Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

OBJECTIVES:

Primary

- To assess the 4-month freedom from progression in patients with progressive metastatic transitional cell carcinoma of the bladder treated with tamoxifen citrate.

Secondary

- To determine the objective response rate.

- To correlate response with estrogen-receptor status of the metastatic tumor.

- To collect data on the toxicity and safety profile of this regimen.

- To assess the overall survival.

OUTLINE: This is a multicenter study.

Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Tumor tissue samples are analyzed for tumor estrogen receptors a and b by immunohistochemical (IHC) staining. Tumor tissue and blood samples are stored for future correlative biomarker studies.

After completion of study treatment, patients are followed every 2 months for up to 6 months. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00589017
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Recruiting
Phase Phase 2
Start date July 2005

See also
  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