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A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC (XACT-LUNG)

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ClinicalTrials.gov Identifier: NCT02905591
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : December 10, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Bryan Allen, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Non-Small Cell Lung Cancer Nonsmall Cell Lung Cancer Non-Small-Cell Lung Carcinoma NSCLC Drug: Radiation Therapy Drug: Paclitaxel Drug: Carboplatin Drug: Ascorbic Acid Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of Pharmacological Ascorbate With Concurrent Chemotherapy and Radiation Therapy for Non-small Cell Lung Cancer
Actual Study Start Date : November 16, 2018
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: ChemoRT + Ascorbate
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
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
Other Names:
  • external beam radiation therapy (EBRT)
  • intensity modulated radiation therapy (IMRT)
  • Volumetric Arc Therapy (VMAT)
  • XRT

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
Other Names:
  • Nov-Onxol
  • Onxol
  • Paclitaxel Novaplus
  • Taxol

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
Other Names:
  • NovaPlus CARBOplatin
  • Amerinet Choice Carboplatin
  • Paraplatin
  • Paraplatin NovaPlus

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
Other Names:
  • Ascorbate
  • Vitamin C
  • Pharmacological ascorbate




Primary Outcome Measures :
  1. Progression rate at completion of radiation and chemotherapy [ Time Frame: 3 to 4 weeks after last radiation treatment ]
    Tumor measurement from CT scan, using the RECIST criteria to define progression


Secondary Outcome Measures :
  1. Tumor response [ Time Frame: Every six months for up to 20 years post-treatment ]
    From radiation day 1 to documented disease progression as described by RECIST criteria. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST.

  2. Progression free survival (PFS) [ Time Frame: Every six months for up to 20 years post-treatment ]
    Time, measured in days, it takes for disease to progress, where disease progression is defined by the RECIST criteria (v1.1). Timeframe is from radiation day 1 to date of disease progression

  3. Overall survival (OS) [ Time Frame: Every three months for up to 20 years post-treatment ]
    Time, measured in months, from start of radiation to death from any cause.

  4. Adverse event frequency and categorization [ Time Frame: Weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment ]

    Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE, v 4) as follows:

    • Through radiation, weekly assessment of adverse events
    • Consolidation chemotherapy, assessment day 1 of each cycle
    • Post-treatment, every 6 months through 2 years post-therapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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) with non-small cell lung cancer.
  • Diagnosed within the past 4 weeks
  • 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 mL
  • 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

Exclusion Criteria:

  • Exudative pleural effusion
  • Recurrent non-small cell lung cancer
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Patients actively receiving insulin
  • 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
  • Lactating women
  • HIV positive individuals undergoing therapy due to known drug:drug interaction between antiretroviral drugs and high-dose ascorbate therapy

If all the above are met, the potential participant will receive a 15 gram challenge dose of ascorbate via intravenous infusion. This is the final screening procedure.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905591


Contacts
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Contact: Bryan G Allen, MD, PhD 319-353-8836 bryan-allen@uiowa.edu
Contact: Muhammad Furqan, MD 319-356-1527 muhammad-furqan@uiowa.edu

Locations
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United States, Iowa
Holden Comprehensive Cancer Cener Recruiting
Iowa City, Iowa, United States, 52242
Contact: Sandy Vollstedt, RN, BSN, OCN    319-353-7143    sandy-vollstedt@uiowa.edu   
Contact: Heather Brown, RN, BAN, OCN    319-384-7912    heather-brown@uiowa.edu   
Principal Investigator: Bryan G Allen, MD, PhD         
Principal Investigator: Muhammad Furqan, MD         
Sponsors and Collaborators
Joseph J. Cullen, MD, FACS
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Holden Comprehensive Cancer Center
Investigators
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Study Director: Joseph J Cullen, MD, FACS University of Iowa

Publications:
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Responsible Party: Bryan Allen, Assistant Professor, Department of Radiation Oncology, University of Iowa
ClinicalTrials.gov Identifier: NCT02905591     History of Changes
Other Study ID Numbers: 201712770
3P30CA086862 ( U.S. NIH Grant/Contract )
5U01CA140206 ( U.S. NIH Grant/Contract )
1P01CA217797-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be shared upon request in compliance with the IRB application and protocol.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bryan Allen, University of Iowa:
pharmacological ascorbate
ascorbic acid
radiation
chemotherapy
carboplatin
paclitaxel
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Ascorbic Acid
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances