Pancreatic NeoplasmsPhase 1NCT01049880
A Research Trial of High Dose Vitamin C and Chemotherapy for Metastatic Pancreatic Cancer
A Phase 1 study testing Gemcitabine with escalating ascorbic acid in people with Pancreatic Neoplasms, run by Joseph J. Cullen at 1 site in United States.
Trial summary
This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Gemcitabine with escalating ascorbic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Mar 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Normal G6PD status
- Histologically or cytologically diagnosed pancreatic adenocarcinoma.
- Disease extent documented by CT scan (radiologically measurable disease is not required)
- Ambulatory patient without evidence of spinal cord compression
- No prior chemotherapy for metastatic disease
- Failed curative therapy or patient ineligible for definitive curative therapy
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- Completed adjuvant therapy at least 4 weeks prior and recovered from any/all toxicities related to that treatment.
- If post-therapy, must have disease progression since that treatment
- If treated with prior radiation therapy, disease must be outside of the radiation fields
- No currently active second malignancies unless it is a non-melanoma skin cancer
- Women must be non-pregnant and non-lactating
- ECOG performance of 0, 1, or 2
- Granulocytes at least 1,500 / ul
- Platelets at least 100,000 / ul
- Creatinine less than 1.5 mg/dL or clearance of at least 60 mL / min
- Total bilirubin less than 2 times the upper limit of normal
- AST and ALT less than 3 times the upper limit of normal if liver metastases are not present. If liver metastases are present, AST and ALT less than 5 times the upper limit of normal
- PT INR less than 1.5 (unless the patient is on full dose warfarin)
- Patient must be at least 18 years of age
- Patient must be able to understand consent process, the research study, and be able to sign the consent document
Who cannot join
- A psychiatric disorder by history or examination that would prevent completion of the study
- ECOG performance of 3 or 4
- Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
- Consumption of excess alcohol (more than 4 drinks per day) or use of illicit drugs
- Continued sse of over-the-counter antioxidants (supplements like vitamin C and grape seeds)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
About this study
Official title: A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer
This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have metastatic pancreatic cancer.
Read the detailed description
This is a phase I, dose-escalating study of ascorbic acid (vitamin C) designed to determine the maximum tolerated dose of vitamin C or, if well tolerated, the dose required to obtain a desired ascorbic acid plasma concentration.
Because this is a phase I study, prospective subjects should have advanced disease (i.e., metastasis) and have failed other curative therapies (or, are unable to receive curative therapies due to comorbidities or stage of disease).
- Conditions
- Pancreatic Neoplasms
- Being tested
- Gemcitabine with escalating ascorbic acid
- Keywords
- Ascorbic Acid, Gemcitabine
- 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 with escalating ascorbic acidDrug
Also called Gemzar, Ascor L 500
Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic acid, given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbic acid per infusion Week 2: 25 grams ascorbic acid per infusion Week 3: 50 grams ascorbic acid per infusion Week 4: 75 grams ascorbic acid per infusion Week 5: 100 grams ascorbic acid per infusion
Ascorbic acid infusion dose is maintained at the level that provides a serum level of 350-400 mg/dL.
| Study group | Role | What they receive |
|---|---|---|
| Ascorbate | Experimental | Not described Receives: Drug: Gemcitabine with escalating ascorbic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine)
Measured: weekly
Secondary outcomes (2)
Plasma ascorbate level (targeted to 350 to 400 mg/dL)
Measured: Weekly
Survival
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionFeb 2013
- Study completionMar 2013
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 Pancreatic NeoplasmsStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph J. Cullen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, Holden Comprehensive Cancer Center
- Responsible party
- Sponsor-investigator, Joseph J. Cullen, University of Iowa
- Investigators
- Joseph J Cullen, M.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049880
- Sponsor's protocol ID
- 200804753
- Status last verified
- Apr 2017
- First submitted
- 14 Jan 2010
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Welsh JL, Wagner BA, van't Erve TJ, Zehr PS, Berg DJ, Halfdanarson TR, Yee NS, Bodeker KL, Du J, Roberts LJ 2nd, Drisko J, Levine M, Buettner GR, Cullen JJ. Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancreatic cancer (PACMAN): results from a phase I clinical trial. Cancer Chemother Pharmacol. 2013 Mar;71(3):765-75. doi: 10.1007/s00280-013-2070-8. Epub 2013 Feb 5.
PubMed 23381814
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01049880
- Acronym / sponsor ID
- 200804753
- Conditions
- Pancreatic Neoplasms
- Keywords
- Ascorbic Acid, Gemcitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Joseph J. CullenUniversity, hospital or other
- Collaborators
- University of Iowa, Holden Comprehensive Cancer Center
- Study start
- Dec 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Jan 2010 (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.
This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have metastatic pancreatic cancer.
Detailed description
This is a phase I, dose-escalating study of ascorbic acid (vitamin C) designed to determine the maximum tolerated dose of vitamin C or, if well tolerated, the dose required to obtain a desired ascorbic acid plasma concentration.
Because this is a phase I study, prospective subjects should have advanced disease (i.e., metastasis) and have failed other curative therapies (or, are unable to receive curative therapies due to comorbidities or stage of disease).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ascorbate | Experimental | Drug: Gemcitabine with escalating ascorbic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Normal G6PD status
- Histologically or cytologically diagnosed pancreatic adenocarcinoma.
- Disease extent documented by CT scan (radiologically measurable disease is not required)
- Ambulatory patient without evidence of spinal cord compression
- No prior chemotherapy for metastatic disease
Key exclusion criteria (5 listed)
- A psychiatric disorder by history or examination that would prevent completion of the study
- ECOG performance of 3 or 4
- Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
- Consumption of excess alcohol (more than 4 drinks per day) or use of illicit drugs
- Continued sse of over-the-counter antioxidants (supplements like vitamin C and grape seeds)
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 with escalating ascorbic acidAlso: Gemzar, Ascor L 500Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic acid, given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbic acid per infusion Week 2: 25 grams ascorbic acid per infusion Week 3: 50 grams ascorbic acid per infusion Week 4: 75 grams ascorbic acid per infusion Week 5: 100 grams ascorbic acid per infusion Ascorbic acid infusion dose is maintained at the level that provides a serum level of 350-400 mg/dL. | Drug | Ascorbate |
Primary outcome
Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine)
Time frame: weekly
2 secondary outcomes
Plasma ascorbate level (targeted to 350 to 400 mg/dL)
Time frame: Weekly
Survival
Time frame: Ongoing
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 21 Apr 2017.
- Results publication: PubMed 23381814Welsh JL, Wagner BA, van't Erve TJ, Zehr PS, Berg DJ, Halfdanarson TR, Yee NS, Bodeker KL, Du J, Roberts LJ 2nd, Drisko J, Levine M, Buettner GR, Cullen JJ. Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancreatic cancer (PACMAN): results from a phase I clinical trial. Cancer Chemother Pharmacol. 2013 Mar;71(3):765-75. doi: 10.1007/s00280-013-2070-8. Epub 2013 Feb 5.
- Study results, free article.Link 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.
Joseph J Cullen, M.D. principal investigator
University of Iowa
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 with escalating ascorbic acid in people with Pancreatic Neoplasms, run by Joseph J. Cullen 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 20 inclusion and 5 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 21 Apr 2017. 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?
Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine) (time frame: weekly). 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 NCT01049880, 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 21 Apr 2017.