancer Center

McGuff Pharmaceuticals, Inc.

Assistant Professor

Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov

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

Paclitaxel: - Administered intravenously (IV)

* Prescribed at 200 mg/m2 (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response

Carboplatin: - Administered intravenously (IV)

* Prescribed at AUC = 6 using the Cockcroft-Gault formula (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response

Ascorbic Acid: - Administered intravenously (IV)

* 75g per infusion
* Two infusions per week
* 1 cycle is 3 weeks
* given up to 4 cycles
* may be given while chemotherapy if delayed due to low counts

Spots Global Cancer Trial Database for Pharmacological Ascorbate for Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial