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TerminatedNCT00095888Updated Jan 16, 2013

3-AP and Gemcitabine in Treating Patients With Refractory Metastatic Breast Cancer

A Phase 2 interventional study of triapine and gemcitabine hydrochloride in Male Breast Cancer, Recurrent Breast Cancer and Stage IV Breast Cancer, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-16.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Why this study was terminated
Administratively complete.
Phase
Phase 2
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

OBJECTIVES: Primary I. Determine antitumor activity of 3-AP (Triapine®) and gemcitabine by measuring tumor size in patients with refractory metastatic breast cancer.

Secondary I. Determine the safety and tolerability of this regimen in these patients. II. Determine the time to disease progression in patients treated with this regimen.

III. Determine the effect of multidrug resistance polymorphisms on pharmacokinetics and toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

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.

Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after registration.

PROJECTED ACCRUAL: A total of 30-75 patients will be accrued for this study within 24 months.

02

Conditions studied

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 68 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

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

Inclusion Criteria:

  • 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
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal
  • Creatinine clearance ≥ 60 mL/min
  • No uncontrolled congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No severe pulmonary disease requiring oxygen
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • No other uncontrolled illness
  • No active or ongoing infection
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to 3-AP (Triapine®) or other study agents
  • No psychiatric illness or social situation that would preclude study compliance
  • No other malignancy within the past 5 years
  • See Disease Characteristics
  • No concurrent immunotherapy
  • No concurrent routine colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No prior gemcitabine for metastatic disease
  • No other concurrent chemotherapy
  • More than 4 weeks since prior hormonal therapy
  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy
  • Recovered from prior therapy
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational therapy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Treatment (triapine, gemcitabine hydrochloride)

    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: triapine · Drug: gemcitabine hydrochloride · Other: laboratory biomarker analysis · Other: pharmacological study

Interventions

  • Drugtriapine

    Given IV

    Also known as: 3-AP, OCX-191

  • Druggemcitabine hydrochloride

    Given IV

    Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

  • Otherlaboratory biomarker analysis

    Correlative studies

  • Otherpharmacological study

    Correlative studies

    Also known as: pharmacological studies

06

What researchers measure

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.

    Time frame: Up to 6 months

Secondary outcomes

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

    Time frame: Up to 3 years

  2. Time to progression

    The distribution of time to progression will be estimated using the method of Kaplan-Meier.

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

  3. Overall survival

    The distribution of overall survival will be estimated using the method of Kaplan-Meier.

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

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

    Time frame: Pre-infusion, 2 and 4.5 hours post-infusion

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

    Time frame: Pre-infusion, 2 and 4.5 hours post-infusion

  6. MDR polymorphism on tumor tissue

    Time frame: Baseline

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00095888
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 9, 2004
Start date
Oct 2004
Primary completion
Jun 2006
Last update
Jan 16, 2013

Study contacts

James Stewart
principal investigator · Mayo Clinic
View the source record on ClinicalTrials.gov ↗

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