Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
A Phase 2, Multi-Center, Open Label Study Evaluating the Efficacy and Safety of Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
1 other identifier
interventional
25
1 country
13
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2008
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 27, 2008
CompletedFirst Posted
Study publicly available on registry
October 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJune 15, 2011
June 1, 2011
1.4 years
October 27, 2008
June 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
monthly for clinical benefit, every two months for tumor progression
Secondary Outcomes (1)
Evaluate response rate, duration of response and progression free survival per RECIST criteria and the plasma and whole blood levels of quarfloxin.
One year
Study Arms (1)
Quarfloxin
EXPERIMENTALSingle arm study - open label.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +2 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Birmingham Hematology and Oncology
Birmingham, Alabama, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
Unknown Facility
Ocala, Florida, 34471, United States
Southern New Mexico Cancer Center
Las Cruces, New Mexico, United States
Texas Oncology
Amarillo, Texas, United States
Texas Oncology
Dallas, Texas, 75246, 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, 78229, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Northwest Cancer Specialists
Vancouver, Washington, 98684, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 27, 2008
First Posted
October 28, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
June 15, 2011
Record last verified: 2011-06