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Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (and in a Cohort of Patients Younger Than 60 Years)


Phase 2
N/A
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Thank you

Trial Information

Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (and in a Cohort of Patients Younger Than 60 Years)


OBJECTIVES:

- Determine the feasibility of enrolling patients aged 70 years and older with advanced
or recurrent urothelial cancer to a structured phase II study.

- Determine the anticancer efficacy of gemcitabine and paclitaxel, in terms of objective
response rate and 2-year survival, in these elderly patients.

- Assess the toxicity and tolerability of this regimen in these elderly patients.

- Determine the feasibility of using standardized self-report measures of comorbidity,
depression, and functional status in these patients.

- Determine the pharmacokinetics of this regimen in these elderly patients and validate
this data against similar parameters in patients aged under 60 years.

OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over
vs under 60).

Patients receive paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30 minutes on
days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of
disease progression or unacceptable toxicity.

Quality of life is assessed at baseline.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 80 patients (60 age 70 and over and 20 under age 60) will be
accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed urothelial cancer

- Transitional cell carcinoma, adenocarcinoma, or squamous carcinoma (bladder,
renal pelvis, ureter, or urethra)

- Previously untreated metastatic or locoregionally advanced (i.e., bulky pelvic nodes)
disease OR

- Locally recurrent carcinoma after radiotherapy or cystectomy and no longer eligible
for further radiotherapy or surgery

- Measurable disease

PATIENT CHARACTERISTICS:

Age:

- 70 and over OR

- Under 60

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,200/mm^3

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

Hepatic:

- Bilirubin no greater than upper limit of normal (ULN)

- SGOT or SGPT no greater than 2 times ULN

Renal:

- Creatinine no greater than ULN

Other:

- HIV negative

- No other concurrent life-threatening medical disorder that would preclude study
participation

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately
treated stage I or II cancer in complete remission

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Prior adjuvant chemotherapy is allowed provided administered more than 10 years ago

- No prior gemcitabine, taxanes, or platinum-based adjuvant chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 28 days since prior radiotherapy and recovered

Surgery:

- See Disease Characteristics

- At least 28 days since prior surgery and recovered

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Study treatment feasibility

Outcome Time Frame:

monthly for duration of accrual

Safety Issue:

No

Principal Investigator

Derek Raghavan, MD, PhD, FRACP, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068837

NCT ID:

NCT00022633

Start Date:

July 2001

Completion Date:

July 2011

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • recurrent bladder cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • squamous cell carcinoma of the bladder
  • adenocarcinoma of the bladder
  • recurrent urethral cancer
  • anterior urethral cancer
  • posterior urethral cancer
  • urethral cancer associated with invasive bladder cancer
  • metastatic transitional cell cancer of the renal pelvis and ureter
  • regional transitional cell cancer of the renal pelvis and ureter
  • recurrent transitional cell cancer of the renal pelvis and ureter
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms
  • Urologic Neoplasms

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
Medical City Dallas Hospital Dallas, Texas  75230
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Grand Rapids Grand Rapids, Michigan  49503
CCOP - Scott and White Hospital Temple, Texas  76508
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Interlakes Oncology/Hematology PC Rochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Southwest Medical Center Liberal, Kansas  67901
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Metropolitan Hospital Grand Rapids, Michigan  49506
Holland Community Hospital Holland, Michigan  49423
Hackley Hospital Muskegon, Michigan  49443
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
St. James Community Hospital Butte, Montana  59701
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Spectrum Health Hospital - Butterworth Campus Grand Rapids, Michigan  49503
Finger Lakes Hematology and Oncology Clifton Springs, New York  14432
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Stormont-Vail Cancer Center Topeka, Kansas  66604
St. Francis Comprehensive Cancer Center Topeka, Kansas  66606
Bay Regional Medical Center Bay City, Michigan  48708
Mecosta County Medical Center Big Rapids, Michigan  49307
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Wilson Medical Center Wilson, North Carolina  27893-3428
Community Oncology Group at Cleveland Clinic Cancer Center Independence, Ohio  44131
Cleveland Clinic - Wooster Wooster, Ohio  44691
Cancer Therapy and Research Center San Antonio, Texas  78229
University Hospital - San Antonio San Antonio, Texas  78229
Danville Regional Medical Center Danville, Virginia  24541
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Pearlman Comprehensive Cancer Center at South Georgia Medical Center Valdosta, Georgia  31603
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
St. Joseph Cancer Center Bellingham, Washington  98225
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Rutherford Hospital Rutherfordton, North Carolina  28139
AnMed Health Cancer Center Anderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Sletten Regional Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Clinic of Dr. Judy L. Schmidt Missoula, Montana  59804