Bladder Cancer
- A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single-Dose Intravesical EOquin as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Non-Invasive Bladder Cancer
- Randomized Study of Larotaxel + Cisplatin (LC) versus Gemcitabine + Cisplatin (GC) in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single-Dose Intravesical EOquin as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Non-Invasive Bladder Cancer
Eligibility Criteria (per Protocol dated 12/20/07):
- Transitional cell carcinoma of the bladder with clinically apparent Ta, Grade G1-G2.
- Females of childbearing potential must have a negative serum pregnancy test 14 days prior to study entry.
- Subject not eligible if there are more than 4 bladder tumors.
- Subject not eligible if any single bladder tumor exceeds 3.5 cm in diameter.
- Subject not eligible if he/she has received EOquin in the past.
- Subject not eleigible if there is an ative urinary tract infection.
- Subject not eligible if there is a histroy of interstitial cystitis.
- Subject not eligible if there is a history of allergy to red color food dye.
- Subject not eligible if he/she has had transtional cell carcinoma of the bladder within 4 months prior to study entry.
- Other critreria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.
Randomized Study of Larotaxel + Cisplatin (LC) versus Gemcitabine + Cisplatin (GC) in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
Eligibility Criteria (per Protocol dated 03/11/09):
- Histologically/Cytologically confirmed Transitional Cell Carcinoma (TCC) with Locally advanced (T4b) or metastatic (lymph node or visceral) urothelial tract or bladder cancer).
- ECOG Performance status of 0 or 1.
- No prior palliative chemotherapy.
- Not eligible if the disease is localized only to the radiation fields without radiologically confirmed progression of the disease within the radiation fields after complation of prior radiotherapy.
- Not eligible if there has been treatment with another investigational drug within 4 weeks prior to study enrollment.
- Not eligible if there is a history or new evidence of brain metastases or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
- Not eligible if there is history of inflammatory bowel disease or of significant bowel obstruction.
- Not eligible if subject has HIV or AIDS.
- Not eligible if there is a concurrent participation in another clinical trial or if there is concurrent treatment with any other anti-cancer therapy at the time of enrollment.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.