Status:
COMPLETED
Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
Lead Sponsor:
Cylene Pharmaceuticals
Conditions:
Neuroendocrine Tumors
Carcinoid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00780663
Start Date
October 1 2008
End Date
March 1 2010
Last Update
June 15 2011
Active Locations (13)
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1
Birmingham Hematology and Oncology
Birmingham, Alabama, United States
2
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
3
Front Range Cancer Specialists
Fort Collins, Colorado, United States
4
Ocala, Florida, United States, 34471