Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca
The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA) plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic acid is safe when given with the chemotherapy. This Phase II trial is an initial test of efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line treatment. The phase I data suggests that ascorbic acid when given in combination with gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to better evaluate the response and confirm initial safety data
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II, Open Label Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer|
- Safety of ascorbic acid in combination with gemcitabine and erlotinib for stage IV Pancreatic cancer [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]To assess safety of IVAA in combination with gemcitabine and erlotinib by evaluating the number of adverse events and serious adverse events occurring among study participants
- Efficacy of ascorbic acid in combination with gemcitabine and erlotinib for stage IV Pancreatic cancer [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]1. To assess efficacy of IVAA in combination with gemcitabine and erlotinib Partial response rate and progression free survival at 15 weeks will be assessed using RECIST criteria, and compared to the well-documented rates observed in previously published studies and historical dataset at Jefferson in patients treated with gemcitabine plus erlotinib alone.
- quality of life [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]1) To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire as well as the Patient Reported Outcomes Measurement Information System (PROMIS-29) will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G and PROMIS-29 will be summarized at multiple time points using means and standard deviations.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
|Experimental: Ascorbic Acid||
Drug: Ascorbic Acid
3x per week
Intravenous high dose ascorbic acid is a widely used alternative cancer treatment. Patients will receive standard care gemcitabine/erlotinib for treatment of their metastatic pancreatic adenocarcinoma. They will be closely monitored for disease response/ progression. If vitamin C has a beneficial effect on tumour cells, patients may experience a regression of tumor or tumor markers. Additional benefits include scans at no charge to the patient. This study requires several days of treatment per week and treatments are given in two different locations. The intravenous vitamin C treatments are given 3 times per week, these are given every week for an initial cycle of 15 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555489
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Daniel A Monti, MD||Thomas Jefferson University|
|Study Chair:||Edith P Mitchell, MD||Thomas Jefferson University|