Know Cancer

or
forgot password

A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts in Transformation

Thank you

Trial Information

A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure


PRIMARY OBJECTIVES:

I. Compare disease-free survival in patients with acute myeloid leukemia in second or
subsequent complete remission or in first complete remission treated with tipifarnib as
maintenance therapy vs observation alone.

SECONDARY OBJECTIVES:

I. Compare overall survival in patients treated with these regimens. II. Determine long-term
safety and toxicity of tipifarnib in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
remission status (first complete remission [CR] vs > first CR) and prior treatment for the
most current remission (consolidation therapy vs no therapy). Patients are randomized to 1
of 2 treatment arms.

ARM I: Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo observation only.

Patients are followed for up to 5 years.


Inclusion Criteria:



- Morphologically confirmed acute myeloid leukemia (AML) of 1 of the following types:

- Acute myeloblastic leukemia (M0, M1, or M2)

- Acute myelomonocytic leukemia (M4)

- Acute monocytic leukemia (M5)

- Acute erythroleukemia (M6)

- Acute megakaryocytic leukemia (M7)

- Refractory anemia with excess blasts in transformation

- AML with multilineage dysplasia

- In complete remission (CR) or molecular remission (MR) by blood counts and bone
marrow studies* AND meets 1 of the following criteria:

- In first CR after primary induction failure

- Must have received at least 2 induction chemotherapy regimens

- In second or subsequent CR

- In first remission AND > 60 years of age NOTE: *Patients with CR documented by
hematologic parameters are eligible provided current bone marrow studies confirm
CR

- Patients must meet 1 of the following criteria:

- Achieved remission within the past 60 days

- Completed induction or post-remission therapy within the past 60 days

- Achieved hematologic recovery from chemotherapy within the past 60 days

- Extramedullary disease allowed if in CR and not requiring therapy

- No acute promyelocytic leukemia (FAB M3)

- Performance status:

- ECOG 0-2

- Hematopoietic:

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

- Platelet count >= 50,000/mm^3

- Hepatic:

- Bilirubin < 2 mg/dL

- AST and ALT =< 2.5 times upper limit of normal (ULN)

- No active hepatic disease

- Renal:

- Creatinine =< 1.5 times ULN

- No active renal disease

- Cardiovascular:

- No active uncontrolled cardiac disease

- Pulmonary:

- No active uncontrolled pulmonary disease

- No known allergy to imidazole drugs* (e.g., clotrimazole, ketoconazole, miconazole,
econazole, or terconazole)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception NOTE: * Excludes fluconazole,
voriconazole, or itraconazole

- Prior autologous stem cell transplantation allowed

- Prior allogeneic bone marrow transplantation allowed provided treatment did not take
place during the current remission

- Recovered from prior chemotherapy

- Prior consolidation chemotherapy allowed

- No concurrent hepatic enzyme-inducing anticonvulsants

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Disease-free survival

Outcome Time Frame:

From randomization until relapse or death from any cause, up to 5 years

Safety Issue:

No

Principal Investigator

Selina Luger

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00535

NCT ID:

NCT00093470

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Recurrent Adult Acute Myeloid Leukemia
  • Refractory Anemia With Excess Blasts in Transformation
  • Congenital Abnormalities
  • Anemia
  • Anemia, Refractory
  • Anemia, Refractory, with Excess of Blasts
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic
  • Anemia, Aplastic

