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A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Urothelial Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin With Molecular Correlates

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

Thank you

Trial Information

A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Urothelial Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin With Molecular Correlates


- Determine the pathologic complete response of patients with stage II or III
transitional cell cancer of the urothelium treated with neoadjuvant gemcitabine,
paclitaxel, and carboplatin followed by observation or immediate cystectomy.

- Determine, preliminarily, if molecular markers predict response, survival, and tumor
recurrence in patients treated with these regimens.

- Determine recurrence rates and cystectomy-free survival of patients who choose
observation after an initial response to neoadjuvant chemotherapy.

- Compare the survival of patients treated with neoadjuvant chemotherapy followed by
cystectomy vs observation.

- Determine the feasibility, tolerability, and toxicity of these regimens in these

OUTLINE: This is a multicenter study.

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

Within 4-8 weeks after completion of neoadjuvant chemotherapy, patients undergo a third
transurethral resection of bladder tumor.

Patients with T0 disease after neoadjuvant chemotherapy may choose to undergo observation.
These patients undergo cystoscopies with biopsies every 3 months for 1 year, every 4 months
for 1 year, and then every 6 months until disease progression.

Patients with T1 disease or greater after neoadjuvant chemotherapy undergo immediate
cystectomy. Patients with T0 disease may also choose this option. Patients undergoing
immediate cystectomy are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study within 2 years.

Inclusion Criteria


- Histologically confirmed muscle-invasive (T2-T4a), node-negative (N0) urothelial
transitional cell cancer (TCC) of the bladder

- Focal squamous and/or adenocarcinoma differentiation, defined as ≤ 10% of tumor
volume allowed

- The following diagnoses are not allowed:

- Small cell carcinoma

- Sarcomatoid components

- Disease diagnosed with an initial transurethral resection of bladder tumor (TURBT)
and a second TURBT performed within 8 weeks of first with attempt to remove all tumor

- Residual disease after second TURBT allowed

- No more than 14-56 days after second TURBT

- No metastatic disease by chest x-ray and CT scan or MRI of the abdomen and pelvis

- Fresh tumor tissue, paraffin tumor tissue, unstained slides, or cell block specimen
from one or both TURBTs available



- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- White blood cell count (WBC) at least 3,500/mm^3

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

- Platelet count at least lower limit of normal


- Bilirubin no greater than 1.5 mg/dL

- Aspartate aminotransferase (SGOT) no greater than 2 times upper limit of normal


- Creatinine no greater than 2.0 mg/dL AND/OR

- Creatinine clearance at least 60 mL/min


- No prohibitive medical risk that would preclude radical cystectomy

- No other serious concurrent systemic disorder that would preclude study compliance

- No other malignancy except adequately treated basal cell or squamous cell skin
cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer in
complete remission, or any other cancer for which patient has been disease-free for 5

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy

- Prior intravesical immunotherapy allowed


- No prior systemic chemotherapy for TCC of the urothelium

- Prior intravesical chemotherapy allowed

Endocrine therapy

- Not specified


- No prior radiotherapy for TCC of the urothelium

- No concurrent radiotherapy


- See Disease Characteristics

Type of Study:


Study Design:

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

Outcome Measure:

Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy

Outcome Description:

Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.

Outcome Time Frame:

up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )

Safety Issue:


Principal Investigator

Primo N. Lara, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis


United States: Federal Government

Study ID:




Start Date:

January 2003

Completion Date:

December 2011

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • anterior urethral cancer
  • localized transitional cell cancer of the renal pelvis and ureter
  • posterior urethral cancer
  • stage II bladder cancer
  • stage III bladder cancer
  • transitional cell carcinoma of the bladder
  • urethral cancer associated with invasive bladder cancer
  • regional transitional cell cancer of the renal pelvis and ureter
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms



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