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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• Holden Comprehensive Cancer Center

  collaborator OTHER

• Joseph J. Cullen, MD, FACS

  lead OTHER

Principal Investigators

• Joseph J Cullen, MD, FACS · University of Iowa

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-16

Primary Completion

2025-07-15

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations