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CompletedNCT00064051Updated Aug 2, 2013

3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer

A Phase 2 interventional study of gemcitabine hydrochloride and triapine in Pancreatic Cancer, sponsored by Vion Pharmaceuticals. Completed at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-02.

Sponsored by Vion Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer.

Read the detailed description

OBJECTIVES:

  • Determine the objective response rate (partial and complete response) in patients with unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine.
  • Determine the progression-free interval and survival of patients treated with this regimen.
  • Determine the safety and feasibility of this regimen in these patients.

OUTLINE: This is a multicenter study.

  • Stage I: Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  • Stage II: Patients receive a higher dose of 3-AP IV continuously over 24 hours on days 1, 8, and 15. Within 1 hour of completing 3-AP administration, patients receive gemcitabine IV over 30 minutes on days 2, 9, and 16. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month, every 2 months for 6 months, and then every 3 months for 18 months.

PROJECTED ACCRUAL: A total of 50-95 patients will be accrued for this study within 18-24 months.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Vion Pharmaceuticals is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed pancreatic cancer

    • Unresectable or metastatic disease

  • Measurable disease

    • Outside prior radiation ports OR within prior radiation port if evidence of disease progression after radiotherapy
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases)
  • Chronic viral hepatitis allowed

Renal

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular

  • No myocardial infarction within the past 3 months
  • No uncontrolled congestive heart failure
  • No uncontrolled coronary artery disease
  • No uncontrolled arrhythmias

Pulmonary

  • No dyspnea at rest
  • No dependence on supplemental oxygen

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation

  • No other malignancy except any of the following:

    • Carcinoma in situ of the cervix treated with cone biopsy or resection
    • Nonmetastatic basal cell or squamous cell skin cancer
    • Any stage I malignancy curatively resected more than 5 years ago
  • No active infection
  • No known or suspected glucose-6-phosphate dehydrogenase deficiency
  • No other concurrent life threatening illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed

Chemotherapy

  • No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery

  • More than 3 weeks since prior surgery and recovered

Other

  • More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease
  • No other concurrent investigational drugs
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • Druggemcitabine hydrochloride
  • Drugtriapine
06

What researchers measure

Primary outcomes

  1. Objective response rate (partial and complete response) as assessed by RECIST criteria

Secondary outcomes

  1. Progression-free and overall survival

  2. Safety and feasibility

07

Study locations

7 sites
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637-1470, United States
  • Indiana Oncology Hematology Consultants
    Indianapolis, Indiana 46202, United States
  • University of Minnesota Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Sarah Cannon Cancer Center at Centennial Medical Center
    Nashville, Tennessee 37203, United States
  • Universitair Ziekenhuis Gent
    Ghent, B-9000, Belgium
  • Christie Hospital N.H.S. Trust
    Manchester, England M20 4BX, United Kingdom
  • Royal Marsden NHS Foundation Trust - Surrey
    Sutton, England SM2 5PT, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00064051
Lead sponsor
Vion Pharmaceuticals
First posted
Jul 9, 2003
Start date
Jan 2003
Primary completion
Aug 2006
Completion
Aug 2008
Last update
Aug 2, 2013

Study contacts

Mario Sznol, MD
study chair · Vion Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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