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
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
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
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
Suresh Ramalingam, MD, Principal Investigator, University of Pittsburgh
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
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
- Anti-inhibitor Coagulant Complex (Drug Digest)
- Autoplex T (Drug Digest)

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