NCT00954525

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 2, 2025

Status Verified

May 1, 2025

Enrollment Period

2.4 years

First QC Date

August 4, 2009

Last Update Submit

May 1, 2025

Conditions

Metastatic Pancreatic Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (1)

  • Progression-free survival

    8 weeks

Study Arms (1)

Intravenous Vitamin C

EXPERIMENTAL
Drug: Gemcitabine and ErlotinibDietary Supplement: Intravenous Vitamin C

Interventions

Gemcitabine and ErlotinibDRUG

Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)

Intravenous Vitamin C
Intravenous Vitamin CDIETARY_SUPPLEMENT

50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.

Intravenous Vitamin C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jefferson-Myrna Brind Center of Integrative Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Monti DA, Mitchell E, Bazzan AJ, Littman S, Zabrecky G, Yeo CJ, Pillai MV, Newberg AB, Deshmukh S, Levine M. Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One. 2012;7(1):e29794. doi: 10.1371/journal.pone.0029794. Epub 2012 Jan 17.

    PMID: 22272248DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineErlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Daniel Monti, MD, MBA

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 7, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 2, 2025

Record last verified: 2025-05

Locations

US(1)