CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Paclitaxel +2 moredrug
Likely dose
Paclitaxel 200 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02420314
NCT02420314Phase 2Completed
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A Phase II Trial of High-Dose Ascorbate in Stage IV Non-Small Cell Lung Cancer

Joseph J. Cullen, MD, FACS·interventional·Posted Apr 17, 2015·Updated Aug 20, 2024

In Brief

A Phase 2 clinical trial evaluating Paclitaxel, Carboplatin, and 1 other intervention for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), National Institutes of Health (NIH), Holden Comprehensive Cancer Center, McGuff Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 17, 2015
Enrollment StartApr 1, 2015
Primary CompletionDec 1, 2021
Study CompletionAug 27, 2022
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 11.2 years ago

Interventions

Paclitaxeldrug

* 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

Carboplatindrug

* 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

Ascorbic Aciddrug

* 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