Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Cylene Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00780663
First received: October 27, 2008
Last updated: June 13, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Neuroendocrine Tumors
Carcinoid Tumor
Drug: Quarfloxin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Cylene Pharmaceuticals:

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. [ Time Frame: monthly for clinical benefit, every two months for tumor progression ] [ Designated as safety issue: No ]

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. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quarfloxin
Single arm study - open label.
Drug: Quarfloxin
IV Quarfloxin 240 mg/m2 daily x5 days every 21 days
Other Names:
  • CX-3543
  • quarfloxin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780663

Locations
United States, Alabama
Birmingham Hematology and Oncology
Birmingham, Alabama, United States
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Front Range Cancer Specialists
Fort Collins, Colorado, United States
United States, Florida
Ocala, Florida, United States, 34471
United States, New Mexico
Southern New Mexico Cancer Center
Las Cruces, New Mexico, United States
United States, Texas
Texas Oncology
Amarillo, Texas, United States
Texas Oncology
Dallas, Texas, United States, 75246
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, United States, 78229
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
Cylene Pharmaceuticals
  More Information

No publications provided

Responsible Party: Claire Padgett, VP Clinical Operations, Cylene Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00780663     History of Changes
Other Study ID Numbers: C3-07-003
Study First Received: October 27, 2008
Last Updated: June 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cylene Pharmaceuticals:
Neuroendocrine
Carcinoid
NET
MEN-1
Islet cell

Additional relevant MeSH terms:
Carcinoid Tumor
Carcinoma
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on August 28, 2014