Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

Inclusion Criteria:

• Histologically or cytologically confirmed low or intermediate grade neuroendocrine carcinoma including carcinoid and islet cell cancer. Patients with neuroendocrine tumors associated with MEN1 syndrome are eligible.
• Measureable disease by RECIST
• Unresectable or metastatic disease
• Secretory symptoms of diarrhea or flushing or both attributed to their carcinoid tumor and/or quantifiable hormones or other biochemical markers
• Males and females 18 years of age or older.
• Zero to two prior cytotoxic chemotherapy regimens.
• Patients may be receiving concomitant octreotide Sandostatin®
• Patients must have central IV access, or agree to the insertion of a central IV line.
• All previous cancer therapies, radiation, and surgery, must have been discontinued at least 21 days prior to the start of treatment.
• Acceptable liver function
• Acceptable renal function
• Acceptable hematologic status
• ECOG Performance Status ≤1.
• Anticipated survival of at least 6 months.
• Able to maintain a patient diary.
• For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment.
• Ability to understand the requirements of the study, provide written informed consent and agree to abide by the study restrictions and return to the clinic for required assessments.

Exclusion Criteria:

• Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid or small cell carcinoma.
• Pregnant or nursing women.
• Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
• Seizures not controlled by anticonvulsant therapy.
• Participation in any investigational drug study within 28 days before quarfloxin administration or currently receiving investigational therapy.
• Patients with a second malignancy requiring active treatment.
• Active symptomatic bacterial, fungal, or viral infection including active HIV or viral hepatitis.
• Prior treatment with quarfloxin.
• Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
• Patients who have exhibited allergic reactions to a similar structural compound or formulation.
• Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.