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

NCT02905591 | Active Not Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: 2017127703P30CA0868625U01CA1402061P01CA217797-01A1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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; Nonsmall Cell Lung Cancer; Non-Small-Cell Lung Carcinoma; NSCLC

Keywords

pharmacological ascorbate; ascorbic acid; radiation; chemotherapy; carboplatin; paclitaxel

Outcome Measures

Primary Outcomes (1)

• Progression rate at completion of radiation and chemotherapy

  Tumor measurement from CT scan, using the RECIST criteria to define progression

  3 to 4 weeks after last radiation treatment

Secondary Outcomes (4)

• Tumor response

  Every six months for up to 20 years post-treatment

• Progression free survival (PFS)

  Every six months for up to 20 years post-treatment

• Overall survival (OS)

  Every three months for up to 20 years post-treatment

• Adverse event frequency and categorization

  Weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment

Study Arms (1)

ChemoRT + Ascorbate

EXPERIMENTAL

Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)

Drug: Radiation Therapy; Drug: Paclitaxel; Drug: Carboplatin; Drug: Ascorbic Acid

Interventions

Radiation Therapy DRUG

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

Also known as: external beam radiation therapy (EBRT), intensity modulated radiation therapy (IMRT), Volumetric Arc Therapy (VMAT), XRT

ChemoRT + Ascorbate

Paclitaxel DRUG

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

Also known as: Nov-Onxol, Onxol, Paclitaxel Novaplus, Taxol

ChemoRT + Ascorbate

Carboplatin DRUG

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

Also known as: NovaPlus CARBOplatin, Amerinet Choice Carboplatin, Paraplatin, Paraplatin NovaPlus

ChemoRT + Ascorbate

Ascorbic Acid DRUG

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

Also known as: Ascorbate, Vitamin C, Pharmacological ascorbate

ChemoRT + Ascorbate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Note: patients who have a small pleural effusion that is too small to safety tap and is not visible on a chest x-ray are still eligible
• Pathologic diagnosis (i.e., cell sample, biopsy, tissue swap, bronchoscopy) of non-small cell lung cancer.
• Recommended to receive carboplatin \& paclitaxel with radiation therapy as a treatment
• Tumor or metastatic disease must measure at least 1 cm using a CT scan (CAT scan)
• Physician determined the patient is healthy enough for chemotherapy and radiation therapy
• At least part of the lung cancer must be viewable and measurable by CT or MRI
• A platelet count of at least 100,000 cells per mililiter
• A creatinine level of less than 1 1/2 times the upper limit of normal for the local lab test, or, a creatinine clearance of at least 60 mL/(min\*1.73m2)
• Not pregnant, and commit to using birth control during the study

You may not qualify if:

• Exudative pleural effusion
• Recurrent non-small cell lung cancer
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Patients actively receiving insulin or patients whose doctors have recommended current insulin use
• Patients requiring daily finger-stick blood glucose measurements
• Patients who are on the following drugs and cannot have a substitution or who decline the substitution:
• warfarin
• flecainide
• methadone
• amphetamines
• quinidine
• chlorpropamide
• Prior radiation therapy that would result in a field overlap
• Enrolled in another therapeutic clinical trial
• Uncontrolled, intercurrent illness

Sponsors & Collaborators

• Joseph J. Cullen, MD, FACS: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• Holden Comprehensive Cancer Center: collaborator

Study Sites (1)

Holden Comprehensive Cancer Cener

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, Cramer-Morales KL, Furqan M, Sandhu S, Carlisle TL, Smith MC, Abu Hejleh T, Berg DJ, Zhang J, Keech J, Parekh KR, Bhatia S, Monga V, Bodeker KL, Ahmann L, Vollstedt S, Brown H, Shanahan Kauffman EP, Schall ME, Hohl RJ, Clamon GH, Greenlee JD, Howard MA, Schultz MK, Smith BJ, Riley DP, Domann FE, Cullen JJ, Buettner GR, Buatti JM, Spitz DR, Allen BG. O2⋅- and H2O2-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate. Cancer Cell. 2017 Apr 10;31(4):487-500.e8. doi: 10.1016/j.ccell.2017.02.018. Epub 2017 Mar 30.

  PMID: 28366679 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy; Radiotherapy, Intensity-Modulated; Paclitaxel; Taxes; Carboplatin; Ascorbic Acid

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Coordination Complexes; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Joseph J Cullen, MD, FACS

  University of Iowa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Radiation Oncology

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: November 16, 2018
• Primary Completion: July 15, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon request.
• Access Criteria: Contact the investigator or sub-investigator to initiate a request. A contract may be required between institutions. Data will be shared only from those participants who consented to sharing.

Locations

US (1)