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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

November 16, 2018

Primary Completion Date

July 17, 2025

Study Completion Date

December 31, 2027

Conditions
Carcinoma, Non-Small-Cell LungNon-Small Cell Lung CancerNonsmall Cell Lung CancerNon-Small-Cell Lung CarcinomaNSCLC
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"

Trial Locations (1)

52242

Holden Comprehensive Cancer Cener, Iowa City

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Holden Comprehensive Cancer Center

OTHER

lead

Joseph J. Cullen, MD, FACS

OTHER

NCT02905591 - A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC | Biotech Hunter | Biotech Hunter