Name

Location

Albert Einstein College of Medicine Bronx, New York  10461
Johns Hopkins University Baltimore, Maryland  21205
Roswell Park Cancer Institute Buffalo, New York  14263
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
University of Washington Medical Center Seattle, Washington  98195-6043
Pennsylvania Hospital Philadelphia, Pennsylvania  19107
Boulder Community Hospital Boulder, Colorado  80301-9019
Porter Adventist Hospital Denver, Colorado  80210
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
Sky Ridge Medical Center Lone Tree, Colorado  80124
North Suburban Medical Center Thornton, Colorado  80229
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Loyola University Medical Center Maywood, Illinois  60153
CentraCare Clinic Saint Cloud, Minnesota  56303
Henry Ford Hospital Detroit, Michigan  48202
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
Rush University Medical Center Chicago, Illinois  60612-3824
Boston Medical Center Boston, Massachusetts  02118
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Puget Sound Oncology Consortium Seattle, Washington  98109
Eastern Maine Medical Center Bangor, Maine  04401
William Beaumont Hospital Royal Oak, Michigan  48073
Broward General Medical Center Fort Lauderdale, Florida  33316
Via Christi Regional Medical Center Wichita, Kansas  67214
Carolinas Medical Center Charlotte, North Carolina  28232-2861
Iowa Methodist Medical Center Des Moines, Iowa  50309
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Weill Medical College of Cornell University New York, New York  10021
Group Health Cooperative Seattle, Washington  98112
Great Falls Clinic Great Falls, Montana  59405
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
Montefiore Medical Center Bronx, New York  10467-2490
Lewistown Hospital Lewistown, Pennsylvania  17044
Mount Nittany Medical Center State College, Pennsylvania  16803
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Siouxland Regional Cancer Center Sioux City, Iowa  51101-1733
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
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
Eastern Montana Cancer Center Miles City, Montana  59301
Cottonwood Hospital Medical Center Murray, Utah  84107
Harborview Medical Center Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Central Washington Hospital Wenatchee, Washington  98801
Welch Cancer Center Sheridan, Wyoming  82801
Elkhart General Hospital Elkhart, Indiana  46515
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Memorial Hospital Carthage, Illinois  62321
Swedish Covenant Hospital Chicago, Illinois  60625
Mercy Hospital and Medical Center Chicago, Illinois  60616
Hematology and Oncology Associates Chicago, Illinois  60611
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Proctor Hospital Peoria, Illinois  61614
Perry Memorial Hospital Princeton, Illinois  61356
Valley Cancer Center Spring Valley, Illinois  61362
Genesis Medical Center - West Campus Davenport, Iowa  52804
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Wilson Medical Center Wilson, North Carolina  27893-3428
Mountainview Medical Berlin, Vermont  05602
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Eureka Hospital Eureka, Illinois  61530
Cancer Center of Kansas - Ottawa Ottawa, Kansas  66067
Graham Hospital Association Canton, Illinois  61520
Saint Joseph Medical Center Joliet, Illinois  60435
Deerpath Medical Associates Lake Forest, Illinois  60045
Pekin Hospital Pekin, Illinois  61554
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Geisinger Medical Group State College, Pennsylvania  16801
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
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Longmont United Hospital Longmont, Colorado  80501
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404
Washington Hospital Center Washington, District of Columbia  20010
Memorial Medical Center Springfield, Illinois  62781
Southeastern Medical Oncology Center Goldsboro, North Carolina  27534
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Independence Regional Health Center Independence, Missouri  64050
Northwestern University Chicago, Illinois  60611
University of Florida Gainesville, Florida  32610-0277
Case Western Reserve University Cleveland, Ohio  44106
University Of Vermont Burlington,, Vermont  05403
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado  80218
Kaiser Permanente Sacramento, California  
Wichita CCOP Wichita, Kansas  67214-3882
Montana Cancer Consortium CCOP Billings, Montana  59101
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah  84112
Providence Hospital Southfield, Michigan  48075
Decatur Memorial Hospital Decatur, Illinois  62526
Montana Cancer Specialists Missoula, Montana  59807-7877
Memorial Health University Medical Center Savannah, Georgia  31404
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
Northern Indiana Cancer Research Consortium South Bend, Indiana  
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania  17033
OSF Saint Francis Medical Center Peoria, Illinois  61637
The Medical Center of Aurora Aurora, Colorado  80012
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
Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado  81502
Saint Mary Corwin Medical Center Pueblo, Colorado  81004
