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A Phase II Trial Of Gemcitabine And Triapine In Refractory Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

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Trial Information

A Phase II Trial Of Gemcitabine And Triapine In Refractory Metastatic Breast Cancer

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

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed response (complete or partial response)

Outcome Description:

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

Outcome Time Frame:

Up to 6 months

Safety Issue:


Principal Investigator

James Stewart

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

Related Keywords:

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male



Mayo Clinic Rochester, Minnesota  55905