This is a Phase 2, open-label, multicenter, efficacy and safety study of quarfloxin in patients with low or intermediate grade neuroendocrine cancer. The purpose of this study is to evaluate the rate of clinical benefit response to quarfloxin treatment including the reduction in secretory symptoms of flushing and/or diarrhea or the reduction quantifiable hormones or other biochemical tumor markers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
IV Quarfloxin 240 mg/m2 daily x5 days every 21 days
Birmingham Hematology and Oncology
Birmingham, Alabama, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
Clinical benefit. Clinical benefit is defined as a reduction of secretory symptoms or reduction of quantifiable hormones or other biochemical tumor markers where concomitantly there is an absence of radiological evidence for tumor progression.
Time frame: monthly for clinical benefit, every two months for tumor progression
Evaluate response rate, duration of response and progression free survival per RECIST criteria and the plasma and whole blood levels of quarfloxin.
Time frame: One year
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Unnamed facility
Ocala, Florida, United States
Southern New Mexico Cancer Center
Las Cruces, New Mexico, United States
Texas Oncology
Amarillo, Texas, United States
Texas Oncology
Dallas, Texas, United States
El Paso Cancer Treatment Center
El Paso, Texas, United States
Cancer Care Centers of South Texas
Kerrville, Texas, United States
UT Health Science Center
San Antonio, Texas, United States
...and 3 more locations