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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
Not Enrolling
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


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

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


- 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

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

- 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

- 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:


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:


Principal Investigator

Kim Margolin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Melanoma



Louisiana State University New Orleans, Louisiana  70112-2282
University of Washington Medical Center Seattle, Washington  98195-6043
Boulder Community Hospital Boulder, Colorado  80301-9019
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Rose Medical Center Denver, Colorado  80220
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Henry Ford Hospital Detroit, Michigan  48202
South Georgia Medical Center Valdosta, Georgia  31603
Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Virginia Piper Cancer Institute Minneapolis, Minnesota  55407
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Boston Medical Center Boston, Massachusetts  02118
Via Christi Regional Medical Center Wichita, Kansas  67214
Iowa Methodist Medical Center Des Moines, Iowa  50309
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Group Health Cooperative Seattle, Washington  98112
Great Falls Clinic Great Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
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Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Holland Community Hospital Holland, Michigan  49423
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Harborview Medical Center Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Welch Cancer Center Sheridan, Wyoming  82801
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Genesis Medical Center - West Campus Davenport, Iowa  52804
Mecosta County Medical Center Big Rapids, Michigan  49307
Danville Regional Medical Center Danville, Virginia  24541
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Mary Imogene Bassett Hospital Cooperstown, New York  13326
Highland General Hospital Oakland, California  94602
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Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Hospital District Sixth of Harper County Anthony, Kansas  67003
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Northern Montana Hospital Havre, Montana  59501
Adventist Medical Center Portland, Oregon  97216
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Longmont United Hospital Longmont, Colorado  80501
Rutherford Hospital Rutherfordton, North Carolina  28139
Sutter Roseville Medical Center Roseville, California  95661
Memorial Medical Center Springfield, Illinois  62781
Metro Health Hospital Grand Rapids, Michigan  49506
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Independence Regional Health Center Independence, Missouri  64050
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Contra Costa Regional Medical Center Martinez, California  94553-3156
Larry G Strieff MD Medical Corporation Oakland, California  94609
El Camino Hospital Mountain View, California  94040
Wayne State University Detroit, Michigan  48202
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado  80218
Wichita CCOP Wichita, Kansas  67214-3882
Montana Cancer Consortium CCOP Billings, Montana  59101
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah  84112
Thomas Jefferson University Hospital Philadelphia, Pennsylvania  19131
Decatur Memorial Hospital Decatur, Illinois  62526
Montana Cancer Specialists Missoula, Montana  59807-7877
Memorial Health University Medical Center Savannah, Georgia  31404
University of Southern California Los Angeles, California  90033
University of Cincinnati Cincinnati, Ohio  45267-0502
Hays Medical Center Hays, Kansas  67601
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Eden Hospital Medical Center Castro Valley, California  94546
Valley Medical Oncology Consultants-Fremont Fremont, California  94538
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Bay Area Tumor Institution CCOP Oakland, California  94609
Tom K Lee Inc Oakland, California  94609
Valley Medical Oncology Consultants Pleasanton, California  94588
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Sutter General Hospital Sacramento, California  95816
Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo, California  94806
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Penrose-Saint Francis Healthcare Colorado Springs, Colorado  80907
Saint Anthony Central Hospital Denver, Colorado  80204
Exempla Saint Joseph Hospital Denver, Colorado  80218
Colorado Cancer Research Program CCOP Denver, Colorado  80224-2522
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Saint Mary Corwin Medical Center Pueblo, Colorado  81004
Cancer Centers of Central Florida PA Leesburg, Florida  34788
Rush - Copley Medical Center Aurora, Illinois  60504
Joliet Oncology-Hematology Associates Limited Joliet, 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 Main Urbana, Illinois  61801
Saint Anthony Memorial Health Center Michigan City, Indiana  46360
McFarland Clinic Ames, Iowa  50010
Constantinou, Costas L MD (UIA Investigator) Bettendorf, Iowa  52722
Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa  50325
Genesis Medical Center - East Campus Davenport, Iowa  52803
Iowa Oncology Research Association CCOP Des Moines, Iowa  50309
Mercy Capitol Des Moines, Iowa  50307
Mercy Medical Center - Des Moines Des Moines, Iowa  50314
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Saint Luke's Regional Medical Center Sioux City, Iowa  51104
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Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Stormont-Vail Regional Health Center Topeka, Kansas  66604
Saint Francis Hospital and Medical Center - Topeka Topeka, Kansas  66606
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Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Louisiana State University Sciences Center- Monroe Monroe, Louisiana  71210
Highland Clinic Shreveport, Louisiana  71105
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Saint Mary's Health Care Grand Rapids, Michigan  49503
Spectrum Health at Butterworth Campus Grand Rapids, Michigan  49503
Mercy Health Partners-Mercy Campus Muskegon, Michigan  49443
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Billings Clinic Billings, Montana  59107-7000
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