A Research Trial of High Dose Vitamin C and Chemotherapy for Metastatic Pancreatic Cancer
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Purpose
This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have metastatic pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Neoplasms |
Drug: Gemcitabine with escalating ascorbic acid |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer |
- Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine) [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
- Plasma ascorbate level (targeted to 350 to 400 mg/dL) [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Survival [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 15 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ascorbate |
Drug: Gemcitabine with escalating ascorbic acid
Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic acid, given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbic acid per infusion Week 2: 25 grams ascorbic acid per infusion Week 3: 50 grams ascorbic acid per infusion Week 4: 75 grams ascorbic acid per infusion Week 5: 100 grams ascorbic acid per infusion Ascorbic acid infusion dose is maintained at the level that provides a serum level of 350-400 mg/dL. Other Names:
|
Detailed Description:
This is a phase I, dose-escalating study of ascorbic acid (vitamin C) designed to determine the maximum tolerated dose of vitamin C or, if well tolerated, the dose required to obtain a desired ascorbic acid plasma concentration.
Because this is a phase I study, prospective subjects should have advanced disease (i.e., metastasis) and have failed other curative therapies (or, are unable to receive curative therapies due to comorbidities or stage of disease).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Normal G6PD status
- Histologically or cytologically diagnosed pancreatic adenocarcinoma.
- Disease extent documented by CT scan (radiologically measurable disease is not required)
- Ambulatory patient without evidence of spinal cord compression
- No prior chemotherapy for metastatic disease
- Failed curative therapy or patient ineligible for definitive curative therapy
- Completed adjuvant therapy at least 4 weeks prior and recovered from any/all toxicities related to that treatment.
- If post-therapy, must have disease progression since that treatment
- If treated with prior radiation therapy, disease must be outside of the radiation fields
- No currently active second malignancies unless it is a non-melanoma skin cancer
- Women must be non-pregnant and non-lactating
- ECOG performance of 0, 1, or 2
- Granulocytes at least 1,500 / ul
- Platelets at least 100,000 / ul
- Creatinine less than 1.5 mg/dL or clearance of at least 60 mL / min
- Total bilirubin less than 2 times the upper limit of normal
- AST and ALT less than 3 times the upper limit of normal if liver metastases are not present. If liver metastases are present, AST and ALT less than 5 times the upper limit of normal
- PT INR less than 1.5 (unless the patient is on full dose warfarin)
- Patient must be at least 18 years of age
- Patient must be able to understand consent process, the research study, and be able to sign the consent document
Exclusion Criteria:
- A psychiatric disorder by history or examination that would prevent completion of the study
- ECOG performance of 3 or 4
- Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
- Consumption of excess alcohol (more than 4 drinks per day) or use of illicit drugs
- Continued sse of over-the-counter antioxidants (supplements like vitamin C and grape seeds)
Contacts and Locations| United States, Iowa | |
| The University of Iowa Hospitals & Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| Principal Investigator: | Joseph J Cullen, M.D. | The University of Iowa |
More Information
Publications:
| Responsible Party: | Joseph J. Cullen, Professor, University of Iowa |
| ClinicalTrials.gov Identifier: | NCT01049880 History of Changes |
| Other Study ID Numbers: | 200804753 |
| Study First Received: | January 14, 2010 |
| Last Updated: | April 17, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Iowa:
|
Ascorbic Acid Gemcitabine |
Additional relevant MeSH terms:
|
Neoplasms Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Ascorbic Acid Gemcitabine Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents |
Physiological Effects of Drugs Vitamins 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 May 19, 2013