Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00004223

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of docetaxel and gemcitabine in treating patients who have progressive regional or metastatic bladder cancer.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer	Drug: docetaxel Drug: gemcitabine hydrochloride	Phase 2

Detailed Description

OBJECTIVES: I. Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium and failure of only 1 prior systemic regimen treated with docetaxel and gemcitabine. II. Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1 and 8. For patients with complete or partial response or stable disease at 3 weeks, treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months through year 2, every 6 months through year 5, and then annually thereafter until disease progression.

PROJECTED ACCRUAL: A total of 22-45 patients will be accrued for this study over 18-21 months.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium

Study Start Date :

Dec 1, 1999

Actual Primary Completion Date :

Oct 1, 2002

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 progressive regional or metastatic transitional cell carcinoma of the urothelium or mixed histology containing a component of transitional cell carcinoma Failure of only 1 prior chemotherapy regimen for metastatic disease or in the adjuvant or neoadjuvant setting (not containing taxane or gemcitabine) Bidimensionally measurable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase normal OR Alkaline phosphatase no greater than 4 times ULN if SGOT normal OR SGOT less than 1.5 times ULN AND alkaline phosphatase less than 2.5 times ULN Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: No American Heart Association class III or IV heart disease No uncontrolled congestive heart failure No severe cardiac arrhythmias Neurologic: No sensory neuropathy grade 3 or 4 No prior peripheral neuropathy grade 2 or worse Other: No active unresolved infection being treated with parenteral antibiotics within the past 7 days No other malignancy within the past 5 years except: Curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix Clinically unsuspected, organ confined prostate cancer found during cystoprostatectomy Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic response modifier therapy Prior intravesical BCG allowed Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered

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	Duarte	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	Veterans Affairs Medical Center - Tampa (Haley)	Tampa	Florida	United States	33612
10	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
11	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
12	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois	United States	60611-3013
13	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611
14	CCOP - Central Illinois	Decatur	Illinois	United States	62526
15	CCOP - Evanston	Evanston	Illinois	United States	60201
16	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
17	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
18	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
19	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana	United States	46202
20	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
21	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
22	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
23	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
24	Johns Hopkins Oncology Center	Baltimore	Maryland	United States	21231-2410
25	New England Medical Center Hospital	Boston	Massachusetts	United States	02111
26	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
27	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
28	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
29	CCOP - Duluth	Duluth	Minnesota	United States	55805
30	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417
31	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
32	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
33	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
34	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68131
35	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
36	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey	United States	07018-1095
37	Trinitas Hospital - Jersey Street Campus	Elizabeth	New Jersey	United States	07201
38	Hunterdon Regional Cancer Center	Flemington	New Jersey	United States	08822
39	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
40	Kimball Medical Center	Lakewood	New Jersey	United States	08701
41	Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County	Mount Holly	New Jersey	United States	08060
42	Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08901
43	Riverview Medical Center - Booker Cancer Center	Red Bank	New Jersey	United States	07701
44	Overlook Hospital	Summit	New Jersey	United States	07902-0220
45	Veterans Affairs Medical Center - Albany	Albany	New York	United States	12208
46	Albert Einstein Comprehensive Cancer Center	Bronx	New York	United States	10461
47	Veterans Affairs Medical Center - Brooklyn	Brooklyn	New York	United States	11209
48	Veterans Affairs Medical Center - New York	New York	New York	United States	10010
49	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York	United States	10016
50	University of Rochester Cancer Center	Rochester	New York	United States	14642
51	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
52	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
53	Veterans Affairs Medical Center - Cleveland	Cleveland	Ohio	United States	44106
54	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
55	CCOP - Columbus	Columbus	Ohio	United States	43206
56	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
57	CCOP - Sooner State	Tulsa	Oklahoma	United States	74136
58	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
59	Hahnemann University Hospital	Philadelphia	Pennsylvania	United States	19102-1192
60	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104-4283
61	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107-5541
62	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
63	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania	United States	15213-3489
64	Veterans Affairs Medical Center - Pittsburgh	Pittsburgh	Pennsylvania	United States	15240
65	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
66	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57105-1080
67	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee	United States	37212
68	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838
69	Veterans Affairs Medical Center - Madison	Madison	Wisconsin	United States	53705
70	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
71	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin	United States	54449
72	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
73	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin	United States	53295
74	MBCCOP - San Juan	San Juan		Puerto Rico	00927-5800
75	Veterans Affairs Medical Center - San Juan	San Juan		Puerto Rico	00927-5800
76	Pretoria Academic Hospitals	Pretoria		South Africa	0001