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A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias

Phase 2
21 Years
Not Enrolling

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Trial Information

A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias


- Determine the response rate in pediatric patients with relapsed or refractory acute
lymphoblastic or acute myeloid leukemia treated with docetaxel.

- Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats
every 28 days for a maximum of 12 courses in the absence of disease progression or
unacceptable toxicity.

PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study within 1 year.

Inclusion Criteria


- Histologically confirmed acute lymphoblastic or acute myeloid leukemia

- M3 bone marrow relapse required

- Refractory to conventional chemotherapy

- No extramedullary disease at relapse



- 21 and under at time of initial diagnosis

Performance status:

- ECOG 0-2

Life expectancy:

- At least 2 months


- Not specified


- Bilirubin no greater than 1.5 mg/dL

- AST and ALT no greater than 1.5 times normal

- Alkaline phosphatase no greater than 2.5 times normal


- Creatinine no greater than 1.5 times normal OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- At least 7 days since prior biologic therapy and recovered

- At least 6 months since prior allogeneic stem cell transplantation

- No concurrent immunomodulating agents during first 2 courses of therapy

- No concurrent routine filgrastim (G-CSF)


- See Disease Characteristics

- At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered

- No prior paclitaxel or docetaxel

- No other concurrent chemotherapy during first 2 courses of therapy

Endocrine therapy:

- No concurrent corticosteroid therapy except dexamethasone, low-dose hydrocortisone to
treat allergic reactions, or treatment for adrenal crisis


- Recovered from prior radiotherapy

- At least 2 weeks since prior palliative local radiotherapy

- At least 6 months since prior craniospinal radiotherapy or radiotherapy to at least
50% of the pelvis

- At least 6 weeks since prior substantial bone marrow radiotherapy

- No concurrent radiotherapy


- Not specified

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to therapy

Safety Issue:


Principal Investigator

Janet Franklin, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Los Angeles


United States: Federal Government

Study ID:




Start Date:

