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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 CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Metropolitan HospitalGrand Rapids, Michigan  49506
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Finger Lakes Hematology and OncologyClifton Springs, New York  14432
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Stormont-Vail Cancer CenterTopeka, Kansas  66604
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Bay Regional Medical CenterBay City, Michigan  48708
Mecosta County Medical CenterBig Rapids, Michigan  49307
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Cleveland Clinic - WoosterWooster, Ohio  44691
Cancer Therapy and Research CenterSan Antonio, Texas  78229
University Hospital - San AntonioSan Antonio, Texas  78229
Danville Regional Medical CenterDanville, Virginia  24541
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Pearlman Comprehensive Cancer Center at South Georgia Medical CenterValdosta, Georgia  31603
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
St. Joseph Cancer CenterBellingham, Washington  98225
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Sletten Regional Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Clinic of Dr. Judy L. SchmidtMissoula, Montana  59804