Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Malignant Mesothelioma

Thank you

Trial Information

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



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


- 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

- 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


- Histologically confirmed epithelial, sarcomatous, or biphasic malignant pleural

- 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


Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- WBC ≥ 3,000/mm^3

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

- Platelet count ≥ 100,000/mm^3


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

- Bilirubin normal


- Creatinine ≤ 1.5 times ULN OR

- Creatinine clearance ≥ 50 mL/min

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


- 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


- 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


- 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


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


- See Disease Characteristics

- No more than 1 prior chemotherapy regimen

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


- At least 21 days since prior radiotherapy and recovered


- See Disease Characteristics

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

- No prior surgery that would affect absorption


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

- Concurrent enrollment on SWOG-S9925 allowed

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


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:


Principal Investigator

Linda Garland, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona


United States: Federal Government

Study ID:




Start Date:

November 2005

Completion Date:

April 2010

Related Keywords:

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



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
Hurley Medical Center Flint, Michigan  48503
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Greenville Greenville, South Carolina  29615
LDS Hospital Salt Lake City, Utah  84143
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
University of California Davis Cancer Center Sacramento, California  95817
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Broward General Medical Center Cancer Center Ft. Lauderdale, Florida  33316
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Cottonwood Hospital Medical Center Murray, Utah  84107
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Genesis Medical Center - West Campus Davenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Community Oncology Group at Cleveland Clinic Cancer Center Independence, Ohio  44131
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Cleveland Clinic - Wooster Wooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Kingsport, Tennessee  37662
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Danville Regional Medical Center Danville, Virginia  24541
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Northeast Georgia Medical Center Gainesville, Georgia  30501
Reid Hospital & Health Care Services Richmond, Indiana  47374
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
Southwest Virginia Regional Cancer Center at Wellmonth Health Norton, Virginia  24273
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
St. Charles Medical Center - Bend Bend, Oregon  97701
Roper St. Francis Cancer Center at Roper Hospital Charleston, South Carolina  29401
Boston University Cancer Research Center Boston, Massachusetts  02118
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Caritas St. Elizabeth's Medical Center Brighton, Massachusetts  02135-2997