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Anti-metabolites
Gemcitabine + Vitamin C + Radiation for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Joseph J Cullen, MD, FACS
Research Sponsored by Joseph J. Cullen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically or cytologically diagnosed pancreatic adenocarcinoma. Documentation of disease extent by CT scan is required. Radiologically measurable disease is not required.
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months for 2 years
Awards & highlights
Study Summary
This trial is testing if it's safe to give pancreatic cancer patients high doses of vitamin C in addition to their regular radiation and chemotherapy treatments.
Who is the study for?
This trial is for adults over 18 with pancreatic adenocarcinoma, who can tolerate a test dose of vitamin C and have normal liver function, blood clotting, kidney function, and white blood cell count. They must not be pregnant or on certain drugs like insulin or methadone that can't be replaced.Check my eligibility
What is being tested?
The study tests the safety of high-dose vitamin C combined with standard chemotherapy (Gemcitabine) and radiation therapy in treating pancreatic cancer. It's an early-stage trial to see if this mix is safe for patients.See study design
What are the potential side effects?
Potential side effects may include reactions to high doses of vitamin C such as digestive discomfort or allergic reactions, plus typical chemotherapy and radiation therapy side effects like fatigue, nausea, skin irritation at the treatment site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with pancreatic cancer, confirmed by tests and a CT scan.
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I am 18 years old or older.
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My kidney function is within the normal range.
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I can take care of myself but might not be able to do heavy physical work.
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I can tolerate a test dose of vitamin C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 months for 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months for 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of grade 3, 4, & 5 adverse events during radiation
Secondary outcome measures
Number of grade 3, 4, & 5 adverse events post-treatment
Overall survival
Time to progression
Side effects data
From 2013 Phase 3 trial • 397 Patients • NCT0000405478%
Menopausal symptoms
60%
Urinary frequency
52%
Impotence
47%
Late RT Toxicity: Bladder: NOS
39%
Diarrhea NOS
27%
Late RT Toxicity: Bowel: NOS
26%
Fatigue
26%
Late RT Toxicity: Other GU: NOS
21%
Proctitis NOS
21%
Dysuria
14%
Libido decreased
14%
Dermatitis radiation NOS
12%
Late RT Toxicity: Other GI: NOS
12%
Late RT Toxicity: Other: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Nausea
2%
Hyperglycemia NOS
2%
Depression NEC
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Stomatitis
1%
Platelet count decreased
1%
Blood albumin decreased
1%
Weight decreased
1%
Anorexia
1%
Hypocalcemia
1%
Hyponatremia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy
Trial Design
4Treatment groups
Experimental Treatment
Group I: 75g AscorbateExperimental Treatment3 Interventions
If the 50g arm is tolerated, the study opens the 75g arm.
Radiation: Prescribed to either 50 Gy in 25 fractions or at least 50.4 Gy in 28 fractions, based on tumor. Radiation is delivered 1 fraction/day, 5 days a week, for approximately 5 to 6 weeks.
Gemcitabine: 600 mg/m2, once weekly for 6 weeks.
Ascorbate: 75 grams administered intravenously (by IV) during radiation therapy, for approximately 5 to 6 weeks.
Group II: 50g AscorbateExperimental Treatment3 Interventions
This arm is the initial starting dose. The first study participant will be assigned the 50g ascorbate arm.
Radiation: Prescribed to either 50 Gy in 25 fractions or at least 50.4 Gy in 28 fractions, based on tumor. Radiation is delivered 1 fraction/day, 5 days a week, for approximately 5 to 6 weeks.
Gemcitabine: 600 mg/m2, once weekly for 6 weeks.
Ascorbate: 50 grams administered intravenously (by IV) during radiation therapy, for approximately 5 to 6 weeks.
Group III: 25g AscorbateExperimental Treatment3 Interventions
This study arm will only be used if participants cannot tolerate the 50g arm. If participants cannot tolerate 50 grams of Ascorbate, the 25g arm is opened.
