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Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients With Locally Advanced or Recurrent Urothelial Malignancy

Phase 2
18 Years
Not Enrolling
Bladder Cancer, Urethral Cancer

Thank you

Trial Information

Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients With Locally Advanced or Recurrent Urothelial Malignancy


- Determine the overall survival of patients with locally advanced or recurrent carcinoma
of the urothelium treated with neoadjuvant carboplatin, paclitaxel, and gemcitabine
followed by concurrent cisplatin and radiotherapy.

- Determine the feasibility of administering this regimen to these patients.

- Determine the progression-free survival of patients treated with this regimen.

- Determine the qualitative and quantitative toxic effects of this regimen in these

- Determine the response rate (confirmed and unconfirmed) of patients treated with the
neoadjuvant regimen and those treated with the whole regimen.

- Determine the proportion of patients who qualify for concurrent cisplatin and
radiotherapy after receiving the neoadjuvant regimen.

- Determine the potential value of suppressor gene expression analysis (p53 and
retinoblastoma gene) and HER2 expression as indicators of prognosis and/or response in
patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive neoadjuvant chemotherapy comprising paclitaxel IV over 3 hours and
carboplatin IV over 15 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
Treatment repeats every 21 days for a maximum of 3 courses in the absence of disease
progression or unacceptable toxicity.

Within 4-8 weeks after the completion of neoadjuvant chemotherapy, patients receive
cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for a maximum of 2
courses in the absence of disease progression or unacceptable toxicity. Patients also
undergo concurrent radiotherapy 5 days a week for 6 weeks.

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

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 4 years.

Inclusion Criteria


- Histologically confirmed primary or recurrent invasive carcinoma of the urothelium

- Transitional, squamous, or mixed cell subtypes allowed

- Primary disease site must be the urinary bladder or urethra

- Disease confined to the true pelvis (T2-T4, N0-N3, M0)

- Must meet at least 1 of the following criteria:

- Nodal involvement at or below the level of the bifurcation of the iliac

- Medically or surgically inoperable

- Patient refused cystectomy

- Measurable or nonmeasurable disease

- Evidence of tumor invasion of the muscularis by cystoscopy and biopsy and detailed
bladder mapping within the past 56 days

- No extrapelvic metastases

- Eligible to receive radiotherapy

- Planned radiotherapy at a SWOG-approved facility



- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Granulocyte count at least 1,500/mm^3

- Platelet count at least lower limit of normal


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

- SGOT or SGPT no greater than 2.5 times ULN


- Creatinine clearance at least 60 mL/min OR

- Creatinine no greater than ULN


- No chronic diarrhea

- No malabsorption

- No extensive diverticular disease of the colon

- No inflammatory bowel disease

- No other pre-existing gastrointestinal disorders


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No active infections requiring antibiotics

- No other 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 currently in complete remission


Biologic therapy

- Not specified


- No prior chemotherapy for patients with a current diagnosis of advanced bladder
cancer that is also the initial diagnosis

- No prior systemic chemotherapy except adjuvant therapy for recurrent disease
completed more than 6 months ago

- No prior carboplatin

- No prior paclitaxel

- No prior gemcitabine

Endocrine therapy

- Not specified


- See Disease Characteristics

- No prior pelvic radiotherapy


- See Disease Characteristics

- Recovered from prior surgery

Type of Study:


Study Design:

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

Principal Investigator

Ulka N. Vaishampayan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

November 2002

Completion Date:

June 2006

Related Keywords:

  • Bladder Cancer
  • Urethral Cancer
  • recurrent bladder cancer
  • stage III bladder cancer
  • squamous cell carcinoma of the bladder
  • stage II bladder cancer
  • recurrent urethral cancer
  • urethral cancer associated with invasive bladder cancer
  • distal urethral cancer
  • proximal urethral cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms



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