search
Back to results

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

Primary Purpose

Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
triapine
gemcitabine hydrochloride
laboratory biomarker analysis
pharmacological study
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (triapine, gemcitabine hydrochloride)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0
Time to progression
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Overall survival
The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Changes in tyrosyl radical and cell-cycle arrest on buccal mucosa
Changes in R2 messenger ribonucleic acid (mRNA) on protein levels before and after treatment with triapine
MDR polymorphism on tumor tissue

Full Information

First Posted
November 9, 2004
Last Updated
January 15, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00095888
Brief Title
3-AP and Gemcitabine in Treating Patients With Refractory Metastatic Breast Cancer
Official Title
A Phase II Trial Of Gemcitabine And Triapine In Refractory Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (triapine, gemcitabine hydrochloride)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
triapine
Other Intervention Name(s)
3-AP, OCX-191
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Other Intervention Name(s)
dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Confirmed response (complete or partial response)
Description
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 Outcome Measure Information:
Title
Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0
Time Frame
Up to 3 years
Title
Time to progression
Description
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
Title
Overall survival
Description
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
Title
Changes in tyrosyl radical and cell-cycle arrest on buccal mucosa
Time Frame
Pre-infusion, 2 and 4.5 hours post-infusion
Title
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
Title
MDR polymorphism on tumor tissue
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Stewart
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs