Stage IV Pancreatic CancerPhase 2NCT01555489
Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca
A Phase 2 study testing Ascorbic Acid in people with Stage IV Pancreatic Cancer, run by Thomas Jefferson University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Pancreatic Cancer
- What is being tested?
- Ascorbic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jan 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females of age ≥ 18
- Histologically or cytologically confirmed pancreatic adenocarcinoma that has metastatic disease measurable by CT, MRI, or PET
- Subjects with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, biliary, gastrointestinal bypass) are eligible, if the subject has fully recovered from surgery and ≥ 14 days has passed since the operation. Patients with history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.
- ECOG performance status 0-2
- Laboratory values that would not prevent the patient from receiving chemotherapy as determined by the PI or study oncologist
- G6PD status ≥ lower limit of normal
- Serum creatinine ≤ 2.0 mg/dL
Who cannot join
- Islet cell or acinar cell carcinoma or cystadenocarcinoma
- History or known presence of central nervous system (CNS) metastases
- History of another primary cancer, except:
- Curatively treated cervical carcinoma in situ, or
- Curatively resected non-melanomatous skin cancer, or
- Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 3 years prior to enrollment
Show all 19Show fewer
- Other concurrent anticancer chemotherapy
- Prior radiotherapy ≤ 14 days, or if subjects have not recovered from radiotherapy
- Uncontrolled seizure disorder or other serious neurological diseases
- Any co-morbid disease that would increase risk of toxicity as determined by PI
- Only locally advanced disease
- Prior treatment with gemcitabine (for metastatic pancreatic cancer)
- Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids)
- Recent infection requiring a course of systemic anti-infection that was completed ≤ 14 days prior to enrollment (exception can be made at the judgment of the PI for oral treatment of an uncomplicated urinary tract infection ([UTI])
- History of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the PI, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study requirements
- Subject unwilling or unable to comply with study requirements
- Subject who is pregnant or breast feeding
- Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
- Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Phase II, Open Label Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer
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
Read the detailed description
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.
- Conditions
- Stage IV Pancreatic Cancer
- Being tested
- Ascorbic Acid
- Keywords
- Pancreatic Neoplasms, Pancreatic Cancer cells, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Endocrine Gland Neoplasms, Digestive System Diseases, Pancreatic Diseases, Endocrine System Diseases, Ascorbic Acid, Gemcitabine Vitamins, Vitamin C, Antioxidants, Molecular Mechanisms of Pharmacological Action, Pharmacologic Actions, Protective Agents, Physiological Effects of Drugs, Micronutrients, Growth Substances, Erlotinib
- Medical subject headings
- Pancreatic Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Endocrine Gland Neoplasms, Digestive System Diseases, Pancreatic Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called Vitamin C, Ascorbate
3x per week
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic Acid, Gemcitabine & Erlotinib | Experimental | Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer Receives: Drug: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Ascorbic Acid in Combination With Gemcitabine and Erlotinib for Stage IV Pancreatic Cancer
Safety: 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.
Measured: 15 weeks
Secondary outcomes (1)
Evaluate Quality of Life Using Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument
- 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.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel A Monti, MD, Principal investigator, Thomas Jefferson UniversityEdith P Mitchell, MD, Study chair, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555489
- Sponsor's protocol ID
- 11D.365
- Other IDs
- JT 2181
- Status last verified
- May 2025
- First submitted
- 22 Feb 2012
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Monti DA, Mitchell E, Bazzan AJ, Littman S, Zabrecky G, Yeo CJ, Pillai MV, Newberg AB, Deshmukh S, Levine M. Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One. 2012;7(1):e29794. doi: 10.1371/journal.pone.0029794. Epub 2012 Jan 17.
PubMed 22272248
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open Label Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01555489
- Acronym / sponsor ID
- 11D.365
- Conditions
- Stage IV Pancreatic Cancer
- Keywords
- Pancreatic Neoplasms, Pancreatic Cancer cells, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Endocrine Gland Neoplasms, Digestive System Diseases, Pancreatic Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Posted 28 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ascorbic Acid, Gemcitabine & Erlotinib | Experimental | Drug: Ascorbic AcidAscorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females of age ≥ 18
- Histologically or cytologically confirmed pancreatic adenocarcinoma that has metastatic disease measurable by CT, MRI, or PET
- Subjects with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, biliary, gastrointestinal bypass) are eligible, if the subject has fully recovered from surgery and ≥ 14 days has passed since the operation. Patients with history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.
- ECOG performance status 0-2
- Laboratory values that would not prevent the patient from receiving chemotherapy as determined by the PI or study oncologist
Key exclusion criteria (19 listed)
- Islet cell or acinar cell carcinoma or cystadenocarcinoma
- History or known presence of central nervous system (CNS) metastases
- History of another primary cancer, except:
- Curatively treated cervical carcinoma in situ, or
- Curatively resected non-melanomatous skin cancer, or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic AcidAlso: Vitamin C, Ascorbate3x per week | Drug | Ascorbic Acid, Gemcitabine & Erlotinib |
Primary outcome
Safety of Ascorbic Acid in Combination With Gemcitabine and Erlotinib for Stage IV Pancreatic Cancer
Time frame: 15 weeks
Safety: 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.
1 secondary outcome
Evaluate Quality of Life Using Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument
Time frame: 15 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22272248Monti DA, Mitchell E, Bazzan AJ, Littman S, Zabrecky G, Yeo CJ, Pillai MV, Newberg AB, Deshmukh S, Levine M. Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One. 2012;7(1):e29794. doi: 10.1371/journal.pone.0029794. Epub 2012 Jan 17.
- Phase I resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel A Monti, MD principal investigator
Thomas Jefferson University
Edith P Mitchell, MD study chair
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbic Acid in people with Stage IV Pancreatic Cancer, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Ascorbic Acid in Combination With Gemcitabine and Erlotinib for Stage IV Pancreatic Cancer (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01555489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.