Know Cancer

forgot password

A Phase II Trial of Docetaxel and Carboplatin in Patients With Advanced Squamous Carcinoma of the Esophagus

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

A Phase II Trial of Docetaxel and Carboplatin in Patients With Advanced Squamous Carcinoma of the Esophagus

OBJECTIVES: I. Evaluate the objective response rate in patients with advanced squamous cell
carcinoma of the esophagus treated with carboplatin and docetaxel. II. Assess the toxicity
of this regimen in these patients. III. Assess the time to progression and overall survival
of this patient population.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, followed by carboplatin IV over
15-30 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of
disease progression or unacceptable toxicity. Patients are followed every 3 months until
year 2, every 6 months during years 2-5, and then annually thereafter until death.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study at a rate of 30
patients per year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or incurable, locally
advanced squamous cell carcinoma of the esophagus Measurable disease outside of a
previously radiated field required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin normal SGOT no greater than 2 times upper limit of
normal Renal: Creatinine normal Cardiovascular: No congestive heart failure or angina
pectoris, even if medically controlled No prior myocardial infarction within the past year
No clinically significant conduction system abnormalities, such as 2nd or 3rd degree heart
block or bundle branch block Pulmonary: Not specified Other: Not pregnant or nursing
Fertile patients must use effective contraception No active infections or medical
illnesses that are uncontrolled No second malignancy other than previously treated
nonmelanoma skin cancer or carcinoma in situ of the cervix or a prior malignancy from
which patient has been disease free for past 3 years Caloric intake greater than 1500
calories/day Fluid intake greater than 1500 mL/day

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Coenraad F. Slabber, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Pretoria Academic Hospital


United States: Federal Government

Study ID:




Start Date:

July 1999

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • squamous cell carcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Stanford University Medical Center Stanford, California  94305-5408
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Johns Hopkins Oncology Center Baltimore, Maryland  21287
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Rochester Cancer Center Rochester, New York  14642
Ireland Cancer Center Cleveland, Ohio  44106-5065
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Colorado Cancer Research Program, Inc. Denver, Colorado  80209-5031
Veterans Affairs Medical Center - Atlanta (Decatur) Decatur, Georgia  30033
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
New England Medical Center Hospital Boston, Massachusetts  02111
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
CCOP - Duluth Duluth, Minnesota  55805
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Medical College of Wisconsin Milwaukee, Wisconsin  53226
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Albany Albany, New York  12208
CCOP - Columbus Columbus, Ohio  43206
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
CCOP - Evanston Evanston, Illinois  60201
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Veterans Affairs Medical Center - New York New York, New York  10010
CCOP - Marshfield Medical Research and Education Foundation Marshfield, Wisconsin  54449
Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Pittsburgh Pittsburgh, Pennsylvania  15240
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County Mount Holly, New Jersey  08060
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Hackensack University Medical Center Hackensack, New Jersey  07601
Riverview Medical Center Red Bank, New Jersey  07701
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304
Veterans Affairs Medical Center - Cleveland Cleveland, Ohio  44106
Veterans Affairs Medical Center - Nashville Nashville, Tennessee  37212
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
CCOP - Sooner State Tulsa, Oklahoma  74136
Veterans Affairs Medical Center - Gainsville Gainesville, Florida  32608-1197
Raritan Bay Medical Center Perth Amboy, New Jersey  08861