NCT02905591

A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC

A Phase 2 Trial of Pharmacological Ascorbate With Concurrent Chemotherapy and Radiation Therapy for Non-small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (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 a standard therapy for non-small cell lung cancer. The standard therapy is radiation therapy combined with carboplatin and paclitaxel (types of chemotherapy). All subjects will receive high-dose ascorbate in addition to the standard therapy.

Detailed description

For selected stages of non-small cell lung cancer (NSCLC), standard treatment involves radiation therapy and chemotherapy. The chemotherapy regimen typically used is paclitaxel and carboplatin. Both of these chemotherapeutic drugs are administered intravenously, using a vein in the arm. Radiation is administered using a machine external to the body (usually a linear accelerator). After combined therapy, NSCLC patients receive 2 extra cycles of chemotherapy, called "consolidation chemotherapy." This study adds 75 grams of ascorbate (vitamin C, sometimes called pharmacological ascorbate because the dose is so high) at specific timepoints in the therapy. The ascorbate is administered intravenously - through a vein in your arm. Participants will: * receive 75 grams of intravenous ascorbate 3 times per calendar week while they are receiving radiation therapy. The IV will be running while the radiation therapy is administered. * undergo imaging which is standard for their cancer and therapy. This can include CT scans, PET scans, and X-rays. * provide blood samples to determine the biological effects, if any, the ascorbate has on the body during therapy This active therapy portion lasts for about 10 to 12 weeks. After that is done, participants go back to standard follow-up for their cancer and any additional therapy their doctors believe they need. However, it is very important the investigators remain in contact with participants; they will have life-long follow-up for this study.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer
• Nonsmall Cell Lung Cancer
• Non-Small-Cell Lung Carcinoma
• NSCLC

Interventions

Type	Name	Description
DRUG	Radiation Therapy	Conformal radiation administered daily, Monday through Friday Total dose is 60 Gray (Gy) and is delivered in 2 Gy fractions. One fraction is delivered daily for a total of 30 fractions in 30 days
DRUG	Paclitaxel	Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered * the dose is 45 mg/m2 (standard dose) * Administered weekly * 6 to 7 weeks of therapy, depending on when radiation starts * Standardized dose reductions are used
DRUG	Carboplatin	Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done. * Prescribed at area-under-the-curve (AUC) = 2 using the Cockroft-Gault formula (standard) * Administered weekly * 6 to 7 weeks of therapy, depending on when radiation starts * Standard dose reductions are used
DRUG	Ascorbic Acid	Administered intravenously * 75 grams per infusion; each infusion is about 2 hours * 3 infusion per calendar week * The infusion is actively running for at least 20 minutes when radiation begins * May be given while chemotherapy is delayed due to low counts * Dose reductions are not used * Given for 6 to 7 weeks, depending on when radiation starts

Timeline

• Start date: 2018-11-16
• Primary completion: 2025-07-15
• Completion: 2027-12-31
• First posted: 2016-09-19
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study