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AZD2171 in Treating Patients With Recurrent Small Cell Lung Cancer - Article


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Anti-inhibitor Coagulant Complex

Autoplex T; FEIBA VH Immuno 




Clinical Trial: AZD2171 in Treating Patients With Recurrent Small Cell Lung Cancer

This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) October 2005

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
Recurrent Small Cell Lung Cancer
 Drug: AZD2171
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: enzyme inhibitor therapy
 Procedure: growth factor antagonist therapy
 Procedure: protein tyrosine kinase inhibitor therapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapies;   Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of AZD2171 in Patients With Recurrent Small Cell Lung Cancer

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

OBJECTIVES:

Primary

Secondary

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 above,  Genders Eligible for Study:  Both
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 60-100%

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 history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug
  • 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00245063


Study chairs or principal investigators

Suresh Ramalingam, MD,  Principal Investigator,  University of Pittsburgh   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000448627; CCC-PHII-64; NCI-7097
Last Updated:  December 8, 2005
Record first received:  October 25, 2005
ClinicalTrials.gov Identifier:  NCT00245063
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10

Resources



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November 27, 2009



Page Updated: June 1, 2005
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