Clinical Trials Logo

Clinical Trial Summary

Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. This phase II trial is studying how well bortezomib works in treating patients with advanced transitional cell carcinoma of the urothelium.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the efficacy of PS-341 in patients with measurable advanced urothelial transitional cell carcinoma who have not responded to, or have relapsed after one prior conventional chemotherapy.

II. To determine the safety and toxicity of PS-341 administered in this group of patients.

III. To estimate duration of objective response, progression-free survival and overall survival in this group of patients.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients with a solitary site of disease (i.e., lung or nodal metastases) and who have a partial response (PR) may be considered for surgical resection. Patients with a PR with residual disease after salvage surgery are eligible to continue study therapy. Patients who achieve a complete response, either through resection or bortezomib therapy, receive 2 additional courses of study therapy.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study within 13-17 months. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00072150
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date October 2003

See also
  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 NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Completed NCT01938573 - Sirolimus, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Bladder Cancer Phase 1/Phase 2
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 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
Terminated NCT00003452 - Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder Phase 2
Completed NCT00003167 - Gene Therapy in Treating Patients With Advanced Bladder Cancer Phase 1
Completed NCT00005831 - Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer Phase 2
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
Active, not recruiting NCT04267575 - Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites N/A
Terminated NCT01954173 - Adjuvant Radiation for High Risk Bladder Cancer N/A
Terminated NCT00004856 - Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium Phase 2
Active, not recruiting NCT04670445 - Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer N/A
Terminated NCT01282333 - Veliparib, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Biliary, Pancreatic, Urothelial, or Non-Small Cell Lung Cancer Phase 1
Completed NCT01828736 - Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma Phase 2
Terminated NCT02316548 - Surgery With or Without Postoperative Intensity Modulated Radiation Therapy in Treating Patients With Urothelial Bladder Cancer Phase 2