Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003864

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating patients who have advanced cancer of the esophagus.

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

Detailed Description

OBJECTIVES: I. Evaluate the objective response rate in patients with advanced squamous cell carcinoma of the esophagus treated with carboplatin and docetaxel. II. Assess the toxicity of this regimen in these patients. III. Assess the time to progression and overall survival of this patient population.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, followed by carboplatin IV over 15-30 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until year 2, every 6 months during years 2-5, and then annually thereafter until death.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study at a rate of 30 patients per year.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase II Trial of Docetaxel and Carboplatin in Patients With Advanced Squamous Carcinoma of the Esophagus

Study Start Date :

Jul 1, 1999

Actual Primary Completion Date :

Jan 1, 2004

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 confirmed metastatic or incurable, locally advanced squamous cell carcinoma of the esophagus Measurable disease outside of a previously radiated field required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT no greater than 2 times upper limit of normal Renal: Creatinine normal Cardiovascular: No congestive heart failure or angina pectoris, even if medically controlled No prior myocardial infarction within the past year No clinically significant conduction system abnormalities, such as 2nd or 3rd degree heart block or bundle branch block Pulmonary: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No active infections or medical illnesses that are uncontrolled No second malignancy other than previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix or a prior malignancy from which patient has been disease free for past 3 years Caloric intake greater than 1500 calories/day Fluid intake greater than 1500 mL/day

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	Cancer Center and Beckman Research Institute, City of Hope	Los Angeles	California	United States	91010-3000
3	Veterans Affairs Medical Center - Palo Alto	Palo Alto	California	United States	94304
4	Stanford University Medical Center	Stanford	California	United States	94305-5408
5	CCOP - Colorado Cancer Research Program, Inc.	Denver	Colorado	United States	80209-5031
6	CCOP - Christiana Care Health Services	Wilmington	Delaware	United States	19899
7	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
8	Veterans Affairs Medical Center - Gainsville	Gainesville	Florida	United States	32608-1197
9	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
10	Veterans Affairs Medical Center - Tampa (Haley)	Tampa	Florida	United States	33612
11	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
12	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
13	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois	United States	60611-3013
14	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611
15	CCOP - Central Illinois	Decatur	Illinois	United States	62526
16	CCOP - Evanston	Evanston	Illinois	United States	60201
17	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
18	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
19	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
20	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana	United States	46202
21	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
22	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
23	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
24	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
25	Johns Hopkins Oncology Center	Baltimore	Maryland	United States	21231-2410
26	New England Medical Center Hospital	Boston	Massachusetts	United States	02111
27	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
28	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
29	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
30	CCOP - Duluth	Duluth	Minnesota	United States	55805
31	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417
32	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
33	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
34	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
35	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68131
36	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
37	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey	United States	07018-1095
38	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
39	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
40	Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County	Mount Holly	New Jersey	United States	08060
41	Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08901
42	Raritan Bay Medical Center	Perth Amboy	New Jersey	United States	08861
43	Riverview Medical Center	Red Bank	New Jersey	United States	07701
44	Veterans Affairs Medical Center - Albany	Albany	New York	United States	12208
45	Albert Einstein Comprehensive Cancer Center	Bronx	New York	United States	10461
46	Veterans Affairs Medical Center - Brooklyn	Brooklyn	New York	United States	11209
47	Veterans Affairs Medical Center - New York	New York	New York	United States	10010
48	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York	United States	10016
49	University of Rochester Cancer Center	Rochester	New York	United States	14642
50	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
51	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
52	Veterans Affairs Medical Center - Cleveland	Cleveland	Ohio	United States	44106
53	CCOP - Columbus	Columbus	Ohio	United States	43206
54	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
55	CCOP - Sooner State	Tulsa	Oklahoma	United States	74136
56	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
57	Hahnemann University Hospital	Philadelphia	Pennsylvania	United States	19102-1192
58	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104-4283
59	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107-5541
60	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
61	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania	United States	15213-3489
62	Veterans Affairs Medical Center - Pittsburgh	Pittsburgh	Pennsylvania	United States	15240
63	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
64	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57105-1080
65	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee	United States	37212
66	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838
67	Veterans Affairs Medical Center - Madison	Madison	Wisconsin	United States	53705
68	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
69	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin	United States	54449
70	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
71	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin	United States	53295
72	MBCCOP - San Juan	San Juan		Puerto Rico	00927-5800
73	Veterans Affairs Medical Center - San Juan	San Juan		Puerto Rico	00927-5800
74	Pretoria Academic Hospitals	Pretoria		South Africa	0001