Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780663
• Other study ID #: C3-07-003
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2008
• Last updated: June 13, 2011
• Start date: October 2008
• Est. completion date: March 2010

Study information

• Verified date: June 2011
• Source: Cylene Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma, Neuroendocrine
• Neuroendocrine Tumors

Intervention

Drug:
• Quarfloxin
IV Quarfloxin 240 mg/m2 daily x5 days every 21 days

Locations

Country	Name	City	State
United States	Texas Oncology	Amarillo	Texas
United States	Birmingham Hematology and Oncology	Birmingham	Alabama
United States	Texas Oncology	Dallas	Texas
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	El Paso Cancer Treatment Center	El Paso	Texas
United States	Front Range Cancer Specialists	Fort Collins	Colorado
United States	Cancer Care Centers of South Texas	Kerrville	Texas
United States	Southern New Mexico Cancer Center	Las Cruces	New Mexico
United States	UT Health Science Center	San Antonio	Texas
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Tyler Cancer Center	Tyler	Texas
United States	Northwest Cancer Specialists	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Cylene Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluate response rate, duration of response and progression free survival per RECIST criteria and the plasma and whole blood levels of quarfloxin.		One year	No