Status:
TERMINATED
3-AP and Gemcitabine in Treating Patients With Refractory Metastatic Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Male Breast Cancer
Recurrent Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00095888
Start Date
October 1 2004
Last Update
January 16 2013
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905