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Pharmacological Ascorbate for Lung Cancer

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ClinicalTrials.gov Identifier: NCT02420314
Recruitment Status : Recruiting
First Posted : April 17, 2015
Last Update Posted : January 26, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Holden Comprehensive Cancer Center
McGuff Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Muhammad Furqan, University of Iowa

Brief 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.

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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of High-Dose Ascorbate in Stage IV Non-Small Cell Lung Cancer
Study Start Date : April 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ascorbate, paclitaxel, carboplatin
Paclitaxel, administered once per cycle (3 weeks) Carboplatin, administered once per cycle (3 weeks) Pharmacological ascorbate (ascorbic acid) infusions, 2 times per week for 3 weeks
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
Other Names:
  • Nov-Onxol
  • Onxol
  • Paclitaxel Novaplus
  • Taxol

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

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
Other Names:
  • Pharmacological ascorbate
  • Vitamin C
  • Ascorbate




Primary Outcome Measures :
  1. Tumor response [ Time Frame: every 2 months for up to 5 years post treatment ]
    From cycle 1, day 1, to documented disease progression in CT imaging as described by RECIST criteria


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: every 2 months for up to 5 years post treatment ]
    The time (in days) it takes for disease to progress as defined by RECIST criteria. Timeframe will be from cycle 1, day 1 to date of progression.

  2. Overall survival (OS) [ Time Frame: every 2 months for up to 5 years post treatment ]
    Time, measured in months, from cycle 1 day 1 until date of death from any cause

  3. Adverse Event Frequency [ Time Frame: monthly for up to 6 months ]
    Categorize and quantify using the Common Terminology Criteria for Adverse Events (CTCAE) v. 4 from cycle 1 day 1 through 1 month post-infusion



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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:

  • newly diagnosed stage IIIB or IV non -small cell lung cancer. The potential participant must not have received first-line cytotoxic therapy. Prior use of first-line EGFR inhibitors or ALK inhibitors is allowed if there was progression on therapy.
  • CNS metastasis is allowed if the metastasis is treated and there are no signs of progression following treatment. The potential participant must be off steroids for at least 3 days and be stable.
  • At least 18 years of age
  • ECOG performance status of 0, 1, or 2
  • absolute neutrophil count (ANC) of at least 1500 cells per mm³
  • platelet count of at least 100,000 cells per mm³
  • hemoglobin of at least 8 g/dL
  • creatinine within 1.5 times the upper limit of normal
  • total bilirubin within 1.5 times the upper limit of normal
  • ALT within 3 times the institutional upper limit of normal
  • AST within 3 times the institutional upper limit of normal
  • the participant must tolerate a 15g ascorbate test infusion (screening dose)
  • patients who received prior treatment with curative intent must have experienced a treatment-free interval of at least 6 months since the last treatment
  • the participant must not be pregnant, be willing to have a pregnancy test done if deemed necessary, and be willing to use adequate birth control during the study
  • not breastfeeding
  • independently able to provide consent (legally authorized representative and/or power of attorney is not allowed)

Exclusion Criteria:

  • known sensitizing EGFR mutations or ALK gene rearrangements if the participant has not yet tried EGFR or ALK inhibitor therapies. If the potential participant's biopsy did not allow for gene analysis (inconclusive, not enough tissue), the patient is considered eligible for the study. Enrollment on this clinical trial after progression on targeted therapy is allowed
  • 50% or greater PD-L1 expression (patients with unknown PD-L1 expression or when PD-L1 expression can't be determined due to insufficient tumor sample or other reasons remain eligible)
  • receiving warfarin therapy and cannot tolerate drug substitution
  • active hemoptysis within 1 week of screening (more than 1/2 teaspoon of blood per day)
  • actively receiving insulin at the time of ascorbate infusion
  • G6PD deficiency
  • leptomeningeal disease
  • potential participants cannot be on the following drugs: flecainide, methadone, amphetamines, quinidine, or chlorpropamide.
  • known active invasive malignancy other than the lung cancer under therapy (non-melanoma skin cancer or carcinoma in situ of the cervix or bladder are exempted)
  • potential participants may not enroll in, or be actively receiving treatment from, a therapeutic clinical trial for their cancer. Observational studies (including imaging studies) are acceptable.
  • uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness / social situations that would limit compliance with study requirements
  • known HIV positive individuals cannot be enrolled in this trial because high-dose ascorbate is a known CYP450 3A4 inducer, which results in lower serum levels of antiretroviral agents

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): NCT02420314


Contacts
Contact: Muhammad Furqan, M.B., B.S. (319) 356-1527 muhammad-furqan@uiowa.edu
Contact: Bryan Allen, MD, PhD (319) 356-3693 bryan-allen@uiowa.edu

Locations
United States, Iowa
Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Muhammad Furqan, M.B., B.S.    319-356-1527    muhammad-furqan@uiowa.edu   
Contact: Bryan Allen, MD, PhD    (319) 356-3693    bryan-allen@uiowa.edu   
Sub-Investigator: Daniel K Berg, MD         
Sub-Investigator: Taher Abu Hejleh, M.B., B.S.         
Sub-Investigator: Garry R Buettner, PhD         
Sub-Investigator: Brett Wagner, MA         
Sub-Investigator: Kalpaj Parekh, M.B., B.S.         
Sub-Investigator: Brian J. Smith, PhD         
Sub-Investigator: Sarah Bell, M.S.         
Sub-Investigator: Mary Schall, R.N., B.S.N         
Sub-Investigator: Kristin Varner, R.N.         
Sub-Investigator: Kellie Bodeker, MSHS, CCRC         
Sponsors and Collaborators
Muhammad Furqan
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Holden Comprehensive Cancer Center
McGuff Pharmaceuticals, Inc.
Investigators
Study Director: Joseph J. Cullen, MD, FACS University of Iowa

Publications of Results:
Responsible Party: Muhammad Furqan, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02420314     History of Changes
Other Study ID Numbers: 201412760
3P30CA086862 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: A plan for data sharing has not yet been developed.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Muhammad Furqan, University of Iowa:
Ascorbate
Ascorbic acid
Vitamin C
NSCLC
Non Small Cell Lung Cancer
carboplatin
paclitaxel

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vitamins
Ascorbic Acid
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents