Clinical trialEPhase 1Completed
Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery
A Pilot Study of Intravenous Ascorbic Acid and Folfirinox in the Treatment of Advanced Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- EPhase 1
- Status
- Completed
- Study type
- Interventional
- Start
- 18 October 2016
- Expected end
- March 2019
- Enrollment
- 8 participants
- Sites
- 1
- Primary outcomes
- Number of Participants With Adverse Events as Determined by CTCAE Version 4.03
- Sponsor
- Other
- Results posted
- 2020-01-18
- Last update
- 30 April 2025
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Brief summary public domain (ClinicalTrials.gov)
This pilot clinical trial studies the side effects of ascorbic acid and combination chemotherapy in treating patients with pancreatic cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Nutrients found in food and dietary supplements, such as ascorbic acid, may improve the tolerability of chemotherapy regimens. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may work better in treating patients with pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: I. To determine safety of intravenous ascorbic acid in combination with fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (FOLFIRINOX) as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 in patients with advanced pancreatic cancer. SECONDARY OBJECTIVES: I. To test feasibility of collecting quality of life (QOL), patient reported outcomes (PRO) data and correlative studies on patients with advanced pancreatic cancer.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Adverse Events as Determined by CTCAE Version 4.03 [Up to 28 days after the last treatment]. Count Of Participants, Participants. Grade 4 adverse event: Treatment (FOLFIRINOX, Ascorbic Acid) (n=8): 1. Grade 5 adverse event: Treatment (FOLFIRINOX, Ascorbic Acid) (n=8): 1. Grade 3 adverse event: Treatment (FOLFIRINOX, Ascorbic Acid) (n=8): 4. No Serious Adverse Events: Treatment (FOLFIRINOX, Ascorbic Acid) (n=8): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Change in Quality of Life as Defined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 [Baseline to up to 28 days after the last treatment]. Mean, score on a scale (Standard Deviation). Treatment (FOLFIRINOX, Ascorbic Acid) (n=8): NA (NA) [Due to the small number of participants, quality of life assessments were not looked at quantitatively. Attempts have been made to obtain additional information from the investigator but no information has been provided.].