Stage III Bladder Cancer Clinical Trial
Official title:
Phase II Trial of Neoadjuvant Dose Dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer
Verified date | July 2019 |
Source | Fox Chase Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 32 |
Est. completion date | January 22, 2019 |
Est. primary completion date | July 12, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must have histologically confirmed urothelial carcinoma of the bladder or urethra; patients with urothelial carcinoma of the prostatic urethra only may be included at primary investigator (PI) discretion; T-stage must be T2 to T4a; patients with radiographic N0 disease or N1 disease are eligible for the study; patients must not have radiographic evidence of metastatic disease; mixed histologies which are predominantly urothelial, such as with squamous or micropapillary differentiation, are allowed so long as there is no component of small cell histology; histology must be confirmed by a pathologist at an institution involved in this study - Patients must be candidates for radical cystectomy with the goal of cure - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Leukocytes >= 3,000/mcL - Absolute neutrophil count >= 1,500/mcL - Platelets >= 100,000/mcL - Total bilirubin =< institutional upper limit of normal (ULN) - Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN - Patients must have adequate renal function defined as creatinine clearance >= 50 mL/min; for eligibility, creatinine clearance may be either calculated using the Cockcroft-Gault formula or measured with 24 hour urine collection; note that 24 hour urine collection is required at baseline, but does not have to be used for eligibility if calculated clearance by Cockcroft-Gault is preferred; nephrostomy or ureteral stent placement in order to achieve adequate creatinine clearance is allowed - Women of child-bearing potential (WOCBP) and men with a female partner who is a WOCBP must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting prior to beginning treatment and continuing until at least 3 months after last dose of chemotherapy and surgery; should a woman become pregnant or suspect she is pregnant while participating in this study or if a female partner of a man participating in this study becomes pregnant, the treating physician must be notified immediately; WOCBP must have a negative serum or urine pregnancy test within 7 days prior to initiating study treatment - No other active malignancy - Ability to understand and the willingness to sign written informed consent and Health Insurance Portability and Accountability Act (HIPAA) documents Exclusion Criteria: - Patients who have had intravesicular therapy within 4 weeks of study entry, or those who have not recovered from adverse effects of such agents administered more than 4 weeks earlier - Patients may not be receiving any investigational agents within 4 weeks of study entry - History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or cisplatin or other agents used in the study - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant women are excluded from this study - Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible - Patients who have undergone prior radiation to greater than or equal to 25% of the bone marrow within the past year are excluded - Patients who have received any previous systemic chemotherapy or radiation therapy for urothelial carcinoma within 1 year of study entry are ineligible |
Country | Name | City | State |
---|---|---|---|
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University, Kimmel Cancer Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Fox Chase Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathological Complete Response Rate Following Chemotherapy Before Surgery | Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy | Up to 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 | |
Completed |
NCT00072150 -
Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
|
Phase 2 | |
Terminated |
NCT00072137 -
Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy
|
Phase 1 | |
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 |