Stage III Bladder Cancer Clinical Trial
Official title:
Phase II Trial of Neoadjuvant Dose Dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer
The purpose of this research study is to find out what effects, good and/or bad, dose-dense (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and cisplatin given before surgery have on patients and their muscle invasive bladder cancer.
PRIMARY OBJECTIVES:
I. To assess the rate of complete response (pT0) at cystectomy following preoperative dose
dense gemcitabine and cisplatin (DD GC) in patients with muscle invasive urothelial carcinoma
of the bladder.
SECONDARY OBJECTIVES:
I. To assess the toxicity profile of DD GC when given in the neoadjuvant setting: To define
the number of patients who complete all three cycles of treatment without dose reduction, and
to describe the incidence of toxicity.
II. To assess the 5 year overall and relapse free survival in patients who receive
neoadjuvant DD GC.
TERTIARY OBJECTIVES:
I. To evaluate tissue specimens from patients to assess for molecular markers that correlate
with clinical outcome.
OUTLINE:
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1 and
cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3
courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks
after chemotherapy, patients undergo radical cystectomy.
After completion of study treatment, patients are followed up for 5 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02122172 -
Afatinib in Advanced Refractory Urothelial Cancer
|
Phase 2 | |
| Completed |
NCT03229278 -
Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma
|
Phase 1 | |
| Completed |
NCT01938573 -
Sirolimus, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Bladder Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
| Terminated |
NCT00112905 -
Sorafenib in Treating Patients With Regional or Metastatic Cancer of the Urothelium
|
Phase 2 | |
| Terminated |
NCT00072137 -
Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy
|
Phase 1 | |
| Completed |
NCT00072150 -
Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT00028756 -
Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium
|
Phase 3 | |
| Completed |
NCT00407485 -
VEGF Trap in Treating Patients With Recurrent, Locally Advanced, or Metastatic Cancer of the Urothelium
|
Phase 2 | |
| Withdrawn |
NCT01639521 -
Gemcitabine Hydrochloride and Cisplatin or High-Dose Methotrexate, Vinblastine, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Urothelial Cancer
|
Phase 2 | |
| Completed |
NCT00003167 -
Gene Therapy in Treating Patients With Advanced Bladder Cancer
|
Phase 1 | |
| Terminated |
NCT02735512 -
MDSC Clinical Assay in Finding and Monitoring Cancer Cells in Blood and Urine Samples From Patients With or Without Localized or Metastatic Bladder Cancer
|
||
| Completed |
NCT00021099 -
Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer
|
Phase 2 | |
| Terminated |
NCT01382706 -
Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder
|
Phase 2 | |
| Terminated |
NCT01954173 -
Adjuvant Radiation for High Risk Bladder Cancer
|
N/A | |
| Completed |
NCT00666562 -
Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer
|
Phase 2 | |
| Completed |
NCT02646319 -
Nanoparticle Albumin-Bound Rapamycin in Treating Patients With Advanced Cancer With mTOR Mutations
|
Early Phase 1 | |
| Terminated |
NCT01282333 -
Veliparib, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Biliary, Pancreatic, Urothelial, or Non-Small Cell Lung Cancer
|
Phase 1 | |
| Terminated |
NCT02316548 -
Surgery With or Without Postoperative Intensity Modulated Radiation Therapy in Treating Patients With Urothelial Bladder Cancer
|
Phase 2 | |
| Completed |
NCT05025748 -
Ask Questions (ASQ):Implementation of a Communication Intervention
|
N/A |