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A Phase I/II Study Of Neoadjuvant Chemotherapy, Angiogenesis Inhibitor SU5416 (NSC # 696819; A TK Inhibitor Anti-Angionesises Compound), And Radiation Therapy In The Management Of High Risk, High-Grade, Soft Tissue Sarcomas Of The Extremities And Body Wall


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

A Phase I/II Study Of Neoadjuvant Chemotherapy, Angiogenesis Inhibitor SU5416 (NSC # 696819; A TK Inhibitor Anti-Angionesises Compound), And Radiation Therapy In The Management Of High Risk, High-Grade, Soft Tissue Sarcomas Of The Extremities And Body Wall


OBJECTIVES:

- Determine the maximum tolerated dose of SU5416 when administered with neoadjuvant
chemotherapy and radiotherapy and adjuvant chemotherapy in patients with high-grade
stage IIC-III soft tissue sarcoma.

- Determine the disease-free survival, local control, and overall survival in patients
treated with this regimen.

- Determine histological response in patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

- Determine the quantitative antiangiogenic effects of SU5416 in patients treated with
this regimen.

OUTLINE: This is a dose-escalation study of SU5416.

Patients receive neoadjuvant chemotherapy comprising doxorubicin, ifosfamide, and
dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients also receive filgrastim
(G-CSF) subcutaneously once daily beginning on day 5 and continuing until blood counts
recover. Patients undergo 2 courses of radiotherapy, given once daily for 11 doses per
course over days 7-20 and 28-41. Patients also receive SU5416 IV over 1 hour twice weekly
beginning on day 1 and continuing until 2 days before surgery. Patients undergo surgical
resection on day 80. Patients then receive adjuvant chemotherapy comprising doxorubicin,
ifosfamide, and dacarbazine IV continuously on days 101-103, 122-124, and 143-145. Patients
also receive SU5416 IV over 1 hour twice weekly beginning on day 101 and continuing until
the end of adjuvant chemotherapy. Patients with positive surgical margins receive additional
radiotherapy beginning 2 weeks after resection for a total of 8 doses.

Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: Approximately 68-80 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IIC-III primary or locally recurrent soft tissue
sarcoma

- Grade 2 or 3 on grade 1-3 scale OR

- Grade 3 or 4 on grade 3-4 scale

- Tumor size at least 8 cm in diameter

- Tumor located on upper extremities (including shoulder), lower extremities (including
hip), or on body wall

- No rhabdomyosarcoma, extraosseous Ewing's sarcoma, primitive neuroectodermal tumors,
osteosarcoma or chondrosarcoma, Kaposi's sarcoma or angiosarcoma of the scalp or
face, or any sarcoma of the head and neck

- No evidence of lung metastases

- Maximum of 4 chest lesion no greater than 3 mm in diameter each on preoperative chest
CT scans

- Lesions no greater than 1 cm in diameter allowed if stable for at least 1 year
and fit criteria for granulomas

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- At least 2 years

Hematopoietic:

- WBC at least 4,000/mm^3 OR

- Absolute neutrophil count at least 1,800/mm^3

- Platelet count at least 150,000/mm^3

- No prior bleeding or clotting diathesis

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- AST and ALT no greater than 1.5 times upper limit of normal

- PT and PTT less than 1.25 times normal (not on coumadin)

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- LVEF greater than 50%

- History of atherosclerotic coronary artery disease (CAD) requiring bypass surgery
allowed provided surgery occurred at least 1 year prior to study entry

- No uncompensated CAD on electrocardiogram or physical examination

- No myocardial infarction or severe or unstable angina within the past 6 months

- No New York Heart Association class II-IV heart disease

- No congestive heart failure

- No severe peripheral vascular disease

- No peripheral vascular disease with diabetes mellitus

- No deep venous or arterial thrombosis (including pulmonary embolism) within the past
3 months

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Fibrin split products less than 2 times normal

- Fibrinogen greater than 200 mg/dL

- No active uncontrolled bacterial, viral, or fungal infection

- No known hypersensitivity to E. coli-derived proteins

- No contraindications to limb-salvage surgery

- No other prior or concurrent malignancy within the past 5 years except surgically
treated carcinoma in situ of the cervix or squamous or basal cell skin cancer

