Esophageal Cancer Clinical Trial

Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus

Summary

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.

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Full Description

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.

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.

View Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT00003326

Recruitment Status:

Unknown status

Sponsor:

Theradex

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There are 30 Locations for this study

See Locations Near You

Cancer Center of Southern Alabama
Mobile Alabama, 36607, United States
Loma Linda University Medical Center
Loma Linda California, 92354, United States
Veterans Affairs Medical Center - San Francisco
San Francisco California, 94121, United States
Veterans Affairs Medical Center - Washington, DC
Washington District of Columbia, 20422, United States
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Savannah Hematology Oncology Associates
Savannah Georgia, 31405, United States
Northwest Medical Specialists, P.C.
Arlington Heights Illinois, 60004, United States
Michiana Hematology/Oncology P.C.
South Bend Indiana, 46617, United States
Siouxland Hematology-Oncology
Sioux City Iowa, 51101, United States
Louisiana Oncology Associates
Lafayette Louisiana, 70506, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Memorial Hospital
Worcester Massachusetts, 01605, United States
Missoula Medical Oncology P.C.
Missoula Montana, 59802, United States
Nevada Cancer Center
Las Vegas Nevada, 89109, United States
University of Medicine and Dentistry of New Jersey - MOBILE
Newark New Jersey, 07103, United States
Albert Einstein Comprehensive Cancer Center
Bronx New York, 10461, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Rochester General Hospital
Rochester New York, 14621, United States
New York Medical College
Valhalla New York, 10595, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Pitt County Memorial Hospital
Greenville North Carolina, 27835, United States
Akron City Hospital
Akron Ohio, 44309, United States
Hollings Cancer Center
Charleston South Carolina, 29403, United States
Palmetto Hematology/Oncology Associates
Spartanburg South Carolina, 29303, United States
Harrington Cancer Center
Amarillo Texas, 79106, United States
Lone Star Oncology
Austin Texas, 78759, United States
Oncology Consultants
Houston Texas, 77024, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT00003326

Recruitment Status:

Unknown status

Sponsor:


Theradex

How clear is this clinincal trial information?

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