Esophageal Cancer Clinical Trial
Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating patients who have advanced cancer of the esophagus.
Full Description
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.
Eligibility 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
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There are 68 Locations for this study
Scottsdale Arizona, 85259, United States
Los Angeles California, 91010, United States
Palo Alto California, 94304, United States
Stanford California, 94305, United States
Denver Colorado, 80209, United States
Wilmington Delaware, 19899, United States
Washington District of Columbia, 20307, United States
Gainesville Florida, 32608, United States
Tampa Florida, 33612, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Decatur Georgia, 30033, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Decatur Illinois, 62526, United States
Evanston Illinois, 60201, United States
Peoria Illinois, 61602, United States
Urbana Illinois, 61801, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50309, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48106, United States
Kalamazoo Michigan, 49007, United States
Duluth Minnesota, 55805, United States
Minneapolis Minnesota, 55417, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Omaha Nebraska, 68131, United States
Las Vegas Nevada, 89106, United States
East Orange New Jersey, 07018, United States
Hackensack New Jersey, 07601, United States
Hackensack New Jersey, 07601, United States
Mount Holly New Jersey, 08060, United States
New Brunswick New Jersey, 08901, United States
Perth Amboy New Jersey, 08861, United States
Red Bank New Jersey, 07701, United States
Albany New York, 12208, United States
Bronx New York, 10461, United States
Brooklyn New York, 11209, United States
New York New York, 10010, United States
New York New York, 10016, United States
Rochester New York, 14642, United States
Fargo North Dakota, 58122, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43206, United States
Toledo Ohio, 43623, United States
Tulsa Oklahoma, 74136, United States
Danville Pennsylvania, 17822, United States
Philadelphia Pennsylvania, 19102, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15240, United States
Wynnewood Pennsylvania, 19096, United States
Sioux Falls South Dakota, 57105, United States
Nashville Tennessee, 37212, United States
Nashville Tennessee, 37232, United States
Madison Wisconsin, 53705, United States
Madison Wisconsin, 53792, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
San Juan , 00927, Puerto Rico
San Juan , 00927, Puerto Rico
Pretoria , 0001, South Africa
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