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

Official record

Identifier

NCT02905591

Recruiting locations

country

United States

Interventions studied

Radiation TherapyPaclitaxelCarboplatinAscorbic Acid

Lead sponsor

Joseph J. Cullen, MD, FACS

Target enrolment

43 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Active, not recruiting

First posted

Sep 19, 2016

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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) 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

Exclusion Criteria:

* 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
* 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.