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
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Paclitaxel Drug: Carboplatin Drug: Ascorbic Acid||Phase 2|
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.
- 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)|
|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|
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: Ascorbic Acid
- 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
- 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.
- 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
- 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
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
|Contact: Muhammad Furqan, M.B., B.S.||(319) firstname.lastname@example.org|
|Contact: Bryan Allen, MD, PhD||(319) email@example.com|
|United States, Iowa|
|Holden Comprehensive Cancer Center||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Muhammad Furqan, M.B., B.S. 319-356-1527 firstname.lastname@example.org|
|Contact: Bryan Allen, MD, PhD (319) 356-3693 email@example.com|
|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|
|Study Director:||Joseph J. Cullen, MD, FACS||University of Iowa|