A Phase II Trial of Docetaxel and Carboplatin in Patients With Advanced Squamous Carcinoma of the Esophagus
carboplatin
+ docetaxel
Carcinoma+12
+ Carcinoma, Squamous Cell
+ Digestive System Diseases
Treatment Study
Summary
Study start date: September 3, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 74 locations
CCOP - Scottsdale Oncology Program
Scottsdale, United StatesOpen CCOP - Scottsdale Oncology Program in Google MapsCancer Center and Beckman Research Institute, City of Hope
Los Angeles, United StatesVeterans Affairs Medical Center - Palo Alto
Palo Alto, United StatesStanford University Medical Center
Stanford, United States