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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

No Placebo-Only Group

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.

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.

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 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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of grade 3, 4, & 5 adverse events during radiation

Secondary study objectives

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: NOS

12%

Late RT Toxicity: Other GI: NOS

12%

Hemoglobin decreased

12%

Alanine aminotransferase increased

Gynaecomastia

Urinary retention

Pain-other

Aspartate aminotransferase increased

Rectal bleeding

Constipation

Leukopenia NOS

Edema NOS

Hematuria present

Renal/GU-Other

Arthralgia

Blood creatinine increased

Dyspnea NOS

Dermatitis exfoliative NOS

Depression NEC

Nausea

Hyperglycemia NOS

Lymphopenia

Myalgia

Peripheral sensory neuropathy

Platelet count decreased

Hyponatremia

Hypocalcemia

Blood albumin decreased

Stomatitis

Weight decreased

Anorexia

Hematologic-Other

Neutropenia

Alopecia

100%

80%

60%

40%

20%

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

~1920

Radiation therapy

2013

Completed Phase 3

~2850