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A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Patients With Advanced Esophageal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Patients With Advanced Esophageal Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David Paul Kelsen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066278

NCT ID:

NCT00003326

Start Date:

September 1997

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • squamous cell carcinoma of the esophagus
  • adenocarcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Medical College of WisconsinMilwaukee, Wisconsin  53226
Loma Linda University Medical CenterLoma Linda, California  92354
New York Medical CollegeValhalla, New York  10595
Harrington Cancer CenterAmarillo, Texas  79106
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Michiana Hematology/Oncology P.C.South Bend, Indiana  46617
Palmetto Hematology/Oncology AssociatesSpartanburg, South Carolina  29303
Cancer Center of Southern AlabamaMobile, Alabama  36607
Florida Cancer SpecialistsFort Myers, Florida  33901
Savannah Hematology Oncology AssociatesSavannah, Georgia  31405
Northwest Medical Specialists, P.C.Arlington Heights, Illinois  60004
Louisiana Oncology AssociatesLafayette, Louisiana  70506
Memorial HospitalWorcester, Massachusetts  01605
Missoula Medical Oncology P.C.Missoula, Montana  59802
Nevada Cancer CenterLas Vegas, Nevada  89109
University of Medicine and Dentistry of New Jersey - MOBILENewark, New Jersey  07103
Rochester General HospitalRochester, New York  14621
Pitt County Memorial HospitalGreenville, North Carolina  27835-6028
Hollings Cancer CenterCharleston, South Carolina  29403
Lone Star OncologyAustin, Texas  78759
Oncology ConsultantsHouston, Texas  77024