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A Phase 2, Multi-Center, Open Label Study Evaluating the Efficacy and Safety of Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

Phase 2
18 Years
Not Enrolling
Neuroendocrine Tumors, Carcinoid Tumor

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Trial Information

A Phase 2, Multi-Center, Open Label Study Evaluating the Efficacy and Safety of 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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

monthly for clinical benefit, every two months for tumor progression

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

March 2010

Related Keywords:

  • Neuroendocrine Tumors
  • Carcinoid Tumor
  • Neuroendocrine
  • Carcinoid
  • NET
  • MEN-1
  • Islet cell
  • Carcinoid Tumor
  • Carcinoma
  • Carcinoma, Neuroendocrine
  • Neuroendocrine Tumors



Virginia Mason Medical Center Seattle, Washington  98111
Front Range Cancer Specialists Fort Collins, Colorado  80528
Rocky Mountain Cancer Centers Thornton, Colorado  80260
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Northwest Cancer Specialists Vancouver, Washington  98664
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Texas Oncology Dallas, Texas  
Birmingham Hematology and Oncology Birmingham, Alabama  35235
El Paso Cancer Treatment Center El Paso, Texas  79915
Cancer Care Centers of South Texas San Antonio, Texas  78229
UT Health Science Center San Antonio, Texas  78245-3217
Southern New Mexico Cancer Center Las Cruces, New Mexico  88011