Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 6/22/2018 |
| Start Date: | July 2009 |
| End Date: | December 2011 |
Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer
Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis
with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging
(MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation
therapy. Full inclusion/exclusion criteria are available. History and physical examination,
and laboratory and imaging analyses will be done within 14 days prior to registration. The
three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid,
three times per week for 8 weeks. Subjects will also have co-administration of the
chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9
to 18 participants will be enrolled in this Phase I study.
with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging
(MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation
therapy. Full inclusion/exclusion criteria are available. History and physical examination,
and laboratory and imaging analyses will be done within 14 days prior to registration. The
three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid,
three times per week for 8 weeks. Subjects will also have co-administration of the
chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9
to 18 participants will be enrolled in this Phase I study.
Inclusion Criteria:
- Metastatic pancreatic cancer
- Glucose 6 phosphate dehydrogenase status normal
- ECOG performance status 0-2
- Normal creatinine and transaminase
- Women of child-bearing potential confirm negative pregnancy test
Exclusion Criteria:
- Concurrent chemotherapy or radiotherapy
- Significant co-morbid disorders
- Significant psychiatric symptoms
- Prior treatment with gemcitabine
- Concurrent chronic use of immunosuppressive agents (methotrexate,
cyclosporine,corticosteroids)
- Regular use of nonsteroidal anti-inflammatory agents
- Smoking more than 1 pack per day
- Excessive alcohol or drug use
- Enrollment in other experimental therapy
- Active infection
- Patients experiencing ongoing response to recent treatments
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