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

Sponsor

Theradex (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00003326

Collaborator

(none)

100

Enrollment

Locations

3.3

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: paclitaxel	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 1997

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center of Southern Alabama	Mobile	Alabama	United States	36607
2	Loma Linda University Medical Center	Loma Linda	California	United States	92354
3	Veterans Affairs Medical Center - San Francisco	San Francisco	California	United States	94121
4	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia	United States	20422
5	Florida Cancer Specialists	Fort Myers	Florida	United States	33901
6	Savannah Hematology Oncology Associates	Savannah	Georgia	United States	31405
7	Northwest Medical Specialists, P.C.	Arlington Heights	Illinois	United States	60004
8	Michiana Hematology/Oncology P.C.	South Bend	Indiana	United States	46617
9	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
10	Louisiana Oncology Associates	Lafayette	Louisiana	United States	70506
11	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
12	Memorial Hospital	Worcester	Massachusetts	United States	01605
13	Missoula Medical Oncology P.C.	Missoula	Montana	United States	59802
14	Nevada Cancer Center	Las Vegas	Nevada	United States	89109
15	University of Medicine and Dentistry of New Jersey - MOBILE	Newark	New Jersey	United States	07103
16	Albert Einstein Comprehensive Cancer Center	Bronx	New York	United States	10461
17	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York	United States	10016
18	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
19	Rochester General Hospital	Rochester	New York	United States	14621
20	New York Medical College	Valhalla	New York	United States	10595
21	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
22	Pitt County Memorial Hospital	Greenville	North Carolina	United States	27835-6028
23	Akron City Hospital	Akron	Ohio	United States	44309
24	Hollings Cancer Center	Charleston	South Carolina	United States	29403
25	Palmetto Hematology/Oncology Associates	Spartanburg	South Carolina	United States	29303
26	Harrington Cancer Center	Amarillo	Texas	United States	79106
27	Lone Star Oncology	Austin	Texas	United States	78759
28	Oncology Consultants	Houston	Texas	United States	77024
29	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4009
30	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226