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Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency


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

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Trial Information

Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency


OBJECTIVES:

- Determine the response rate of patients with progressive regional or metastatic
transitional cell carcinoma of the urothelium with renal insufficiency when treated
with paclitaxel and gemcitabine.

- Determine the toxicity of this regimen in this patient population.

OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV
over 30 minutes on days 1, 8, and 15. Treatment continues every 4 weeks for a minimum of 3
courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for this study within 10-27
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed progressive regional or metastatic transitional cell
carcinoma of the urothelium

- Mixed histologies containing a component of transitional cell carcinoma allowed

- Bidimensionally measurable disease

- No clinical evidence of CNS metastases

- Clinically unsuspected organ-confined prostate cancer found at time of
cystoprostatectomy allowed

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

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

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 2.5 times upper limit of normal (ULN) and alkaline phosphatase
normal OR

- Alkaline phosphatase no greater than 4 times ULN and SGOT normal OR

- SGOT less than 1.5 times ULN and alkaline phosphatase less than 2.5 times ULN

Renal:

- Creatinine no greater than 3.0 mg/dL

- Glomerular filtration rate no greater than 50 mL/min

Cardiovascular:

- No history of American Heart Association class III or IV heart disease

- No uncontrolled congestive heart failure

- No severe cardiac arrhythmias

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No preexisting peripheral neuropathy grade 2 or greater

- No active unresolved infection requiring parenteral antibiotics within the past 7
days

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior systemic biologic response modifier therapy for advanced disease

- Prior intravesical BCG for superficial disease allowed

Chemotherapy:

- Prior intravesical chemotherapy for superficial disease allowed

- No prior chemotherapy for advanced disease

- At least 6 months since prior adjuvant/neoadjuvant methotrexate, vinblastine,
doxorubicin, and cisplatin (MVAC) or cisplatin, methotrexate, and vinblastine (CMV),
or cisplatin as a radiosensitizer

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior major surgery and recovered

Other:

- No concurrent hemodialysis

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David J. Vaughn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

CDR0000067810

NCT ID:

NCT00005644

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • stage III bladder cancer
  • recurrent bladder cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • recurrent urethral cancer
  • distal urethral cancer
  • proximal 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
  • Renal Insufficiency
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Medical College of WisconsinMilwaukee, Wisconsin  53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - Scott and White HospitalTemple, Texas  76508
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
James P. Wilmot Cancer CenterRochester, New York  14642
Albert Einstein Clinical Cancer CenterBronx, New York  10461