Metastatic Pancreatic CancerPhase 1NCT00954525
Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer
A Phase 1 study testing Gemcitabine and Erlotinib and Intravenous Vitamin C in people with Metastatic Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Gemcitabine and Erlotinib and Intravenous Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic pancreatic cancer
- Glucose 6 phosphate dehydrogenase status normal
- ECOG performance status 0-2
- Normal creatinine and transaminase
- Women of child-bearing potential confirm negative pregnancy test
Who cannot join
- Concurrent chemotherapy or radiotherapy
- Significant co-morbid disorders
- Significant psychiatric symptoms
- Prior treatment with gemcitabine
- Concurrent chronic use of immunosuppressive agents (methotrexate, cyclosporine,corticosteroids)
- Regular use of nonsteroidal anti-inflammatory agents
Show all 11Show fewer
- Smoking more than 1 pack per day
- Excessive alcohol or drug use
- Enrollment in other experimental therapy
- Active infection
- Patients experiencing ongoing response to recent treatments
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson-Myrna Brind Center of Integrative Medicine
Philadelphia, Pennsylvania, 19107
About this study
Official title: Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer
Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Gemcitabine and Erlotinib, Intravenous Vitamin C
- Keywords
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine and ErlotinibDrug
Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)
Intravenous Vitamin CDietary supplement
50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Vitamin C | Experimental | Not described Receives: Drug: Gemcitabine and Erlotinib; Dietary Supplement: Intravenous Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.
Measured: 8 weeks
Secondary outcomes (1)
Progression-free survival
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Monti, MD, MBA, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954525
- Sponsor's protocol ID
- 09D.99
- Other IDs
- JT 1473
- Status last verified
- May 2025
- First submitted
- 4 Aug 2009
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00954525
- Acronym / sponsor ID
- 09D.99
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous Vitamin C | Experimental | Drug: Gemcitabine and Erlotinib, Dietary Supplement: Intravenous Vitamin C |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Metastatic pancreatic cancer
- Glucose 6 phosphate dehydrogenase status normal
- ECOG performance status 0-2
- Normal creatinine and transaminase
- Women of child-bearing potential confirm negative pregnancy test
Key exclusion criteria (11 listed)
- Concurrent chemotherapy or radiotherapy
- Significant co-morbid disorders
- Significant psychiatric symptoms
- Prior treatment with gemcitabine
- Concurrent chronic use of immunosuppressive agents (methotrexate, cyclosporine,corticosteroids)
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 |
|---|---|---|
| Gemcitabine and ErlotinibGemcitabine (dose according to study protocol), Erlotinib (100 mg/day) | Drug | Intravenous Vitamin C |
| Intravenous Vitamin C50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks. | Dietary supplement | Intravenous Vitamin C |
Primary outcome
Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.
Time frame: 8 weeks
1 secondary outcome
Progression-free survival
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Derived from this study: 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.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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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 Monti, MD, MBA principal investigator
Sidney Kimmel Comprehensive Cancer Center at 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 1 study testing Gemcitabine and Erlotinib and Intravenous Vitamin C in people with Metastatic Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality. (time frame: 8 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 NCT00954525, 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 2 May 2025.