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Pazopanib in Treating Patients With Malignant Pleural Mesothelioma
This study is ongoing, but not recruiting participants.
First Received: April 11, 2007   Last Updated: April 14, 2009   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00459862
  Purpose

RATIONALE: Pazopanib 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 the side effects and how well pazopanib works in treating patients with malignant pleural mesothelioma.


Condition Intervention Phase
Malignant Mesothelioma
Drug: pazopanib hydrochloride
Other: laboratory biomarker analysis
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of GW786034 in Patients With Malignant Pleural Mesothelioma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of patients who are progression-free at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response to treatment [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Tumor markers of angiogenesis [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: March 2007
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the effect of pazopanib hydrochloride on the proportion of patients with malignant pleural mesothelioma who are progression-free at 6 months based on the RECIST criteria.
  • Determine the clinical toxicities of this drug in this patient population.

Secondary

  • Determine the objective tumor response status in these patients as measured by the RECIST criteria or the modified RECIST criteria.
  • Determine the response rate in patients treated with this drug.
  • Determine the effect of this drug on overall survival and time to progression in these patients.
  • Assess predictive markers of activity of this drug in these patients.
  • Assess serologic markers of target inhibition by this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

Blood is collected at baseline and prior to each course of therapy and analyzed for markers of angiogenesis.

After completion of study therapy, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed malignant pleural mesothelioma

    • Measurable disease
    • No progressive disease inside or outside of any prior radiation field
  • No symptomatic, untreated, or uncontrolled CNS metastases

    • Patients with CNS metastases treated with whole brain radiation (WBRT) may be enrolled after completion of WBRT

      • Patients may begin study therapy as early as the next day after completion of WBRT

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • ANC ≥1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • WBC ≥ 3,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 50 mL/min
  • Proteinuria ≤ 1+ on 2 consecutive dipsticks taken ≥ 1 week apart
  • PT/INR/PTT ≤ 1.2 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No uncontrolled infection
  • No uncontrolled blood pressure (BP) (defined as systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg in spite of adequate anti-hypertensive therapy)
  • No condition that impairs ability to swallow and retain study drug tablets including, but not limited to, any of the following:

    • Gastrointestinal tract disease resulting in an inability to take oral medication
    • Requirement for IV alimentation
    • Prior surgical procedures affecting absorption
    • Active peptic ulcer disease
  • No other severe underlying disease that, in the judgment of the investigator, would limit study compliance
  • No other primary malignancy except for carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence

    • Patients with a history of low-grade (Gleason score ≤ 6) localized prostate cancer are eligible even if diagnosed within the past 5 years
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or other agents used in the study
  • None of the following concurrent severe and/or uncontrolled medical conditions:

    • Serious or nonhealing wound, ulcer, or bone fracture
    • Abdominal fistula, diverticulosis, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
    • Poorly controlled diabetes
    • Interstitial pneumonia
    • Extensive and symptomatic interstitial fibrosis of the lung
  • No cardiovascular illness or complication, including any of the following:

    • Any history of cerebrovascular accident within the past 6 months
    • History of myocardial infarction (prior electrocardiographic evidence of myocardial injury)
    • History of cardiac arrhythmia (prior electrocardiographic evidence of abnormal heart rhythm)
    • Admission for unstable angina
    • Cardiac angioplasty or stenting within the past 12 months
    • NYHA class III-IV heart failure

      • Asymptomatic NYHA class II heart failure allowed
    • QTc prolongation (defined as a QTc interval ≥ 500 msecs) or other significant electrocardiogram abnormalities
    • Venous thrombosis within the past 12 weeks
  • No symptomatic, untreated, or uncontrolled seizure disorder
  • No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit study compliance
  • No significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 1 prior systemic therapy for malignant pleural mesothelioma
  • No ancillary therapy considered investigational within the past 4 weeks
  • No major surgery (i.e., laparotomy) or open biopsy within the past 4 weeks*
  • No minor surgery within the past 2 weeks*
  • Prior palliative radiotherapy allowed

    • No prior palliative radiotherapy to the chest except for a maximum of 3 fractions of radiotherapy for superior vena cava syndrome
  • No concurrent therapeutic warfarin

    • Low molecular-weight heparin or prophylactic low-dose warfarin allowed
  • No other concurrent chemotherapy, immunotherapy, hormonal therapy, or radiotherapy
  • No concurrent medications that act through the CYP450 system
  • No concurrent combination antiretroviral therapy for HIV-positive patients NOTE: *Insertion of a vascular access device is not considered major or minor surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459862

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Memorial Hospital
Carthage, Illinois, United States, 62321
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Proctor Hospital
Peoria, Illinois, United States, 61614
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
United States, Indiana
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Southwest Medical Center
Liberal, Kansas, United States, 67901
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Hurley Medical Center
Flint, Michigan, United States, 48503
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. John Macomb Hospital
Warren, Michigan, United States, 48093
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota, United States, 55102
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
United Hospital
Saint Paul, Minnesota, United States, 55102
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Community Medical Center
Missoula, Montana, United States, 59801
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
St. Peter's Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Great Falls, Montana, United States, 59405
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Northern Montana Hospital
Havre, Montana, United States, 59501
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
United States, Nebraska
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
United States, North Dakota
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
United States, Ohio
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grandview Hospital
Dayton, Ohio, United States, 45405
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
CCOP - Dayton
Dayton, Ohio, United States, 45429
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
United States, Pennsylvania
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Mercy Hospital at Wilkes-Barre
Wilkes-Barre, Pennsylvania, United States, 18765
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Wisconsin
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Julian Molina, MD, PhD Mayo Clinic
Investigator: Nicholas F. Reuter, MD Coborn Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: North Central Cancer Treatment Group ( Jan C. Buckner )
Study ID Numbers: CDR0000539269, NCCTG-N0623
Study First Received: April 11, 2007
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00459862     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma
localized malignant mesothelioma
recurrent malignant mesothelioma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009