Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer



Status:Completed
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 1999
End Date:November 2013

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A Phase I/II Trial in Patients With Muscle-Invading Bladder Cancer of Transurethral Surgery Plus Taxol, Cisplatin and Bid Irradiation Followed by Either Selective Bladder Preservation or Radical Cystectomy and Adjuvant Chemotherapy

RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy
use different ways to stop tumor cells from dividing so they stop growing or die. Combining
radiation therapy with chemotherapy and surgery may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination
chemotherapy in treating patients who have stage II or stage III bladder cancer that can be
removed by surgery.

OBJECTIVES:

- Evaluate the safety and tolerability of induction chemoradiotherapy with paclitaxel and
cisplatin followed by selective bladder preservation or radical cystectomy and adjuvant
chemotherapy in patients with stage II or III muscle invasive carcinoma of the bladder
previously treated with transurethral tumor resection.

- Evaluate the efficacy of transurethral tumor resection and induction chemoradiotherapy
in achieving a complete response in this patient population.

- Assess the value of tumor parameters as prognostic factors for initial tumor response
and recurrence-free survival in this patient population.

OUTLINE: Four to six weeks after prior transurethral resection, patients receive induction
therapy comprising paclitaxel IV over 1 hour on days 1, 8, and 15, cisplatin IV over 1 hour
on days 1, 2, 8, 9, 15, and 16, and radiotherapy twice daily on days 1-5, 8-12, and 17.

Four weeks after induction therapy, patients undergo urologic evaluation. At 1-2 weeks after
evaluation, patients with complete response receive consolidation therapy comprising
paclitaxel IV over 1 hour on days 1 and 8, cisplatin IV over 1 hour on days 1, 2, 8, and 9,
and radiotherapy twice daily on days 1-5 and 8-10. Patients with poor tumor response undergo
a cystectomy.

At 12 weeks postconsolidation therapy or 8 weeks post radical cystectomy, patients receive
adjuvant chemotherapy comprising gemcitabine IV over 30-60 minutes followed by cisplatin IV
over 1 hour every 3 weeks. Treatment repeats every 4 weeks for 4 courses in the absence of
disease progression or unacceptable toxicity.

Patients are followed every 4 months for 1 year, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 3 years.

DISEASE CHARACTERISTICS:

- Histologically confirmed stage II or III (T2-4a, Nx or N0, M0) primary carcinoma of
the bladder with muscle invasion

- Resectable disease

- Prostatic urethral involvement with transitional cell carcinoma allowed, if
completely resected and no evidence of stromal invasion

- No tumor-related hydronephrosis

- Positive lymph node must be evaluated by lymphadenectomy or percutaneous needle
biopsy

- No nodal metastases

- No distant metastases

- No more than 6 weeks since prior transurethral resection of the bladder tumor

- Functioning bladder

PATIENT CHARACTERISTICS:

Age:

- Adult

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Hemoglobin at least 10 g/dL

- White blood cell (WBC) count of at least 4,000/mm^3

- Absolute neutrophil count at least 1,800/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

Renal:

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

Other:

- No other prior or concurrent malignancy within the past 5 years except curatively
treated nonmelanoma skin cancer, stage I prostate cancer, or carcinoma in situ of the
cervix

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- Medically operable

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior systemic chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior pelvic radiotherapy

Surgery:

- See Disease Characteristics

Other:

- No concurrent potential nephrotoxic or ototoxic drugs (e.g., aminoglycosides)
We found this trial at
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175 Madison Avenue
Mount Holly, New Jersey 08060
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Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Virtua Memorial is a...
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Baltimore, Maryland 21231
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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300 Community Drive
Manhasset, New York 11030
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1331 Union Ave # 800
Memphis, Tennessee 38103
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4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
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620 John Paul Jones Cir
Portsmouth, Virginia 23708
(757) 953-5008
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800 West 5th Avenue
Spokane, Washington 99210
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
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Albuquerque, New Mexico 87109
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
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6701 North Charles Street
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443-849-3051
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2401 W Belvedere Ave
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Baton Rouge, Louisiana 70809
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601 West 2nd Street
Bloomington, Indiana 47402
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55 Fruit St
Boston, Massachusetts 02114
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Charlottesville, Virginia 22908
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251 E Huron St
Chicago, Illinois 60611
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
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Cleveland, Ohio 44106
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
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Clifton Springs, New York 14432
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Colorado Springs, Colorado 80909
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
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Concord, California 94524
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Concord, North Carolina 28025
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
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Darby, Pennsylvania 19023
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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1600 Southwest Archer Road
Gainesville, Florida 32610
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2635 North 7th Street
Grand Junction, Colorado 81502
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1 Ingalls Dr
Harvey, Illinois 60426
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
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