NCT00095888

Brief Summary

Phase II trial to study the effectiveness of combining 3-AP with gemcitabine in treating patients who have refractory metastatic breast cancer. Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining 3-AP with gemcitabine may kill more tumor cells

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

1.7 years

First QC Date

November 9, 2004

Last Update Submit

January 15, 2013

Conditions

Male Breast CancerRecurrent Breast CancerStage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Confirmed response (complete or partial response)

    Ninety five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

    Up to 6 months

Secondary Outcomes (6)

  • Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0

    Up to 3 years

  • Time to progression

    Time from registration to the time of progression, assessed up to 3 years

  • Overall survival

    Time from registration to death due to any cause, assessed up to 3 years

  • Changes in tyrosyl radical and cell-cycle arrest on buccal mucosa

    Pre-infusion, 2 and 4.5 hours post-infusion

  • Changes in R2 messenger ribonucleic acid (mRNA) on protein levels before and after treatment with triapine

    Pre-infusion, 2 and 4.5 hours post-infusion

  • +1 more secondary outcomes

Study Arms (1)

Treatment (triapine, gemcitabine hydrochloride)

EXPERIMENTAL

Patients receive 3-AP (Triapine®) IV over 2 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: triapineDrug: gemcitabine hydrochlorideOther: laboratory biomarker analysisOther: pharmacological study

Interventions

triapineDRUG

Given IV

Also known as: 3-AP, OCX-191
Treatment (triapine, gemcitabine hydrochloride)
gemcitabine hydrochlorideDRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Treatment (triapine, gemcitabine hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (triapine, gemcitabine hydrochloride)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (triapine, gemcitabine hydrochloride)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed breast cancer
  • Refractory metastatic disease
  • Measurable disease
  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Must have received 1, and only 1, prior chemotherapy regimen for metastatic disease
  • Patients overexpressing HER2/neu antigen must have received a prior trastuzumab (Herceptin®)-containing regimen
  • No known brain metastases
  • Hormone receptor status:
  • Not specified
  • Male or female
  • Performance status - ECOG 0-2
  • At least 12 weeks
  • WBC ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, MaleBreast Neoplasms

Interventions

3-aminopyridine-2-carboxaldehyde thiosemicarbazoneGemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • James Stewart

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 9, 2004

Study Start

October 1, 2004

Primary Completion

June 1, 2006

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)