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Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas


OBJECTIVES:

- Determine the objective response rate (confirmed, complete, and partial) in patients
with advanced soft tissue sarcomas treated with sorafenib.

- Determine the 4-month progression-free survival rate in patients treated with this
drug.

- Determine the frequency and severity of adverse events in patients treated with this
drug.

OTHER OBJECTIVES (if funding permits):

- Correlate, preliminarily, a decrease in standard uptake variable (SUV) of target
lesions by positron-emission tomography scan at 4 weeks with response in patients
treated with this drug.

- Correlate, preliminarily, the phosphorylation status of KIT, PDGFR, VEGFR, and the
raf/mek/erk pathway with response in patients treated with this drug.

- Correlate, preliminarily, the most common B-raf kinase mutation with response in
patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to histology
(leiomyosarcoma vs liposarcoma vs angiosarcoma, hemangiosarcoma, or hemangiopericytoma).

Patients receive oral sorafenib twice 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 every 8 weeks until disease
progression and then every 6 months for 2 years and annually for up to 3 years.

PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per stratum) will be accrued for this
study within 15-38 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed soft tissue sarcoma of 1 of the following histologies:

- Angiosarcoma, cutaneous or visceral

- Malignant hemangiosarcoma

- Malignant hemangiopericytoma

- Grade 3-4 leiomyosarcoma

- Grade 3-4 liposarcoma

- Must have evidence of unresectable residual disease, metastatic disease, or recurrent
disease by radiography

- Measurable disease by x-ray, scans, or physical examination

- Archived paraffin-embedded tumor sections available

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- WBC ≥ 3,000/mm^3

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

- Platelet count ≥ 100,000/mm^3

Hepatic

- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver
metastases)

- Bilirubin normal (≤ 2.5 times ULN if due to liver metastases)

- PT, PTT, and INR normal

Renal

- Creatinine normal OR

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No history of thromboembolic disease

- No uncontrolled hypertension

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Able to swallow oral medication

- 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 complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

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

- Prior adjuvant chemotherapy allowed

- No more than 1 prior chemotherapy regimen for metastatic disease

Endocrine therapy

- Not specified

Radiotherapy

- At least 28 days since prior radiotherapy and recovered

- Must have evidence of disease progression within, or measurable disease outside
of, the radiation field after completion of radiotherapy

Surgery

- At least 28 days since prior major surgery and recovered

Other

- No prior sorafenib

- No prior inhibitor of VEGFR or MAPK pathway

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent investigational agents

- No concurrent therapeutic anticoagulation

- No concurrent administration of any of the following medications:

- Rifampin

- Hypericum perforatum (St. John's wort)

- Cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the
following:

- Phenytoin

- Carbamazepine

- Phenobarbital

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Response (Confirmed, Complete and Partial)

Outcome Description:

Partial response (PR) is greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration. Stable disease does not qualify for CR, PR, Progression or Symptomatic Deterioration. Progressive disease is any one or more of the following: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Assessment inadequate is progression or symptomatic deterioration has not been documented, and one or more target measurable lesions have not been assessed or inconsistent assessment methods were used.

Outcome Time Frame:

Assessment performed every eight weeks until progression.

Safety Issue:

No

Principal Investigator

Margaret von Mehren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

NCI-2012-03063

NCT ID:

NCT00217620

Start Date:

March 2006

Completion Date:

September 2012

Related Keywords:

  • Sarcoma
  • adult angiosarcoma
  • adult leiomyosarcoma
  • adult liposarcoma
  • adult malignant hemangiopericytoma
  • recurrent adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Sarcoma

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
Medical City Dallas Hospital Dallas, Texas  75230
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
St. Rita's Medical Center Lima, Ohio  45801
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Marshfield Clinic - Indianhead Center Rice Lake, Wisconsin  54868
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
Hinsdale, Illinois  60521
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology Program Portland, Oregon  97225
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
City of Hope Comprehensive Cancer Center Duarte, California  91010
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Great Falls Clinic Great Falls, Montana  59405
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Tod Children's Hospital - Forum Health Youngstown, Ohio  44501
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland, Oregon  97227
Providence Cancer Center at Sacred Heart Medical Center Spokane, Washington  99220-2555
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - Escanaba Escanaba, Michigan  49431
CCOP - Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Southwest Medical Center Liberal, Kansas  67901
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Holland Community Hospital Holland, Michigan  49423
Hackley Hospital Muskegon, Michigan  49443
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
St. James Community Hospital Butte, Montana  59701
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
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
Olympic Hematology and Oncology Bremerton, Washington  98310
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Spectrum Health Hospital - Butterworth Campus Grand Rapids, Michigan  49503
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees, New Jersey  08043
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Front Range Cancer Specialists Fort Collins, Colorado  80528
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
Peninsula Medical Center Burlingame, California  94010
Sutter Health - Western Division Cancer Research Group Greenbrae, California  94904
Marin Cancer Institute at Marin General Hospital Greenbrae, California  94904
Kaiser Permanente Medical Office -Vandever Medical Office San Diego, California  92120
California Pacific Medical Center - California Campus San Francisco, California  94118
Sutter Solano Medical Center Vallejo, California  94589
Poudre Valley Hospital Fort Collins, Colorado  80524
Trinity Medical Center - East Moline, Illinois  61265
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Reid Hospital & Health Care Services, Incorporated Richmond, Indiana  47374
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Green Bay Oncology, Limited - Iron Mountain Iron Mountain, Michigan  49801
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Adirondack Cancer Care - Glens Falls Glens Falls, New York  12801
Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls, New York  12801
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Wilson Medical Center Wilson, North Carolina  27893-3428
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
Legacy Mount Hood Medical Center Gresham, Oregon  97030
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center Portland, Oregon  97210
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Legacy Meridian Park Hospital Tualatin, Oregon  97062
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Kingsport, Tennessee  37662
Danville Regional Medical Center Danville, Virginia  24541
Southwest Virginia Regional Cancer Center Norton, Virginia  24273
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Providence Cancer Center at Holy Family Hospital Spokane, Washington  99207
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
Green Bay Oncology, Limited at St. Vincent Hospital Green Bay, Wisconsin  54301-3526
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. Joseph Cancer Center Bellingham, Washington  98225
Oregon Health & Science University Cancer Institute Portland, Oregon  97239-3098
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
McLeod Regional Medical Center Florence, South Carolina  29501
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Billings Clinic Cancer Center Billings, Montana  59107-5100
Sletten Regional Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
AnMed Cancer Center Anderson, South Carolina  29621
Minnesota Oncology Hematology, PA at Maplewood Cancer Center Maplewood, Minnesota  55109
M.D. Anderson Cancer Center Orlando Orlando, Florida  32806