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Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

Primary Purpose

Neuroendocrine Tumors, Carcinoid Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Quarfloxin
Sponsored by
Cylene Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Neuroendocrine, Carcinoid, NET, MEN-1, Islet cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham Hematology and Oncology
  • Rocky Mountain Cancer Centers
  • Front Range Cancer Specialists
  • Southern New Mexico Cancer Center
  • Texas Oncology
  • Texas Oncology
  • El Paso Cancer Treatment Center
  • Cancer Care Centers of South Texas
  • UT Health Science Center
  • Tyler Cancer Center
  • Virginia Mason Medical Center
  • Northwest Cancer Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Quarfloxin

Arm Description

Single arm study - open label.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluate response rate, duration of response and progression free survival per RECIST criteria and the plasma and whole blood levels of quarfloxin.

Full Information

First Posted
October 27, 2008
Last Updated
June 13, 2011
Sponsor
Cylene Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00780663
Brief Title
Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cylene Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors, Carcinoid Tumor
Keywords
Neuroendocrine, Carcinoid, NET, MEN-1, Islet cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quarfloxin
Arm Type
Experimental
Arm Description
Single arm study - open label.
Intervention Type
Drug
Intervention Name(s)
Quarfloxin
Other Intervention Name(s)
CX-3543
Intervention Description
IV Quarfloxin 240 mg/m2 daily x5 days every 21 days
Primary Outcome Measure Information:
Title
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.
Time Frame
monthly for clinical benefit, every two months for tumor progression
Secondary Outcome Measure Information:
Title
Evaluate response rate, duration of response and progression free survival per RECIST criteria and the plasma and whole blood levels of quarfloxin.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Birmingham Hematology and Oncology
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Front Range Cancer Specialists
City
Fort Collins
State/Province
Colorado
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Southern New Mexico Cancer Center
City
Las Cruces
State/Province
New Mexico
Country
United States
Facility Name
Texas Oncology
City
Amarillo
State/Province
Texas
Country
United States
Facility Name
Texas Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
El Paso Cancer Treatment Center
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
Kerrville
State/Province
Texas
Country
United States
Facility Name
UT Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Northwest Cancer Specialists
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States

12. IPD Sharing Statement

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Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

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