Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring stage IV esophageal cancer, recurrent esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven metastatic, locally recurrent, or unresectable squamous cell carcinoma or adenocarcinoma of the esophagus The bulk of the tumor must involve the esophagus or gastroesophageal (GE) junction (for tumors extending between the GE junction into the proximal stomach) Gastric cancers with only minor GE junction or distal esophagus involvement are not eligible Measurable or evaluable disease No prior treatment for metastatic disease No brain metastases No osseous metastases as only site of disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN Calcium no greater than 12 mg/dL Cardiovascular: No New York Heart Association class III/IV heart disease No myocardial infarction within 6 months of study No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Neurologic: No concurrent peripheral neuropathy greater than grade 1 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active serious infection or medical illness No history of hypersensitivity to drugs containing Cremophor (teniposide, cyclosporine, or vitamin K) No invasive malignancies within 5 years, except: Curatively treated basal or squamous cell carcinoma of the skin Curatively treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy within 4 weeks of study No concurrent immunotherapy Chemotherapy: No more than 1 prior chemotherapy regimen or chemotherapy/radiation therapy given in a neoadjuvant or adjuvant setting No prior chemotherapy within 4 weeks of study No concurrent chemotherapy Endocrine therapy: No prior hormonal therapy within 4 weeks of study Concurrent megestrol (Megace) allowed No other concurrent hormonal therapy Radiotherapy: No prior radiotherapy within 4 weeks of study No prior radiation to greater than 30% of bone marrow No more than 1 prior chemotherapy/radiation therapy regimen given in a neoadjuvant or adjuvant setting No concurrent radiotherapy Surgery: No prior surgery within 2 weeks of study Other: No prior parenteral antibiotics within 1 week of study
Sites / Locations
- Cancer Center of Southern Alabama
- Loma Linda University Medical Center
- Veterans Affairs Medical Center - San Francisco
- Veterans Affairs Medical Center - Washington, DC
- Florida Cancer Specialists
- Savannah Hematology Oncology Associates
- Northwest Medical Specialists, P.C.
- Michiana Hematology/Oncology P.C.
- Siouxland Hematology-Oncology
- Louisiana Oncology Associates
- Beth Israel Deaconess Medical Center
- Memorial Hospital
- Missoula Medical Oncology P.C.
- Nevada Cancer Center
- University of Medicine and Dentistry of New Jersey - MOBILE
- Albert Einstein Comprehensive Cancer Center
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Memorial Sloan-Kettering Cancer Center
- Rochester General Hospital
- New York Medical College
- Duke Comprehensive Cancer Center
- Pitt County Memorial Hospital
- Akron City Hospital
- Hollings Cancer Center
- Palmetto Hematology/Oncology Associates
- Harrington Cancer Center
- Lone Star Oncology
- Oncology Consultants
- University of Texas - MD Anderson Cancer Center
- Medical College of Wisconsin