August 2002

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • childhood acute promyelocytic leukemia (M3)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
Children's Hospital of Michigan Detroit, Michigan  48201
Hurley Medical Center Flint, Michigan  48503
Rhode Island Hospital Providence, Rhode Island  02903
Medical City Dallas Hospital Dallas, Texas  75230
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington, Connecticut  06360-2875
Baystate Regional Cancer Program at D'Amour Center for Cancer Care Springfield, Massachusetts  01199
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Avera Cancer Institute Sioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Newark Beth Israel Medical Center Newark, New Jersey  07112
New York Medical College Valhalla, New York  10595
University of Texas Medical Branch Galveston, Texas  77555-1329
Deaconess Medical Center Spokane, Washington  99210-0248
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Rush University Medical Center Chicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Long Island Cancer Center at Stony Brook University Hospital Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Scott and White Hospital Temple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Madigan Army Medical Center Tacoma, Washington  98431-5048
Sutter Cancer Center Sacramento, California  95816
Hackensack University Medical Center Hackensack, New Jersey  07601
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital of Orange County Orange, California  92668
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
St. Joseph's Hospital and Medical Center Paterson, New Jersey  07503
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
University of California Davis Cancer Center Sacramento, California  95817
Children's Hospital of Southwest Florida Fort Myers, Florida  33908
Joe DiMaggio Children's Hospital at Memorial Hollywood, Florida  33021
Nemours Children's Clinic Jacksonville, Florida  32207
Miami Children's Hospital Miami, Florida  33155-4069
Florida Hospital Cancer Institute Orlando, Florida  32804
Sacred Heart Children's Hospital Pensacola, Florida  32504
All Children's Hospital St. Petersburg, Florida  33701
Children's Memorial Hospital - Chicago Chicago, Illinois  60614
Advocate Hope Children's Hospital Oak Lawn, Illinois  60453
Saint Jude Midwest Affiliate Peoria, Illinois  61637
Wesley Medical Center Wichita, Kansas  67214
Children's Hospital of New Orleans New Orleans, Louisiana  70118
Maine Children's Cancer Program Scarborough, Maine  04074-9308
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
Floating Hospital for Children Boston, Massachusetts  02111
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
Schneider Children's Hospital New Hyde Park, New York  11042
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital System Greenville, South Carolina  29605
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
City of Hope Comprehensive Cancer Center Duarte, California  91010
UCSF Comprehensive Cancer Center San Francisco, California  94115
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Southern California Permanente Medical Group Downey, California  90242
Children's Hospital Central California Madera, California  93638-8762
Medical Center of Central Georgia Macon, Georgia  31201
Southern Illinois University School of Medicine Springfield, Illinois  62794-9658
Kosair Children's Hospital Louisville, Kentucky  40202-3830
St. Louis Children's Hospital Saint Louis, Missouri  63110
Children's Hospital of Omaha Omaha, Nebraska  68114
Sunrise Hospital and Medical Center Las Vegas, Nevada  89109-2306
Brookdale University Hospital and Medical Center Brooklyn, New York  11212
Brooklyn Hospital Center Brooklyn, New York  11201
Maimonides Medical Center Brooklyn, New York  11219
Children's Hospital Medical Center of Akron Akron, Ohio  44308
Children's Medical Center - Dayton Dayton, Ohio  45404
St. Vincent Mercy Medical Center Toledo, Ohio  43608
Toledo Children's Hospital Toledo, Ohio  43601
Palmetto Health South Carolina Cancer Center Columbia, South Carolina  29203
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Texas Tech University Health Sciences Center School of Medicine Amarillo, Texas  79106
Children's Hospital of Austin Austin, Texas  78701
Covenant Children's Hospital Lubbock, Texas  79410
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Bellin Memorial Hospital Green Bay, Wisconsin  54301
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and Clinic New Orleans, Louisiana  70112
Herbert Irving Comprehensive Cancer Center at Columbia University New York, New York  10032
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
SUNY Downstate Medical Center Brooklyn, New York  11203
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University Cleveland, Ohio  44106
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham, Alabama  35294
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach, California  90801
Children's Hospital and Research Center - Oakland Oakland, California  94609-1809
Children's Hospital and Health Center - San Diego San Diego, California  92123-4282
Santa Barbara Cottage Children's Hospital Santa Barbara, California  93105
Broward General Medical Center Cancer Center Ft. Lauderdale, Florida  33316
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer Program Miami, Florida  33176
Nemours Children's Clinic - Orlando Orlando, Florida  32806
Kaplan Cancer Center at St. Mary's Medical Center West Palm Beach, Florida  33407
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
St. Luke's Mountain States Tumor Institute - Boise Boise, Idaho  83712-6297
St. Vincent Indianapolis Hospital Indianapolis, Indiana  46260
Blank Children's Hospital Des Moines, Iowa  50309
Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans, Louisiana  70121
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore, Maryland  21215
Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
Mount Sinai Medical Center New York, New York  10029
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Mission Hospitals - Memorial Campus Asheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Tod Children's Hospital - Forum Health Youngstown, Ohio  44501
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland, Oregon  97227
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Naval Medical Center - Portsmouth Portsmouth, Virginia  23708-2197
Massey Cancer Center at Virginia Commonwealth University Richmond, Virginia  23298-0037
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston, West Virginia  25302
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown, West Virginia  26506
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
St. Mary's - Duluth Clinic Cancer Center Duluth, Minnesota  55805
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Vermont Cancer Center at University of Vermont Burlington, Vermont  05405-0075
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Group Health Central Hospital Seattle, Washington  98104
Lombardi Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles, California  90048-1865
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Lucile Packard Children's Hospital at Stanford University Medical Center Palo Alto, California  95798
Kaiser Permanente Medical Center - Santa Clara Kiely Campus Santa Clara, California  95051-5386
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus Atlanta, Georgia  30342
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Penn State Children's Hospital Hershey, Pennsylvania  17033-0850
Carilion Medical Center for Children at Roanoke Community Hospital Roanoke, Virginia  24014
Mary Bridge Children's Hospital and Health Center - Tacoma Tacoma, Washington  98405
University of South Alabama Cancer Research Institute Mobile, Alabama  36604
Kaiser Permanente Medical Center - Sacramento Sacramento, California  95825
Jackson Memorial Hospital Miami, Florida  33136
MBCCOP-Medical College of Georgia Cancer Center Augusta, Georgia  30912-4000
Dakota Cancer Institute at Innovis Health - Dakota Clinic Fargo, North Dakota  58103-4940
Children's Hospital at Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Doernbecher Children's Hospital at Oregon Health & Science University Portland, Oregon  97239-3098
East Tennessee State University Cancer Center at Johnson City Medical Center Johnson City, Tennessee  37604
Vanderbilt Children's Hospital Nashville, Tennessee  37232-6310
Methodist Cancer Center at Methodist Specialty and Transplant Hospital San Antonio, Texas  78229-3902
MBCCOP - South Texas Pediatrics San Antonio, Texas  78229-3900
Center for Cancer Prevention and Care at Scott and White Clinic Temple, Texas  76508
Cabell Huntington Hospital Huntington, West Virginia  25701
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego San Diego, California  92120
General Robert Huyser Cancer Center at David Grant Medical Center Travis Air Force Base, California  94535
Children's Hospital Cancer Center Denver, Colorado  80218
Yale Comprehensive Cancer Center at Yale University School of Medicine New Haven, Connecticut  06520-8064
St. Joseph's Children's Hospital of Tampa Tampa, Florida  33677-4227
University of Illinois at Chicago Cancer Center Chicago, Illinois  60612
Riley's Children Cancer Center at Riley Hospital for Children Indianapolis, Indiana  46202-5225
Pediatric Specialty Clinic at Eastern Maine Medical Center Bangor, Maine  04401
Walter Reed Army Medical Center Silver Spring, Maryland  20910
DeVos Children's Hospital Grand Rapids, Michigan  49503
Children's Hospitals and Clinics - Minneapolis/St. Paul Minneapolis, Minnesota  55404
Children's Hospital at Albany Medical Center Albany, New York  12208
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital Greenville, North Carolina  27858-4354
Columbus Children's Hospital Columbus, Ohio  43205-2696
Cancer Center at Baylor College of Medicine Houston, Texas  77030
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
University of Virginia Cancer Center Charlottesville, Virginia  22908
Valerie Fund Children's Center at Atlantic Health System Summit, New Jersey  07901