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A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) With Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Melanoma, Stage IV Melanoma

Thank you

Trial Information

A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) With Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma


PRIMARY OBJECTIVES:

I. Compare the response rate (confirmed and unconfirmed and complete and partial) in
patients with unresectable stage IV malignant melanoma treated with sorafenib in combination
with either temsirolimus or tipifarnib.

II. Compare the 4-month progression-free survival rate of patients treated with these
regimens.

III. Compare the safety and tolerability of these regimens, with an emphasis on long-term
side effects and toxic effects, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
metastatic (M) stage (M1a/b vs M1c). Patients are randomized to 1 of 2 treatment arms.

ARM I (reopened to accrual as of 8/15/2009): Patients receive oral sorafenib twice daily on
days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.

ARM II (closed to accrual as of 8/15/2009): Patients receive oral sorafenib as in arm I and
oral tipifarnib twice daily on days 1-21.

In both arms, 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 3 years.

Inclusion Criteria


Criteria:

- Histologically confirmed malignant melanoma of cutaneous origin

- Patients with unknown primary allowed

- Stage IV disease

- Measurable disease by physical examination, CT scan, MRI or plain x-ray

- Unresectable disease

- Residual or recurrent disease after prior surgery for stage IV disease allowed

- Residual tumor at the site of incomplete resection may be included only as
nonmeasurable disease

- Must have serum lactate dehydrogenase (LDH) levels measured

- Must have tissue specimens available

- Negative brain CT scan or MRI within the past 42 days

- Creatinine =< 1.5 times ULN

- Absolute neutrophil count >= 1,000/mm^3

- Platelet count >= 100,000/mm^3

- Hemoglobin >= 9.0 g/dL

- Fasting cholesterol =< 350 mg/dL (lipid-lowering agents allowed)

- Triglycerides =< 300 mg/dL (lipid-lowering agents allowed)

- No symptomatic sensory neuropathy >= grade 2

- No evidence of bleeding diathesis or coagulopathy

- No congestive heart failure

- No myocardial infarction within the past 2 months

- No New York Heart Association class III or IV heart disease

- No condition that impairs the ability to swallow pills (e.g., gastrointestinal tract
disease resulting in an inability to take oral medication, requirement for IV
alimentation, prior surgical procedure affecting absorption, or active peptic ulcer
disease)

- No known allergy to imidazoles (e.g. clotrimazole, ketoconazole, miconazole, or
econazole)

- No history of allergic reaction to compounds of similar chemical or biologic
composition as tipifarnib

- No hypertension with systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm
Hg

- Patients with well-controlled hypertension allowed

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled diabetes

- No uncontrolled diabetes

- No active uncontrolled infection

- No other severe or uncontrolled medical disease

- No psychologic or medical condition that would preclude study treatment or compliance

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, adequately treated stage I or II cancer that is in
complete remission, or carcinoma in situ of the cervix

- At least 90 days since prior adjuvant therapy, including cytotoxic agents

- At least 28 days since prior radiotherapy

- At least 28 days since prior surgery to remove the tumor

- No prior systemic therapy for stage IV melanoma

- No prior therapy with agents targeting farnesyl transferase, the MAP kinase pathway,
or vascular endothelial growth factors (VEGF) or receptors (VEFGR), including drugs
such as sorafenib, temsirolimus, or tipifarnib

- Concurrent lipid-lowering agents allowed

- Not requiring full-dose anticoagulation for recent thrombotic event

- No concurrent highly active antiretroviral therapy (HAART) in HIV-positive patients

- No concurrent use of any of the following: dilantin; carbamazepine; Phenobarbital;
rifampin; hypericum perforatum (St. John's wort); ketoconazole; itraconazole;
ritonavir; cyclosporine; phenytoin; grapefruit juice

- Bilirubin =< 1.5 times upper limit of normal (ULN)

- SGOT or SGPT =< 2.5 times ULN (5 times ULN if hepatic metastases)

- No history of brain metastases

- Zubrod performance status 0-1

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate (Complete and Partial)

Outcome Description:

Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30fi decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.

Outcome Time Frame:

Every 8 weeks until progression

Safety Issue:

No

Principal Investigator

Kim Margolin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00774

NCT ID:

