Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01555489
First received: February 22, 2012
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA) plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic acid is safe when given with the chemotherapy. This Phase II trial is an initial test of efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line treatment. The phase I data suggests that ascorbic acid when given in combination with gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to better evaluate the response and confirm initial safety data


Condition Intervention Phase
Stage IV Pancreatic Cancer
Drug: Ascorbic Acid
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Open Label Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Safety of ascorbic acid in combination with gemcitabine and erlotinib for stage IV Pancreatic cancer [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
    To assess safety of IVAA in combination with gemcitabine and erlotinib by evaluating the number of adverse events and serious adverse events occurring among study participants

  • Efficacy of ascorbic acid in combination with gemcitabine and erlotinib for stage IV Pancreatic cancer [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    1. To assess efficacy of IVAA in combination with gemcitabine and erlotinib Partial response rate and progression free survival at 15 weeks will be assessed using RECIST criteria, and compared to the well-documented rates observed in previously published studies and historical dataset at Jefferson in patients treated with gemcitabine plus erlotinib alone.


Secondary Outcome Measures:
  • quality of life [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    1) To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire as well as the Patient Reported Outcomes Measurement Information System (PROMIS-29) will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G and PROMIS-29 will be summarized at multiple time points using means and standard deviations.


Estimated Enrollment: 35
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ascorbic Acid Drug: Ascorbic Acid
3x per week
Other Names:
  • Vitamin C
  • Ascorbate

Detailed Description:

Intravenous high dose ascorbic acid is a widely used alternative cancer treatment. Patients will receive standard care gemcitabine/erlotinib for treatment of their metastatic pancreatic adenocarcinoma. They will be closely monitored for disease response/ progression. If vitamin C has a beneficial effect on tumour cells, patients may experience a regression of tumor or tumor markers. Additional benefits include scans at no charge to the patient. This study requires several days of treatment per week and treatments are given in two different locations. The intravenous vitamin C treatments are given 3 times per week, these are given every week for an initial cycle of 15 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females of age ≥ 18
  • Histologically or cytologically confirmed pancreatic adenocarcinoma that has metastatic disease measurable by CT, MRI, or PET
  • Subjects with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, biliary, gastrointestinal bypass) are eligible, if the subject has fully recovered from surgery and ≥ 14 days has passed since the operation. Patients with history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.
  • ECOG performance status 0-2
  • Laboratory values that would not prevent the patient from receiving chemotherapy as determined by the PI or study oncologist
  • G6PD status ≥ lower limit of normal
  • Serum creatinine ≤ 2.0 mg/dL

Exclusion Criteria:

  • Islet cell or acinar cell carcinoma or cystadenocarcinoma
  • History or known presence of central nervous system (CNS) metastases
  • History of another primary cancer, except:
  • Curatively treated cervical carcinoma in situ, or
  • Curatively resected non-melanomatous skin cancer, or
  • Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 3 years prior to enrollment
  • Other concurrent anticancer chemotherapy
  • Prior radiotherapy ≤ 14 days, or if subjects have not recovered from radiotherapy
  • Uncontrolled seizure disorder or other serious neurological diseases
  • Any co-morbid disease that would increase risk of toxicity as determined by PI
  • Only locally advanced disease
  • Prior treatment with gemcitabine (for metastatic pancreatic cancer)
  • Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids)
  • Recent infection requiring a course of systemic anti-infection that was completed ≤ 14 days prior to enrollment (exception can be made at the judgment of the PI for oral treatment of an uncomplicated urinary tract infection ([UTI])
  • History of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the PI, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study requirements
  • Subject unwilling or unable to comply with study requirements
  • Subject who is pregnant or breast feeding
  • Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
  • Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555489

Contacts
Contact: Michael J Matthews 215-503-7329 michael.matthews@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Michael J Matthews    215-503-7329    michael.matthews@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Daniel A Monti, MD Thomas Jefferson University
Study Chair: Edith P Mitchell, MD Thomas Jefferson University
  More Information

Additional Information:
Publications:
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01555489     History of Changes
Other Study ID Numbers: 11D.365
Study First Received: February 22, 2012
Last Updated: March 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Pancreatic Diseases
Pancreatic Neoplasms
Pancreatic Cancer cells
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Ascorbic Acid
Gemcitabine Vitamins
Vitamin C
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Erlotinib
Integrative Medicine
Alternative Medicine
Complementary Medicine

Additional relevant MeSH terms:
Pancreatic Diseases
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Ascorbic Acid
Vitamins
Gemcitabine
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antioxidants
Pharmacologic Actions
Protective Agents
Micronutrients
Growth Substances
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 31, 2014