Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

June 13, 2011 updated by: Cylene Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Birmingham Hematology and Oncology
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
      • Fort Collins, Colorado, United States
        • Front Range Cancer Specialists
    • Florida
      • Ocala, Florida, United States, 34471
    • New Mexico
      • Las Cruces, New Mexico, United States
        • Southern New Mexico Cancer Center
    • Texas
      • Amarillo, Texas, United States
        • Texas Oncology
      • Dallas, Texas, United States, 75246
        • Texas Oncology
      • El Paso, Texas, United States
        • El Paso Cancer Treatment Center
      • Kerrville, Texas, United States
        • Cancer Care Centers of South Texas
      • San Antonio, Texas, United States, 78229
        • UT Health Science Center
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Quarfloxin
Single arm study - open label.
Drug: Quarfloxin
IV Quarfloxin 240 mg/m2 daily x5 days every 21 days
Other Names:
  • CX-3543

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
monthly for clinical benefit, every two months for tumor progression

Secondary Outcome Measures

Outcome Measure
Time Frame
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
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cylene Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 27, 2008

First Submitted That Met QC Criteria

October 27, 2008

First Posted (Estimate)

October 28, 2008

Study Record Updates

Last Update Posted (Estimate)

June 15, 2011

Last Update Submitted That Met QC Criteria

June 13, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3-07-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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