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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Gemcitabine

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