NCT01049880

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 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

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

3.2 years

First QC Date

January 14, 2010

Last Update Submit

April 19, 2017

Conditions

Pancreatic Neoplasms

Keywords

Ascorbic AcidGemcitabine

Outcome Measures

Primary Outcomes (1)

  • Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine)

    weekly

Secondary Outcomes (2)

  • Plasma ascorbate level (targeted to 350 to 400 mg/dL)

    Weekly

  • Survival

    Ongoing

Study Arms (1)

Ascorbate

EXPERIMENTAL
Drug: Gemcitabine with escalating ascorbic acid

Interventions

Gemcitabine with escalating ascorbic acidDRUG

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.

Also known as: Gemzar, Ascor L 500
Ascorbate

Eligibility Criteria

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

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • Welsh JL, Wagner BA, van't Erve TJ, Zehr PS, Berg DJ, Halfdanarson TR, Yee NS, Bodeker KL, Du J, Roberts LJ 2nd, Drisko J, Levine M, Buettner GR, Cullen JJ. Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancreatic cancer (PACMAN): results from a phase I clinical trial. Cancer Chemother Pharmacol. 2013 Mar;71(3):765-75. doi: 10.1007/s00280-013-2070-8. Epub 2013 Feb 5.

    PMID: 23381814RESULT

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Joseph J Cullen, M.D.

    University of Iowa

    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 INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 15, 2010

Study Start

December 1, 2009

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations

US(1)