AZD2171 in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
AZD2171 in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
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 malignant mesothelioma that cannot be removed by surgery...
Date First Received: March 29, 2006
Last Updated: December 25, 2007
Verified by: National Cancer Institute (NCI), June 2007
Clinical Trial Phase: Phase 2 | Start Date: December 2005
Overall Status: Recruiting
Estimated Enrollment: 50
Brief Summary
Official Title: “Phase II Study of AZD2171 (NSC#732208) in Patients With Malignant Mesothelioma”
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 malignant mesothelioma that cannot be removed by surgery.
Study Type: Interventional
Study Design: Treatment, Open Label
Detailed Clinical Trial Description
OBJECTIVES:
Primary - Determine the objective response rate in patients with malignant pleural, peritoneal, or tunica vaginalis mesothelioma that is not amenable to curative surgery who are treated with AZD2171.
Secondary - Determine the progression-free survival of patients treated with AZD2171. - Determine the toxicity experienced by patients treated with AZD2171. - Determine median and overall survival of patients treated with AZD2171.
Tertiary - Generate preliminary data regarding potential utility of pharmacogenomic and plasma/serum biomarkers of angiogenesis as predictive or prognostic markers for future investigations of this drug in malignant mesothelioma.
OUTLINE: This is a multicenter study.
Patients receive oral ADZ2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically during study for biomarker and optional pharmacogenomic correlative studies.
After completion of study treatment, patients are followed for up to 8 weeks.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Criteria for Participation in this Clinical Trial
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignant pleural, peritoneal, or tunica vaginalis mesothelioma
- Epithelial, sarcomatoid, or mixed subtype
- International Mesothelioma Interest Group stage II-IV disease (for patients with pleural mesothelioma)
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR > 10 mm by spiral CT scan
- Pleural effusion and ascites are not considered measurable lesions
- Disease not amenable to curative surgery
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Life expectancy > 3 months
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 8 g/dL
- Platelets ≥ 100,000/mm³
- Total bilirubin normal
- AST/ALT ≤ 2.5 times upper limit of normal (ULN)
- Creatinine normal OR creatinine clearance > 60 mL/min
- Fertile patients must use effective contraception
- Not pregnant or nursing
- Negative pregnancy test
- No history of allergic reactions to compounds of similar chemical or biologic composition to AZD2171
- Mean QTc ≤ 500 msec (with Bazett's correction) by EKG
- No history of long QT syndrome
- Proteinuria ≤ 1+ on two consecutive dipsticks taken ≥ 1 week apart
- No other concurrent malignancy
- No New York Heart Association class III or IV cardiac disease
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Hypertension
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would limit study compliance
PRIOR CONCURRENT THERAPY:
- No more than 1 prior cytotoxic chemotherapy
- Prior intrapleural cytotoxic agents (including bleomycin) do not count towards prior cytotoxic chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
- No prior radiotherapy to the only site of measurable disease
- At least 4 weeks since prior radiotherapy and recovered
- At least 4 weeks since prior major surgery and recovered
- More than 30 days since prior participation in an investigational trial
- No prior treatment with a vascular endothelial growth factor (VEGF) inhibitor
- No other concurrent investigational agents
- No concurrent commercial agents for the malignancy
- No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, or pentamidine)
- No concurrent hematopoietic growth factors except epoetin alfa
- No concurrent palliative radiotherapy
- No combination antiretroviral therapy for HIV-positive patients
- No concurrent drugs or biologics with proarrhythmic potential
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor:
City of
City of Hope Medical Group
Tower Cancer Research Foundation
University of
USC/Norris Comprehensive Cancer Center and Hospital
Decatur Memorial Hospital Cancer Care Institute
Harvey Illinois 60426
Oncology Hematology Associates of Central Illinois, PC -
University of
CCOP -
Oncology Care Associates, PLLC
Penn State Cancer Institute at
Hershey
Overall Clinical Trial Officials and Contacts
Hedy L. Kindler, MD Principal Investigator University of
Additional Information
Information obtained from ClinicalTrials.gov on April 01, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00309946
Study ID Number: CDR0000463521
ClinicalTrials.gov Identifier: NCT00309946
Health Authority: Unspecified
Clinical trial summary from the National Cancer Institute's PDQ® database
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
Labels: ClinicalTrial
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