Radiation: Prescribed to either 50 Gy in 25 fractions or at least 50.4 Gy in 28 fractions, based on tumor. Radiation is delivered 1 fraction/day, 5 days a week, for approximately 5 to 6 weeks.
Gemcitabine: 600 mg/m2, once weekly for 6 weeks.
Ascorbate: 25 grams administered intravenously (by IV) during radiation therapy, for approximately 5 to 6 weeks.
Group IV: 100g AscorbateExperimental Treatment3 Interventions
If the 75g arm is tolerated, the study opens the 100g arm.
Radiation: Prescribed to either 50 Gy in 25 fractions or at least 50.4 Gy in 28 fractions, based on tumor. Radiation is delivered 1 fraction/day, 5 days a week, for approximately 5 to 6 weeks.
Gemcitabine: 600 mg/m2, once weekly for 6 weeks.
Ascorbate: 100 grams administered intravenously (by IV) during radiation therapy, for approximately 5 to 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Radiation therapy
2013
Completed Phase 3
~2850
Find a Location
Who is running the clinical trial?
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,554 Total Patients Enrolled
Joseph J. CullenLead Sponsor
4 Previous Clinical Trials
141 Total Patients Enrolled
Holden Comprehensive Cancer CenterOTHER
26 Previous Clinical Trials
761 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have G6PD deficiency.I am 18 years old or older.I am HIV-positive and understand high-dose vitamin C may affect my HIV medication.I can take care of myself but might not be able to do heavy physical work.You have at least 100,000 platelets per cubic millimeter of blood.I have been diagnosed with pancreatic cancer, confirmed by tests and a CT scan.Your blood test results must be within a certain range within 21 days before starting radiation treatment.I have not had cancer other than non-melanoma skin cancer in the last 5 years.You have a low count of a type of white blood cells called leukocytes.My recent blood test shows my bone marrow is functioning well.Your body has enough infection-fighting white blood cells.Your AST blood test result is not more than 2.5 times the upper limit of normal.I am not currently taking insulin.I have had radiotherapy in the abdomen that might overlap with new treatment areas.My kidney function is within the normal range.I do not have any serious illnesses that would stop me from following the study's requirements.I can tolerate a test dose of vitamin C.I am taking flecainide, methadone, amphetamines, quinidine, or chlorpropamide and cannot switch medications.Your blood clotting tests are normal.I've had recent therapy for cancer with minimal side effects.You are currently taking experimental treatments for the same disease being studied, unless it is for observation or imaging purposes.Your ALT level is not more than 2.5 times the normal limit.Your total bilirubin level should be less than two times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: 75g Ascorbate
- Group 2: 100g Ascorbate
- Group 3: 50g Ascorbate
- Group 4: 25g Ascorbate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned irradiation therapy for medical use?
"Radiation therapy has not been extensively tested, and thus received a score of 1 on our safety scale at Power. This indicates that while there is limited data regarding its efficacy, the risk posed by this treatment is minimal."
Answered by AI
Are recruitments for this research endeavor still being accepted?
"Unfortunately, the study mentioned is no longer recruiting. It was initially posted on January 1st 2014 and last updated July 21st 2022 - if you are looking for other trials however, there are 580 studies that involve cancer of pancreas and 494 Radiation therapy clinical trials currently accepting patients."
Answered by AI
In what circumstances is radiation therapy most typically prescribed?
"Radiation therapy has proven to be an effective treatment option for small cell lung cancer (SCLC), head and neck carcinoma, as well as cervical cancers."
Answered by AI
Are there any other experiments that have employed Radiation therapy in the past?
"At the moment, 494 clinical trials are underway that explore Radiation therapy. Of those in operation, 142 sit at Phase 3 of testing. The epicentre for these experiments is Woolloongabba, Queensland; however there are over 25 thousand other sites actively researching this intervention."
Answered by AI
What is the participant capacity for this research endeavor?
"Unfortunately, this research project is not currently recruiting. Originally posted on January 1st 2014, and last updated July 21st 2022; if you are in search of further studies related to pancreatic cancer or radiation therapy there are 580 and 494 trials respectively seeking participants right now."
Answered by AI
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