← Back to Search

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
No Placebo-Only Group

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 below
Select...
I have been diagnosed with pancreatic cancer, confirmed by tests and a CT scan.
Select...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My recent blood test shows my bone marrow is functioning well.
Select...
My kidney function is within the normal range.
Select...
I can tolerate a test dose of vitamin C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months for 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months for 2 years for reporting.

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 • NCT00004054
78%
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%
Platelet count decreased
1%
Blood albumin decreased
1%
Stomatitis
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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?

Joseph J. CullenLead Sponsor
4 Previous Clinical Trials
141 Total Patients Enrolled
Holden Comprehensive Cancer CenterOTHER
26 Previous Clinical Trials
779 Total Patients Enrolled
Gateway for Cancer ResearchOTHER
43 Previous Clinical Trials
2,515 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT01852890 — Phase 1
Pancreatic Cancer Research Study Groups: 75g Ascorbate, 25g Ascorbate, 50g Ascorbate, 100g Ascorbate
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT01852890 — Phase 1
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01852890 — Phase 1

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
Recent research and studies
~1 spots leftby Feb 2025