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A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients (XACT-PANC-2)

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ClinicalTrials.gov Identifier: NCT03541486
Recruitment Status : Not yet recruiting
First Posted : May 30, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Joseph J. Cullen, University of Iowa

Brief Summary:
This is a phase 2 study testing the initial efficacy of adding pharmacological ascorbate (vitamin C) to standard radiation and chemotherapy for treatment of pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasm Drug: Ascorbate Drug: Gemcitabine Radiation: radiation therapy Phase 2

Detailed Description:

This phase 2 study is designed to determine the efficacy of adding pharmacological ascorbate (vitamin C) to standard chemoradiation. The ascorbate is infused before, during, and after the external beam radiation therapy treatment. Each ascorbate infusion is 75 grams (roughly the same amount of vitamin C from 1,000 oranges).

For patients eligible for this trial, standard treatment for their cancer includes radiation therapy combined with weekly gemcitabine (a chemotherapy).

Participants will:

  • receive pharmacological ascorbate intravenously ascorbate during their daily radiation therapy treatments. Radiation treatments are given once a day, Monday through Friday.
  • have routine doctor's visits and be asked about any side effects they are experiencing.

This is a phase 2 study to determine the effect, if any, adding pharmacological ascorbate will have on standard therapy for pancreatic cancer. The study will also record any side effects of adding ascorbate to standard therapy. Once the patient completes radiation, the ascorbate infusions are also completed. However, the patient will need to return for regular follow-up care at University of Iowa.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: XACT-Pancreas 2: Pharmacological Ascorbate, Gemcitabine, and Radiation Therapy for Pancreatic Cancer, Phase 2
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Concomitant Therapy
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
Drug: Ascorbate
75 gram infusion daily (M-F) on days when radiation therapy is administered
Other Names:
  • Ascor L 500
  • Pharmacological ascorbate
  • Vitamin C

Drug: Gemcitabine
600 mg/m2 once weekly for 6 weeks
Other Name: Gemzar

Radiation: radiation therapy
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.
Other Names:
  • Volumetric Arc Therapy (VMAT)
  • External beam radiation therapy




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 10 years post treatment ]
    The study will determine the time (calculated in months) between study day 1 and death from any cause. After 10 years post-treatment, dates will be censored to date of last follow-up


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 12 and 24 months post-treatment ]
    Objective response rate is defined as the number of partial response and complete response outcomes in the intent-to-treat population (partial and complete response are defined using the Response Evaluation Criteria in Solid Tumors (RECIST)).

  2. Progression free survival (PFS) [ Time Frame: Up to 10 years post-treatment ]
    From radiation day 1 to documented disease progression in CT imaging as described by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Measured in months.

  3. Toxicity over time (ToxT) [ Time Frame: Treatment day 1 to 30 days post-treatment ]
    Toxicity over time will be assessed by summarizing treatment emergent adverse events by system organ class and/or preferred term, type of adverse event, and severity. Elapsed days of toxicity will be summarized.


Other Outcome Measures:
  1. Exploration of patient reported outcomes during combined therapy [ Time Frame: During treatment phase (approximately 7 weeks) ]
    Patient completed quality of life (EORTC QLQ C-30 form) and symptom score forms (NCI's PRO-CTCAE) collected weekly.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet ALL of the following criteria:

  • Ability and willingness to provide informed consent (power of attorney and legally authorized representatives are not accepted for informed consent)
  • Stated willingness to comply with all study procedures and availability for duration of the study
  • At least 18 years of age
  • Histologic or cytologic diagnosis of pancreatic adenocarcinoma
  • Recommended to receive gemcitabine-based chemoradiation
  • Good performance status (ECOG of 0, 1, or 2; KPS of > 50)
  • No other active malignancy that requires immediate treatment. Low grown concurrent cancers are acceptable with the appropriate documentation from the treating oncologists for that additional primary disease.
  • 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).
  • Agree to abstain from alcohol and specified over the counter supplements during study treatment

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participating in this study:

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • HIV positive individuals requiring anti-retroviral drug therapy (high-dose ascorbate is known to interact with many of these drugs)
  • Platelet count of <100,000 k/mm3
  • Prior radiation that would result in field overlap (this will be determined by the study's radiation oncologist)
  • Actively receiving insulin
  • Other therapy (including radiation therapy) within 2 calendar weeks of study therapy
  • On any of the following drugs and cannot or will not accept a drug substitution: warfarin, flecainide, methadone, amphetamines, quinidine, and chlorpropamide
  • Other investigational agents (PET or SPECT imaging agents are acceptable)
  • Other investigational therapy with the intention to treat the disease under study
  • Pregnancy
  • Individuals declining to use acceptable birth control during the duration of the study
  • Lactating women who decline to discontinue breastfeeding their child (women may withhold breast feeding and resume under the direction of their medical oncologist after completion of study)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541486


Contacts
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Contact: Joseph J. Cullen, MD, FACS (319) 353-8297 joseph-cullen@uiowa.edu
Contact: Bryan G. Allen, MD, PhD (319) 356-3693 bryan-allen@uiowa.edu

Locations
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United States, Iowa
The University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Sandy Vollstedt, RN, BSN, OCN    319-353-7143    sandy-vollstedt@uiowa.edu   
Contact: Heather Brown, RN, BAN, OCN    319-384-7912    heather-brown@uiowa.edu   
Sponsors and Collaborators
Joseph J. Cullen
Holden Comprehensive Cancer Center
Investigators
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Principal Investigator: Joseph J. Cullen, MD, FACS University of Iowa

Publications:

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Responsible Party: Joseph J. Cullen, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03541486     History of Changes
Other Study ID Numbers: XACT-PANC-2
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD, including endpoints (OS, ORR, PFS, AE, and PROs), treatment information, and demographics.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Study protocol and consent will be shared after primary completion. Statistical analysis plan will be shared with results reporting. Data are available upon request and will be available for 2 years after the withdraw of the IND.
Access Criteria: An IRB-stamped signed usage agreement will be required in addition to a data sharing agreement between the academic centers. Interested researchers should contact Dr. Cullen or Dr. Allen.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joseph J. Cullen, University of Iowa:
ascorbic acid
ascorbate
sodium ascorbate
radiotherapy
radiotherapy, image-guided
gemcitabine
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs