Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT00954525
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine and Erlotinib — DRUG
    Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)
  • Intravenous Vitamin C — DIETARY_SUPPLEMENT
    50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.

Study Details

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.

Key Dates

First listed
Aug 7, 2009
Start date
Jul 31, 2009
Status verified
May 2025
Primary completion
Dec 31, 2011
Completion
Dec 31, 2011

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intravenous Vitamin C

Primary Outcome Measure

Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality. [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Jefferson-Myrna Brind Center of Integrative MedicinePhiladelphiaPennsylvania19107-

Find similar trials in Philadelphia, PA

By research site
Jefferson-Myrna Brind Center of Integrative Medicine· Philadelphia, PA

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