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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003326
• Other study ID #: CDR0000066278
• Secondary ID: THERADEX-B97-425
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 23, 2008
• Start date: September 1997

Study information

• Verified date: April 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• paclitaxel

Locations

Country	Name	City	State
United States	Akron City Hospital	Akron	Ohio
United States	Harrington Cancer Center	Amarillo	Texas
United States	Northwest Medical Specialists, P.C.	Arlington Heights	Illinois
United States	Lone Star Oncology	Austin	Texas
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Albert Einstein Comprehensive Cancer Center	Bronx	New York
United States	Hollings Cancer Center	Charleston	South Carolina
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Pitt County Memorial Hospital	Greenville	North Carolina
United States	Oncology Consultants	Houston	Texas
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Louisiana Oncology Associates	Lafayette	Louisiana
United States	Nevada Cancer Center	Las Vegas	Nevada
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Missoula Medical Oncology P.C.	Missoula	Montana
United States	Cancer Center of Southern Alabama	Mobile	Alabama
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	University of Medicine and Dentistry of New Jersey - MOBILE	Newark	New Jersey
United States	Rochester General Hospital	Rochester	New York
United States	Veterans Affairs Medical Center - San Francisco	San Francisco	California
United States	Savannah Hematology Oncology Associates	Savannah	Georgia
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	Michiana Hematology/Oncology P.C.	South Bend	Indiana
United States	Palmetto Hematology/Oncology Associates	Spartanburg	South Carolina
United States	New York Medical College	Valhalla	New York
United States	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia
United States	Memorial Hospital	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Theradex

Country where clinical trial is conducted

United States,