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Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer


Phase 1
18 Years
75 Years
Not Enrolling
Both
Metastatic Pancreatic Cancer

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Trial Information

Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.

Outcome Time Frame:

8 weeks

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

IND77486

NCT ID:

NCT00954525

Start Date:

July 2009

Completion Date:

December 2011

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

Jefferson-Myrna Brind Center of Integrative MedicinePhiladelphia, Pennsylvania  19107