Lombardi Comprehensive Cancer Center at Georgetown University Washington, District of Columbia  20057
Evanston CCOP-NorthShore University HealthSystem Evanston, Illinois  60201
Intercommunity Cancer Center Galesburg, Illinois  61401
Hopedale Medical Complex - Hospital Hopedale, Illinois  61747
Joliet Oncology-Hematology Associates Limited Joliet, Illinois  60435
Midwest Center for Hematology Oncology Joliet, Illinois  60432
North Shore Hematology Oncology Libertyville, Illinois  60048
Community Cancer Center Foundation Normal, Illinois  61761
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois  61350
Ottawa Regional Hospital and Healthcare Center Ottawa, Illinois  61350
Pekin Cancer Treatment Center Pekin, Illinois  61554
Illinois Oncology Research Association CCOP Peoria, Illinois  61615
Illinois CancerCare-Peoria Peoria, Illinois  61615
Illinois Valley Hospital Peru, Illinois  61354
Sarah Culbertson Memorial Hospital Rushville, Illinois  62681
Hematology Oncology Associates of Illinois - Skokie Skokie, Illinois  60076
Midwest Cancer Research Group Incorporated Skokie, Illinois  60077
Edward H Kaplan MD and Associates Skokie, Illinois  60076
Saint Margaret's Hospital Spring Valley, Illinois  61362
Carle Clinic-Urbana Main Urbana, Illinois  61801
Saint Joseph's Medical Center South Bend, Indiana  46617
McFarland Clinic Ames, Iowa  50010
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
Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa  50309
Mercy Medical Center-Sioux City Sioux City, Iowa  51104
Saint Luke's Regional Medical Center Sioux City, Iowa  51104
Siouxland Hematology - Oncology Associates Sioux City, Iowa  51101
Memorial Hospital of Arkansas City Arkansas City, Kansas  67005
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
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
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Ochsner Clinic CCOP New Orleans, Louisiana  70121
Kalamazoo Center for Medical Studies Kalamazoo, Michigan  49008
Lakeland Hospital St. Joseph, Michigan  49085
Medini, Eitan MD (UIA Investigator) Alexandria, Minnesota  56308
Saint Mary's Medical Center Duluth, Minnesota  55805
Miller-Dwan Hospital Duluth, Minnesota  55805
Etzell, Paul S MD (UIA Investigator) Fergus Falls, Minnesota  56537
Swenson, Wade II, MD (UIA Investigator) Fergus Falls, Minnesota  56537
Saint Cloud Hospital Saint Cloud, Minnesota  56303
Saint Luke's Cancer Institute Kansas City, Missouri  64111
Liberty Radiation Oncology Clinic Kansas City, Missouri  64116
Hematology-Oncology Centers of the Northern Rockies PC Billings, Montana  59101
Saint Vincent Healthcare Billings, Montana  59101
Deaconess Medical Center Billings, Montana  59107
Billings Clinic Billings, Montana  59107-7000
Internal Medicine of Bozeman Bozeman, Montana  59715
Saint James Community Hospital and Cancer Treatment Center Butte, Montana  59701
Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana  59405
Berdeaux, Donald MD (UIA Investigator) Great Falls, Montana  59405
Saint Peter's Community Hospital Helena, Montana  59601
Glacier Oncology PLLC Kalispell, Montana  59901
Community Medical Hospital Missoula, Montana  59801
Saint Patrick Hospital - Community Hospital Missoula, Montana  59802
Nevada Cancer Research Foundation CCOP Las Vegas, Nevada  89106
Orange Regional Medical Center Middletown, New York  10940
Wayne Memorial Hospital Goldsboro, North Carolina  27534
Samaritan North Health Center Dayton, Ohio  45415
Scranton Hematology Oncology Scranton, Pennsylvania  18510
Mercy Hospital Scranton, Pennsylvania  18501
Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania  18711
Saint Joseph Hospital Bellingham, Washington  98225
Harrison Bremerton Hematology and Oncology Bremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLC Kennewick, Washington  99336
Minor and James Medical PLLC Seattle, Washington  98104
The Polyclinic Seattle, Washington  98122
Swedish Medical Center-First Hill Seattle, Washington  98122-4307
West Virginia University Morgantown, West Virginia  26506
Sacred Heart Hospital Eau Claire, Wisconsin  54701
Oconomowoc Memorial Hospital-ProHealth Care Inc Oconomowoc, Wisconsin  53066-3896
Stony Brook University Medical Center Stony Brook, New York  11794
Memorial Healthcare System - Joe DiMaggio Children's Hospital Hollywood, Florida  33021
Northeast Georgia Cancer Care LLC Athens, Georgia  30607
Jesse Brown Veterans Affairs Medical Center Chicago, Illinois  60612
University of Tennessee - Knoxville Knoxville, Tennessee  37920
Skagit Valley Hospital Mt. Vernon, Washington  98273
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida  33136
United General Hospital Sedro-Woolley, Washington  98284
Georgia Health Sciences University Augusta, Georgia  30912
Eastern Cooperative Oncology Group Boston, Massachusetts  02215
Essentia Health Duluth Clinic CCOP Duluth, Minnesota  55805
Community Howard Regional Health Kokomo, Indiana  46904
Indiana University Health La Porte Hospital La Porte, Indiana  46350
Saint Joseph Regional Medical Center - Mishawaka Plymouth, Indiana  46544
Saint Francis Hospital - Wilmington Wilmington, Delaware  19805
Illinois Cancer Specialists-Niles Niles, Illinois  60714
Cancer Care Center of Terrebonne Center Houma, Louisiana  70360