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Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus Clinical research trials and Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus. Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus clinical trial. Participants typically obtain the most effective healthcare available for their Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus  Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus
Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus
For Condition: Quality of Life,recurrent esophageal cancer,squamous cell carcinoma of the esophagus,stage 4 esophageal cancer,Adenocarcinoma of the Esophagus
Status: No longer recruiting
Sponsor(s): Theradex ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with metastatic, recurrent, or unresectable cancer of the esophagus.
Details: OBJECTIVES: I. Determine the objective response rate of paclitaxel administered as a weekly one hour infusion in patients with metastatic, locally recurrent, or unresectable squamous cell carcinoma and adenocarcinoma of the esophagus. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival and quality of life of these patients. PROTOCOL OUTLINE: This is an open label, multicenter study. Patients receive intravenous paclitaxel over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until disease progression or unacceptable toxic effects is observed. Patient response is assessed every 2 courses during the first year and then every 3 months in subsequent years. Quality of life is assessed prior to treatment, prior to each course for 6 courses, then every 2 courses. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidKelsen, Study Chair, Theradex
New York Medical College
Valhalla, New York, 10595
United States
Savannah Hematology Oncology Associates
Savannah, Georgia, 31405
United States
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
Missoula Medical Oncology P.C.
Missoula, Montana, 59802
United States
Pitt County Memorial Hospital
Greenville, North Carolina, 27835-6028
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Rochester General Hospital
Rochester, New York, 14621
United States
Oncology Consultants
Houston, Texas, 77024
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Medicine and Dentistry of New Jersey - MOBILE
Newark, New Jersey, 07103
United States
Cancer Center of Southern Alabama
Mobile, Alabama, 36607
United States
Hollings Cancer Center
Charleston, South Carolina, 29403
United States
Akron City Hospital
Akron, Ohio, 44309
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Memorial Hospital
Worcester, Massachusetts, 01605
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Harrington Cancer Center
Amarillo, Texas, 79106
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Northwest Medical Specialists, P.C.
Arlington Heights, Illinois, 60004
United States
Palmetto Hematology/Oncology Associates
Spartanburg, South Carolina, 29303
United States
Lone Star Oncology
Austin, Texas, 78759
United States
Nevada Cancer Center
Las Vegas, Nevada, 89109
United States
Additional Information:
Study ID Numbers: CDR0000066278; THERADEX-B97-4250,NCI-V98-1414,BMS-TAX/MEN.04,MSKCC-98018,NYU-9801
Study Start Date: September 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003326
Other Recurrent Esophageal Cancer Studies:
1. Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus
2. Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
3. Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus
4. Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
5. Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Related Studies:
Other recurrent esophageal cancer Clinical Trials
Other Georgia Clinical Trials
Other Savannah Clinical Trials
Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus
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