NCT00281957

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Melanoma

Name

Location

Louisiana State UniversityNew Orleans, Louisiana  70112-2282
University of Washington Medical CenterSeattle, Washington  98195-6043
Boulder Community HospitalBoulder, Colorado  80301-9019
Porter Adventist HospitalDenver, Colorado  80210
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
North Suburban Medical CenterThornton, Colorado  80229
Meeker County Memorial HospitalLichfield, Minnesota  55355
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
South Georgia Medical CenterValdosta, Georgia  31603
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Boston Medical CenterBoston, Massachusetts  02118
Via Christi Regional Medical CenterWichita, Kansas  67214
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Group Health CooperativeSeattle, Washington  98112
Great Falls ClinicGreat Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Holland Community HospitalHolland, Michigan  49423
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Harborview Medical CenterSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Welch Cancer CenterSheridan, Wyoming  82801
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Genesis Medical Center - West CampusDavenport, Iowa  52804
Mecosta County Medical CenterBig Rapids, Michigan  49307
Danville Regional Medical CenterDanville, Virginia  24541
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Mary Imogene Bassett HospitalCooperstown, New York  13326
Highland General HospitalOakland, California  94602
Northeast Georgia Medical CenterGainesville, Georgia  30501
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Hospital District Sixth of Harper CountyAnthony, Kansas  67003
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Northern Montana HospitalHavre, Montana  59501
Adventist Medical CenterPortland, Oregon  97216
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Longmont United HospitalLongmont, Colorado  80501
Rutherford HospitalRutherfordton, North Carolina  28139
Sutter Roseville Medical CenterRoseville, California  95661
Memorial Medical CenterSpringfield, Illinois  62781
Metro Health HospitalGrand Rapids, Michigan  49506
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Providence Medical CenterKansas City, Kansas  66112
Independence Regional Health CenterIndependence, Missouri  64050
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Larry G Strieff MD Medical CorporationOakland, California  94609
El Camino HospitalMountain View, California  94040
Wayne State UniversityDetroit, Michigan  48202
Presbyterian - Saint Lukes Medical Center - Health OneDenver, Colorado  80218
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
Huntsman Cancer Institute/University of UtahSalt Lake City, Utah  84112
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Decatur Memorial HospitalDecatur, Illinois  62526
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Memorial Health University Medical CenterSavannah, Georgia  31404
University of Southern CaliforniaLos Angeles, California  90033
University of CincinnatiCincinnati, Ohio  45267-0502
Hays Medical CenterHays, Kansas  67601
Valley Medical Oncology Consultants-Castro ValleyCastro Valley, California  94546
Eden Hospital Medical CenterCastro Valley, California  94546
Valley Medical Oncology Consultants-FremontFremont, California  94538
Bay Area Breast Surgeons IncOakland, California  94609
Bay Area Tumor Institution CCOPOakland, California  94609
Tom K Lee IncOakland, California  94609
Valley Medical Oncology ConsultantsPleasanton, California  94588
Valley Care Health System - PleasantonPleasanton, California  94588
Sutter General HospitalSacramento, California  95816
Doctors Medical Center- JC Robinson Regional Cancer CenterSan Pablo, California  94806
The Medical Center of AuroraAurora, Colorado  80012
Penrose-Saint Francis HealthcareColorado Springs, Colorado  80907
Saint Anthony Central HospitalDenver, Colorado  80204
Exempla Saint Joseph HospitalDenver, Colorado  80218
Colorado Cancer Research Program CCOPDenver, Colorado  80224-2522
Saint Mary's Hospital and Regional Medical CenterGrand Junction, Colorado  81502
Saint Mary Corwin Medical CenterPueblo, Colorado  81004
Cancer Centers of Central Florida PALeesburg, Florida  34788
Rush - Copley Medical CenterAurora, Illinois  60504
Joliet Oncology-Hematology Associates LimitedJoliet, Illinois  60435
Stoffel, Thomas J MD (UIA Investigator)Moline, Illinois  61265
Garneau, Stewart C MD (UIA Investigator)Moline, Illinois  61265
Sharis, Christine M MD (UIA Investigator)Moline, Illinois  61265
Porubcin, Michael MD (UIA Investigator)Moline, Illinois  61265
Carle Clinic-Urbana MainUrbana, Illinois  61801
Saint Anthony Memorial Health CenterMichigan City, Indiana  46360
McFarland ClinicAmes, Iowa  50010
Constantinou, Costas L MD (UIA Investigator)Bettendorf, Iowa  52722
Medical Oncology and Hematology Associates-West Des MoinesClive, Iowa  50325
Genesis Medical Center - East CampusDavenport, Iowa  52803
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy CapitolDes Moines, Iowa  50307
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Radiation Oncology Practice Corporation SouthwestOverland Park, Kansas  66210
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Stormont-Vail Regional Health CenterTopeka, Kansas  66604
Saint Francis Hospital and Medical Center - TopekaTopeka, Kansas  66606
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Louisiana State University Sciences Center- MonroeMonroe, Louisiana  71210
Highland ClinicShreveport, Louisiana  71105
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Saint Mary's Health CareGrand Rapids, Michigan  49503
Spectrum Health at Butterworth CampusGrand Rapids, Michigan  49503
Mercy Health Partners-Mercy CampusMuskegon, Michigan  49443
Mercy Health Partners-Hackley CampusMuskegon, Michigan  49442
Southeast Missouri HospitalCape Girardeau, Missouri  63701
Radiation Oncology Practice Corporation - NorthKansas City, Missouri  64154
Radiation Oncology Practice Corporation SouthKansas City, Missouri  64114
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Community Medical HospitalMissoula, Montana  59801
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Good Samaritan HospitalKearney, Nebraska  68847
Lincoln Medical Education Foundation Cancer Resource CenterLincoln, Nebraska  68510
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Orange Regional Medical CenterMiddletown, New York  10940
Mission Hospitals IncAsheville, North Carolina  28801
Mansfield General Hospital-MedCentral Health SystemMansfield, Ohio  44903
AnMed Health HospitalAnderson, South Carolina  29621
Upstate Carolina CCOPSpartanburg, South Carolina  29303
Southwest VA Regional Cancer CenterNorton, Virginia  24273
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
Dean Hematology and Oncology ClinicMadison, Wisconsin  53717
Olathe Cancer CenterOlathe, Kansas  66061
University of Michigan University HospitalAnn Arbor, Michigan  48109
Skagit Valley HospitalMt. Vernon, Washington  98273
United General HospitalSedro-Woolley, Washington  98284
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Carle Foundation - Carle Cancer CenterUrbana, Illinois  61801
Southwest Oncology GroupSan Antonio, Texas  78245
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Bronson Battle CreekBattle Creek, Michigan  49017
Promise Regional Medical Center-HutchinsonHutchinson, Kansas  65702