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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
Must not have
Known HIV-positive individuals. High-dose ascorbate acid is a known CYP450 3A4 inducer, which results in lower serum levels of antiretroviral drugs. A clinical trial designed to address these interaction issues is more appropriate than this phase 1 study
Patients actively receiving insulin are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months for 2 years
Awards & highlights

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
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV-positive and understand high-dose vitamin C may affect my HIV medication.
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I am not currently taking insulin.
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I have not had cancer other than non-melanoma skin cancer in the last 5 years.
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I have G6PD deficiency.
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I do not have any serious illnesses that would stop me from following the study's requirements.
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I've had recent therapy for cancer with minimal side effects.

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%
Stomatitis
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
2,532 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

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT01852890 — Phase 1
Pancreatic Cancer Research Study Groups: 75g Ascorbate, 100g Ascorbate, 50g Ascorbate, 25g 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
~1 spots leftby Jul 2025
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