Bladder Cancer Clinical Trial
Official title:
Phase II Study of Tamoxifen for Progressive Metastatic Bladder Cancer Following Previous Platinum-Based Chemotherapy
Verified date | July 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
RATIONALE: Tamoxifen may slow the growth of tumor cells and may be an effective treatment
for patients with metastatic bladder cancer that did not respond to previous chemotherapy.
PURPOSE: This phase II trial is studying how well tamoxifen works in treating patients with
metastatic bladder cancer that did not respond to previous chemotherapy.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed transitional cell carcinoma of the bladder - Evidence of progressive metastatic disease that is unresectable - Stage T4b, N1-3, or M1 disease - Must have received 1-2 prior systemic therapy regimens (chemotherapy, biological therapy, or both) that included at least one platinum-based chemotherapy regimen - Prior perioperative chemotherapy (adjuvant/neoadjuvant therapy) is considered one regimen - Bidimensionally measurable disease (including bone disease) of = 10 mm on spiral CT scan or = 20 mm on conventional CT scan - No uncontrolled CNS metastases - CNS metastases that have been previously treated with radiotherapy are allowed if patient is off corticosteroids PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Bilirubin = 2.0 mg/dL - AST/ALT < 4 times upper limit of normal - Not pregnant - Negative pregnancy test - Fertile patients must use effective barrier or other nonhormonal methods of contraception - No New York Heart Association class III-IV cardiac disease (i.e., congestive heart failure or myocardial infarction within the past 6 months) - No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection) - Not at high risk for deep vein thrombosis, as determined by the physician PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No more than 2 prior systemic therapy regimens, including chemotherapy and/or biological therapy - More than 4 weeks since prior systemic therapy - More than 2 weeks since prior major surgery |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera S. Camillo-Forlanini | Rome | |
United States | Dan L. Duncan Cancer Center at Baylor College of Medicine | Houston | Texas |
United States | Methodist Hospital | Houston | Texas |
United States | Veterans Affairs Medical Center - Houston | Houston | Texas |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 4-month freedom from progression (stable disease, partial response, or complete response) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06034015 -
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04235764 -
En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
|
||
Completed |
NCT02371447 -
VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT04081246 -
Transurethral Modified En Bloc Resection For Large Bladder Tumours.
|
N/A | |
Recruiting |
NCT06059547 -
Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer
|
Phase 2 | |
Terminated |
NCT04779489 -
Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer
|
N/A | |
Not yet recruiting |
NCT04493489 -
Propranolol Adjuvant Treatment of Bladder Cancer
|
Phase 2 | |
Completed |
NCT03520231 -
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
|
Phase 2 | |
Recruiting |
NCT04537221 -
Nordic Cystectomy Study III - Transfusion
|
||
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Completed |
NCT01955408 -
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment
|
N/A | |
Completed |
NCT04487457 -
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05562791 -
A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer
|
Phase 1 | |
Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
Completed |
NCT02781428 -
To Detect the Sensitivity of the UroMark Assay
|
||
Recruiting |
NCT04738630 -
Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
|
Phase 2 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
Active, not recruiting |
NCT03978624 -
Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer
|
Phase 2 | |
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A |