16 Participants Needed

Gemcitabine + Vitamin C + Radiation for Pancreatic Cancer

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate (vitamin C) to standard radiation and chemotherapy for treatment of pancreatic cancer.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as insulin and specific drugs like flecainide, methadone, amphetamines, quinidine, and chlorpropamide, unless a substitution can be made. If you are on these medications, you may need to discuss alternatives with your doctor.

Is the combination of Gemcitabine and radiation therapy safe for humans?

Studies show that Gemcitabine combined with radiation therapy is generally safe for treating pancreatic and non-small-cell lung cancer, but the safety depends on the dose and schedule. Careful management of radiation fields and Gemcitabine doses is important to minimize side effects.12345

What makes the Gemcitabine + Vitamin C + Radiation treatment unique for pancreatic cancer?

This treatment is unique because it combines Gemcitabine, a drug that makes cancer cells more sensitive to radiation, with Vitamin C and radiation therapy, potentially enhancing the effectiveness of the treatment compared to using Gemcitabine or radiation alone.678910

What data supports the effectiveness of the treatment Gemcitabine combined with radiation therapy for pancreatic cancer?

Research shows that Gemcitabine, when combined with radiation therapy, is effective in treating localized, unresectable pancreatic cancer. Studies indicate that Gemcitabine has radiosensitizing properties, meaning it can make cancer cells more sensitive to radiation, potentially improving treatment outcomes.1261011

Who Is on the Research Team?

JJ

Joseph J Cullen, MD, FACS

Principal Investigator

The University of Iowa Hospitals & Clinics

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Not pregnant
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.
See 12 more

Exclusion Criteria

I have G6PD deficiency.
Pregnant or lactating women: The risks of radiation and chemotherapy to a fetus are well documented
I am HIV-positive and understand high-dose vitamin C may affect my HIV medication.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high doses of intravenous ascorbate during daily radiation therapy treatments, along with weekly gemcitabine

5-6 weeks
Daily visits (Monday through Friday)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with adverse events assessed monthly

2 years
Every 3 months

Long-term follow-up

Participants are monitored for disease progression and overall survival

Up to 10 years
Monthly

What Are the Treatments Tested in This Trial?

Interventions

  • Ascorbate
  • Gemcitabine
  • Radiation therapy
Trial Overview 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.
How Is the Trial Designed?
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.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joseph J. Cullen

Lead Sponsor

Trials
5
Recruited
100+

Gateway for Cancer Research

Collaborator

Trials
47
Recruited
2,500+

Holden Comprehensive Cancer Center

Collaborator

Trials
27
Recruited
710+

Published Research Related to This Trial

In a Phase II study involving 28 patients with unresectable locally advanced pancreatic cancer, the combination of weekly Gemcitabine and external beam radiotherapy was found to be safe, with 86% of patients completing the treatment despite some experiencing significant toxicities.
The treatment resulted in a median survival time of 10.3 months, with 21% of patients showing a partial response and 57% maintaining stable disease, indicating potential efficacy in managing this challenging cancer type.
A phase II study of gemcitabine in combination with radiation therapy in patients with localized, unresectable, pancreatic cancer: a Hoosier Oncology Group study.Cardenes, HR., Moore, AM., Johnson, CS., et al.[2022]
In a systematic review of four studies involving 336 participants, combining gemcitabine with radiotherapy did not improve overall survival or progression-free survival compared to gemcitabine alone.
However, the addition of radiotherapy led to a higher incidence of severe side effects, such as anemia and fatigue, indicating that this combination may not be safe or beneficial for patients with pancreatic cancer.
Is concomitant radiotherapy necessary with gemcitabine-based chemotherapy in pancreatic cancer?Zhang, X., Huang, HJ., Feng, D., et al.[2022]
In a study of 41 patients with nonmetastatic pancreatic cancer, full-dose gemcitabine combined with radiation therapy was found to be well tolerated, with manageable side effects such as grade 3 neutropenia, nausea, and vomiting.
The treatment led to a significant reduction in CA 19-9 levels and a one-year survival rate of 73%, suggesting that this regimen could be effective and warrants further investigation in larger trials.
Full-dose gemcitabine with concurrent radiation therapy in patients with nonmetastatic pancreatic cancer: a multicenter phase II trial.Small, W., Berlin, J., Freedman, GM., et al.[2022]

Citations

A phase II study of gemcitabine in combination with radiation therapy in patients with localized, unresectable, pancreatic cancer: a Hoosier Oncology Group study. [2022]
Phase II study of gemcitabine combined with radiation therapy in patients with localized, unresectable pancreatic cancer. [2022]
Combining gemcitabine with radiation in pancreatic cancer: understanding important variables influencing the therapeutic index. [2022]
Is concomitant radiotherapy necessary with gemcitabine-based chemotherapy in pancreatic cancer? [2022]
Adjuvant radiotherapy and chemoradiation with gemcitabine after R1 resection in patients with pancreatic adenocarcinoma. [2022]
Full-dose gemcitabine with concurrent radiation therapy in patients with nonmetastatic pancreatic cancer: a multicenter phase II trial. [2022]
Optimizing chemoradiation in locally advanced non-small-cell lung cancer. [2022]
Chemoradiation in NSCLC: focus on the role of gemcitabine. [2022]
Postoperative adjuvant gemcitabine and concurrent radiation after curative resection of pancreatic head carcinoma: a phase II study. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Cancer and leukemia group B (CALGB) 89805: phase II chemoradiation trial using gemcitabine in patients with locoregional adenocarcinoma of the pancreas. [2022]
[Radiochemotherapy with gemcitabine and cisplatin in pancreatic cancer -- feasible and effective]. [2022]
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