- No other serious medical or psychiatric illness that would preclude study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy

Surgery:

- More than 2 weeks since minor surgery

- More than 4 weeks since major surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Burton L. Eisenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068855

NCT ID:

NCT00023738

Start Date:

August 2001

Completion Date:

October 2003

Related Keywords:

  • Sarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • stage II adult soft tissue sarcoma
  • Sarcoma

Name

Location

Akron City HospitalAkron, Ohio  44304
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Colorado Cancer CenterDenver, Colorado  80262
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Hurley Medical CenterFlint, Michigan  48503
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Bloomington HospitalBloomington, Indiana  47402
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Loyola University Medical CenterMaywood, Illinois  60153
CCOP - OchsnerNew Orleans, Louisiana  70121
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Henry Ford HospitalDetroit, Michigan  48202
Marshfield ClinicMarshfield, Wisconsin  54449
Medical College of WisconsinMilwaukee, Wisconsin  53226
Huntsville Hospital SystemHuntsville, Alabama  35801
Alabama Oncology, LLCMontgomery, Alabama  36106-2801
Radiation Oncology Associates of West AlabamaTuscallosa, Alabama  35401
Mount Diablo Medical CenterConcord, California  94524-4110
California Cancer CenterFresno, California  93720
Saint Agnes Cancer CenterFresno, California  93720
Loma Linda University Medical CenterLoma Linda, California  92354
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Cancer Care CenterPomona, California  91767
Radiation Oncology Center - SacramentoSacramento, California  95816
O'Connor HospitalSan Jose, California  95128
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
University of Florida Health Science CenterGainesville, Florida  32610-0296
Health First Holmes Regional Medical CenterMelbourne, Florida  32901
Baptist Hospital of MiamiMiami, Florida  33176-2197
Florida Radiation Oncology GroupOrange Park, Florida  32073
Gulf Coast Cancer Treatment CenterPanama City, Florida  32405-4587
Sarasota Radiation and Medical Oncology CenterSarasota, Florida  34233
Medical Center/John B. Amos Community Cancer CenterColumbus, Georgia  31902
Northwest Community HospitalArlington Heights, Illinois  60005
Northwestern Memorial HospitalChicago, Illinois  60611
Ingalls Memorial HospitalHarvey, Illinois  60426
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Central IllinoisSpringfield, Illinois  62526
St. John's Medical CenterAnderson, Indiana  46016
Community Hospitals of Indianapolis - Regional Cancer CenterIndianapolis, Indiana  46219
Ball Memorial HospitalMuncie, Indiana  47303-3499
Wendt Regional Cancer Center of Finley HospitalDubuque, Iowa  52001
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Louisville Radiation OncologyLouisville, Kentucky  40215
Merle M. Mahr Cancer CenterMadisonville, Kentucky  42431
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Tulane University School of MedicineNew Orleans, Louisiana  70112
Maine Medical CenterPortland, Maine  04102
Anne Arundel Oncology CenterAnnapolis, Maryland  21401
Greater Baltimore Medical Center and Cancer CenterBaltimore, Maryland  21204
Harbor Hospital CenterBaltimore, Maryland  21225
Cape Cod HospitalHyannis, Massachusetts  02601
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
McLaren Regional Cancer CenterFlint, Michigan  48432
Marquette General HospitalMarquette, Michigan  49855
Mallinckrodt Institute of RadiologySaint Louis, Missouri  63110
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Methodist Cancer Center - OmahaOmaha, Nebraska  68114
Elliot Regional Cancer CenterManchester, New Hampshire  03103
John F. Kennedy Medical CenterEdison, New Jersey  08818
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Community Medical CenterToms River, New Jersey  08755
St. Francis Medical CenterTrenton, New Jersey  08629
New York Methodist HospitalBrooklyn, New York  11215-3609
Champlain Valley Physicians Hospital Medical CenterPlattsburgh, New York  12901
