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AZD2171 in Treating Patients With Recurrent Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: California Cancer Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00245063
  Purpose

RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well AZD2171 works in treating patients with recurrent small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cediranib maleate
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Cediranib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of AZD 2171 in Patients With Recurrent Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: September 2005
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with recurrent small cell lung cancer treated with AZD2171.

Secondary

  • Determine overall survival and time to progression in patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral AZD2171 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer

    • Recurrent disease after 1 prior platinum-based chemotherapy regimen
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No known brain metastases

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2 OR
  • Karnofsky 50-100%

Life expectancy

  • More than 12 weeks

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL

Hepatic

  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min
  • No proteinuria > +1 on 2 consecutive dipsticks taken no less than 1 week apart

Cardiovascular

  • QTc ≤ 470 msec by EKG (with Bazett's correction)
  • No history of familial long QT syndrome
  • No uncontrolled hypertension
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No uncontrolled cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double barrier-method contraception ≥ 1 week before, during, and ≥ 2 weeks after completion of study treatment
  • Able to take oral medications on a regular basis
  • No other uncontrolled illness
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No more than 1 prior chemotherapy regimen

Radiotherapy

  • More than 4 weeks since prior radiotherapy

Surgery

  • More than 4 weeks since prior major surgery

Other

  • Recovered from prior therapy
  • More than 30 days since prior participation in an investigational trial
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245063

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
Contra Costa Regional Medical Center
Martinez, California, United States, 94553
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615-7828
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46885-5099
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, United States, 46601
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
California Cancer Consortium
Investigators
Principal Investigator: Suresh Ramalingam, MD UPMC Cancer Centers
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Ramalingam SS, Mack PC, Vokes EE, et al.: Cediranib (AZD2171) for the treatment of recurrent small cell lung cancer (SCLC): A California Consortium phase II study (NCI # 7097). [Abstract] J Clin Oncol 26 (Suppl 15): A-8078, 2008.

Study ID Numbers: CDR0000448627, CCC-PHII-64, NCI-7097
Study First Received: October 25, 2005
Last Updated: December 6, 2008
ClinicalTrials.gov Identifier: NCT00245063  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 16, 2009