Vitamin C + Radiation Therapy for Pancreatic Cancer

(XACT-PANC-2 Trial)

Overseen By Joseph Caster, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Joseph J. Cullen

Must be taking: Gemcitabine

Must not be taking: Warfarin, Flecainide, Methadone, others

Disqualifiers: G6PD deficiency, HIV, Insulin, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

Trial Summary

What is the purpose of this trial?

Radiation therapy improves cancer cure rates by killing cancer cells but it also contributes to long-term side effects in cancer survivors by unintentionally damaging normal organs such as the intestine. This research will what side effects patients with cancer experience, if high dose vitamin C helps reduce these side effects, and if high dose vitamin C increases the survival of patients with pancreatic cancer. We will meet with patients during the study to better understand their experience during their cancer treatment. In the long term, our research could provide a new way help cancer survivors avoid many permanent side effects of cancer treatments.

Research Team

Joseph Caster, MD, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for adults with pancreatic cancer who are referred for gemcitabine-based chemoradiation. They must not have other active cancers needing immediate treatment, uncontrolled illnesses, or be on certain medications like warfarin. Participants need to avoid alcohol and some supplements, have a good performance status, and agree to use birth control.

Inclusion Criteria

I am referred for treatment combining chemotherapy with radiation.

I don't have any other cancer needing immediate treatment.

Not experiencing an uncontrolled illness such as infection requiring inpatient admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other condition that would limit compliance with the study requirements or unacceptably increase risk to the participant (as determined by study team members).

Exclusion Criteria

I have not had any cancer treatment, including radiation, in the last 2 weeks.

I have G6PD deficiency.

I am HIV positive and on anti-retroviral therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gemcitabine chemotherapy weekly and daily radiation therapy, with some receiving additional pharmacological ascorbate

6 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for long-term side effects and quality of life impacts post-treatment

Up to 5 years

Regular follow-up visits

Treatment Details

Interventions

• Ascorbate
• Gemcitabine
• Radiation Therapy

Trial Overview The study tests if high-dose vitamin C (ascorbate) can reduce side effects of radiation therapy in pancreatic cancer patients and possibly improve survival rates. Patients will receive ascorbate alongside standard gemcitabine chemotherapy and radiation therapy.

Participant Groups

Group I: Investigational Therapy (ASC) Experimental Treatment 3 Interventions

75 grams of pharmacological ascorbate, daily (M-F) 600 mg/m2 of gemcitabine, once a week for up to 6 weeks 50 to 50.4 Gray of radiation therapy delivered using a volumetric arc therapy (VMAT) technique

Group II: Standard Therapy (ChemoRT) Active Control 2 Interventions

600 mg/m2 of gemcitabine, once a week for up to 6 weeks 50 to 50.4 Gray of radiation therapy delivered using a volumetric arc therapy (VMAT) technique

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in United States as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Who Is Running the Clinical Trial?

Joseph J. Cullen

Lead Sponsor

Trials

5

Recruited

100+

Joseph J. Cullen, MD, FACS

Lead Sponsor

Trials

4

Recruited

110+

Holden Comprehensive Cancer Center

Collaborator

Trials

27

Recruited

710+