Vassar Brothers HospitalPoughkeepsie, New York  12601
Northeast Medical CenterConcord, North Carolina  28025
Akron General Medical CenterAkron, Ohio  44302
Christ HospitalCincinnati, Ohio  45219
University Hospitals of ClevelandCleveland, Ohio  44106
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
Lehigh Valley HospitalAllentown, Pennsylvania  18103
St. Luke's Hospital Regional Cancer CenterBethlehem, Pennsylvania  18015
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Veterans Affairs Medical Center - PhiladelphiaPhiladelphia, Pennsylvania  19104
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Mercy Hospital of PittsburghPittsburgh, Pennsylvania  15219
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
Wilkes Barre General HospitalWilkes-Barre, Pennsylvania  18764
York HospitalYork, Pennsylvania  17315
Roger Williams Medical Center/BUSMProvidence, Rhode Island  02908-4735
CCOP - GreenvilleGreenville, South Carolina  29615
Jackson-Madison County General HospitalJackson, Tennessee  38301
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
Wilford Hall - 59th Medical WingLackland Air Force Base, Texas  78236-5300
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Dixie Regional Medical CenterSaint George, Utah  84770
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer CenterRichmond, Virginia  23298-0037
Virginia Mason Medical CenterSeattle, Washington  98111
Deaconess Medical CenterSpokane, Washington  99210-0248
Yakima Valley Memorial HospitalYakima, Washington  98902
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Gundersen Lutheran Medical FoundationLa Crosse, Wisconsin  54601
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Southern Wisconsin Radiotherapy CenterMadison, Wisconsin  53713
Community Memorial HospitalMenomonee Falls, Wisconsin  53051
Columbia HospitalMilwaukee, Wisconsin  53211
Southeastern Wisconsin Regional Cancer CenterRacine, Wisconsin  53405
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Comprehensive Cancer Institute of HuntsvilleHuntsville, Alabama  35801
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Radiation Medical Group, Inc.San Diego, California  92101-1492
Veterans Affairs Medical Center - MiamiMiami, Florida  33125
Bay Medical CenterPanama City, Florida  32401
Tallahassee Memorial HealthcareTallahassee, Florida  32308
Peninsula Regional Medical CenterSalisbury, Maryland  21801
MidMichigan Medical Center - MidlandMidland, Michigan  48670
William Beaumont HospitalRoyal Oak, Michigan  48073
Nebraska Health SystemOmaha, Nebraska  68105-1018
Trinitas Hospital - Jersey Street CampusElizabeth, New Jersey  07201
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
South Jersey Regional Cancer CenterMillville, New Jersey  08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Atlantic City Medical CenterPomona, New Jersey  08240
Associated Radiologists, P.A.Warren, New Jersey  07059
St. Anthony HospitalOklahoma City, Oklahoma  73101
St. John Health SystemTulsa, Oklahoma  74104
University of Utah Health Sciences CenterSalt Lake City, Utah  84132
Schiffler Cancer CenterWheeling, West Virginia  26003
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Sutter Health West Cancer Research GroupGreenbrae, California  94904
Huntington Cancer CenterPasadena, California  91105
Saint Mary's Hospital and Medical CenterGrand Junction, Colorado  81502-1628
Regional Radiation Oncology Center at RomeRome, Georgia  30165
Clarian Health Partners Inc.Indianapolis, Indiana  46206-1367
Central Baptist HospitalLexington, Kentucky  40503
William Beaumont Hospital - TroyTroy, Michigan  48098
Valley HospitalRidgewood, New Jersey  07450
Radiation Oncology Associates of AlbuquerqueAlbuquerque, New Mexico  87109
Finger Lakes Radiation Oncology CenterClifton Springs, New York  14432
Riverhill Radiation OncologyYonkers, New York  10701
Trinity Cancer Care CenterMinot, North Dakota  58701
Pocono Cancer CenterEast Stroudsburg, Pennsylvania  18301
Latter Day Saints HospitalSalt Lake City, Utah  84143
RMH Regional Cancer CenterHarrisonburg, Virginia  22801
Bon-Secours - St. Mary's HospitalRichmond, Virginia  23226
Fitzgerald Mercy HospitalDarby, Pennsylvania  19023