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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 CenterSeattle, Washington  98109
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
Medical City Dallas HospitalDallas, Texas  75230
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
St. Rita's Medical CenterLima, Ohio  45801
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
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
Hinsdale, Illinois  60521
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
City of Hope Comprehensive Cancer CenterDuarte, California  91010
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Great Falls ClinicGreat Falls, Montana  59405
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Tod Children's Hospital - Forum HealthYoungstown, Ohio  44501
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
St. James Community HospitalButte, Montana  59701
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
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
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Peninsula Medical CenterBurlingame, California  94010
Sutter Health - Western Division Cancer Research GroupGreenbrae, California  94904
Marin Cancer Institute at Marin General HospitalGreenbrae, California  94904
Kaiser Permanente Medical Office -Vandever Medical OfficeSan Diego, California  92120
California Pacific Medical Center - California CampusSan Francisco, California  94118
Sutter Solano Medical CenterVallejo, California  94589
Poudre Valley HospitalFort Collins, Colorado  80524
Trinity Medical Center - EastMoline, Illinois  61265
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Green Bay Oncology, Limited - Iron MountainIron Mountain, Michigan  49801
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Adirondack Cancer Care - Glens FallsGlens Falls, New York  12801
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
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
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer CenterPortland, Oregon  97210
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Danville Regional Medical CenterDanville, Virginia  24541
Southwest Virginia Regional Cancer CenterNorton, Virginia  24273
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Providence Cancer Center at Holy Family HospitalSpokane, Washington  99207
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. Joseph Cancer CenterBellingham, Washington  98225
Oregon Health & Science University Cancer InstitutePortland, Oregon  97239-3098
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
McLeod Regional Medical CenterFlorence, South Carolina  29501
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Sletten Regional Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
United States Air Force Medical Center - Wright-PattersonWright-Patterson AFB, Ohio  45433-5529
AnMed Cancer CenterAnderson, South Carolina  29621
Minnesota Oncology Hematology, PA at Maplewood Cancer CenterMaplewood, Minnesota  55109
M.D. Anderson Cancer Center OrlandoOrlando, Florida  32806