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A Phase II Trial of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Mesothelioma

Thank you

Trial Information

A Phase II Trial of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma


OBJECTIVES:

Primary

- Determine the objective confirmed, complete, and partial response rates in patients
with unresectable malignant pleural mesothelioma treated with AZD2171.

Secondary

- Determine the clinical benefit, in terms of objective response and stable disease
rates, in patients treated with this drug.

- Determine the 1-year median overall survival and progression-free survival in patients
treated with this drug.

- Determine the frequency and severity of toxic effects in patients treated with this
drug.

- Correlate, preliminarily, pre- and post-treatment plasma vascular endothelial growth
factor and soluble vascular cell adhesion molecule with clinical outcomes in patients
treated with this drug.

- Correlate, preliminarily, circulating endothelial cells with clinical outcomes in
patients treated with this drug.

- Correlate variants of genes in the pathway targeted by this drug and variants of genes
involved in the development of hypertension with the antiangiogenic property of this
drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years
from study entry.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed epithelial, sarcomatous, or biphasic malignant pleural
mesothelioma

- Unresectable disease

- Residual disease after prior cytoreductive surgery allowed

- Measurable disease by CT scan or MRI

- Prior treatment with platinum-based chemotherapy required

- No known CNS metastasis

PATIENT CHARACTERISTICS:

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- AST or ALT ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin normal

Renal

- Creatinine ≤ 1.5 times ULN OR

- Creatinine clearance ≥ 50 mL/min

- Proteinuria ≤ 1+ by 2 consecutive dipstick tests taken ≥ 1 week apart

Cardiovascular

- No history of familial long QT syndrome

- Mean QTc ≤ 470 msec

- Systolic BP ≤ 150 mm Hg AND diastolic BP ≤ 100 mm Hg

- Must have New York Heart Association class I or II disease

- Class II must be controlled with treatment

Gastrointestinal

- Able to swallow and/or receive enteral medications via gastrostomy feeding tube

- Not requiring IV alimentation

- No active peptic ulcer

- No intractable nausea or vomiting

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in remission

- No history of hypersensitivity reaction to compounds of similar chemical or
biological composition to the study drug

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Prior monoclonal antibody therapy targeting vascular endothelial growth factor
(VEGF), VEGF receptor 1 (VEGFR1) or VEGF receptor 2 (VEGFR2) allowed

- No other prior immunotherapy or biologic therapy

- No prior thymidine kinase inhibitor against VEGFR1 or VEGFR2

- No concurrent drugs or biologics with proarrythmic potential

Chemotherapy

- See Disease Characteristics

- No more than 1 prior chemotherapy regimen

- At least 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin) and
recovered

Radiotherapy

- At least 21 days since prior radiotherapy and recovered

Surgery

- See Disease Characteristics

- At least 28 days since prior major surgery (e.g., thoracotomy or laparotomy) and
recovered

- No prior surgery that would affect absorption

Other

- Stable antihypertensive therapy allowed provided blood pressure (BP) parameters are
met

- Concurrent enrollment on SWOG-S9925 allowed

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (complete response and partial response)

Outcome Time Frame:

3 years or until death

Safety Issue:

No

Principal Investigator

Linda Garland, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Federal Government

Study ID:

CDR0000446178

NCT ID:

NCT00243074

Start Date:

November 2005

Completion Date:

April 2010

Related Keywords:

  • Malignant Mesothelioma
  • epithelial mesothelioma
  • sarcomatous mesothelioma
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • Mesothelioma

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Hurley Medical CenterFlint, Michigan  48503
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
LDS HospitalSalt Lake City, Utah  84143
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
University of California Davis Cancer CenterSacramento, California  95817
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Broward General Medical Center Cancer CenterFt. Lauderdale, Florida  33316
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Genesis Medical Center - West CampusDavenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Cleveland Clinic - WoosterWooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Danville Regional Medical CenterDanville, Virginia  24541
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Northeast Georgia Medical CenterGainesville, Georgia  30501
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Southwest Virginia Regional Cancer Center at Wellmonth HealthNorton, Virginia  24273
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Charles Medical Center - BendBend, Oregon  97701
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401
Boston University Cancer Research CenterBoston, Massachusetts  02118
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Caritas St. Elizabeth's Medical CenterBrighton, Massachusetts  02135-2997