A Phase II Study of Neo-Adjuvant Cisplatin, Gemcitabine & Bevacizumab, Followed by Radical Cystectomy for Patients With Muscle Invasive, Resectable, Non-Metastatic Transitional Cell Carcinoma (TCC) of the Bladder
- Determine the pT0 status (pathologic complete remission rate, no evidence of disease on
cystectomy specimen) in patients with muscle-invasive, resectable, nonmetastatic
transitional cell carcinoma (TCC) of the bladder treated with neoadjuvant cisplatin,
bevacizumab, and gemcitabine hydrochloride followed by radical cystectomy and adjuvant
bevacizumab and paclitaxel.
- Determine if urinary survivin and urocytogenetics can predict responses in patients
with muscle invasive, resectable, non-metastatic TCC of the bladder treated with
neoadjuvant cisplatin and gemcitabine chemotherapy with bevacizumab.
- Evaluate the progression-free and median survival in patients treated with neo-adjuvant
cisplatin and gemcitabine hydrochloride chemotherapy with bevacizumab followed by
- Determine the feasibility, tolerability and toxicity of neoadjuvant cisplatin and
gemcitabine hydrochloride with bevacizumab in patients with muscle invasive,
resectable, nonmetastatic transitional cell carcinoma (TCC) of the bladder.
- Correlate pT0 on cystoscopy with pT0 on radical cystectomy in patients treated with
neoadjuvant cisplatin and gemcitabine hydrochloride chemotherapy with bevacizumab in
patients with muscle invasive, resectable, nonmetastatic transitional cell carcinoma
(TCC) of the bladder.
- Determine the influence of adjuvant paclitaxel plus bevacizumab (in pathologic
non-complete responders) on progression-free and overall survival rates.
- Determine the safety of bevacizumab use in the adjuvant setting in therapy of locally
advanced bladder cancer.
- Determine the rate of postoperative complications, following treatment with neoadjuvant
therapy (cisplatin, gemcitabine hydrochloride, and bevacizumab) and radical cystectomy.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy: Patients receive cisplatin IV over 60 minutes and bevacizumab IV
over 30-90 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1
and 8. Treatment repeats every 3 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients with nonmetastatic disease at 12 weeks
proceed to surgery at least 30 days later.
- Surgery: Patients undergo radical cystectomy. Patients who achieve pT0 status
(pathologic complete remission rate, no evidence of disease on cystectomy specimen) are
observed off study. Patients with evidence of disease proceed to adjuvant therapy.
- Adjuvant therapy: Patients receive bevacizumab IV over 30-90 minutes and paclitaxel IV
over 3 hours on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 6 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Overall pT0 response rate
Andrew S. Kraft, MD
Medical University of South Carolina
United States: Food and Drug Administration
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|Gibbs Regional Cancer Center at Spartanburg Regional Medical Center||Spartanburg, South Carolina 29303|
|McLeod Regional Medical Center||Florence, South Carolina 29501|
|Lowcountry Hematology and Oncology, PA||Mount Pleasant, South Carolina 29464-3233|