NCT02420314

Pharmacological Ascorbate for Lung Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Joseph J. Cullen, MD, FACS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	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
DRUG	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
DRUG	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

Timeline

• Start date: 2015-04-01
• Primary completion: 2021-12-01
• Completion: 2022-08-27
• First posted: 2015-04-17
• Last updated: 2024-08-20
• Results posted: 2024-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study