Stage IV Bladder Cancer Clinical Trial
Official title:
Phase II Trial of PS-341 (Bortezomib) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
Verified date | June 2013 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | March 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologic diagnosis of transitional cell carcinoma (TCC) of the bladder, urethra, ureter or renal pelvis; histologic documentation of metastatic/recurrent disease is not required; clinical staging, but not pathological staging, is required - All patients must have received only one prior systemic chemotherapy regimen for advanced or metastatic disease (which must have included at least one of the following chemotherapy agents: cisplatin, carboplatin, paclitaxel, docetaxel or gemcitabine), with progression documented during or after that treatment; neoadjuvant as well as adjuvant combination chemotherapy is considered a systemic chemotherapy; radiosensitizing single agent chemotherapy is not considered prior systemic therapy - Patients must have completed radiotherapy (RT) or chemotherapy >= 4 weeks prior to registration on this trial; patients must have recovered from previous treatments or returned to their baseline in the judgment of the enrolling physician - No Prior treatment with PS-341 or other proteasome inhibitors - No prior treatment with investigational agents as single agent therapy; however, the incorporation of an investigational agent into the prior systemic chemotherapy regimen is allowed - Patients must have measurable disease; - Measurable Disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as >10 mm with spiral CT scan - Non-measurable disease: Patients with ONLY non-measurable disease are not eligible for this trial - Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions, which include the following: - Bone lesions; - Leptomeningeal disease; - Ascites; - Pleural/pericardial effusion; - Inflammatory breast disease; - Lymphangitis cutis/pulmonis; - Abdominal masses that are not confirmed and followed by imaging techniques; - Cystic lesions - Primary bladder masses - CTC (ECOG) performance status =< 2 - Patients must have =< grade 1 peripheral neuropathy at baseline - No known active brain metastases; patients may not have evidence of active brain metastases; screening CT or MRI is not required, unless there is clinical suspicion of brain metastases - Pregnant and/or nursing women are not eligible for this trial as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study; pregnant and/or nursing women are not eligible for this trial as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study - Creatinine =< 2.5 mg/dl or measured or calculated creatinine clearance > 30 ml/min) - ALT and AST =< 2.5 x ULN - Total bilirubin =< 1.8 mg/dL - Granulocytes >= 1500/mm^3 - Platelets >= 100,000/mm^3 - Hemoglobin >= 8 g/dl |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UCSF-Mount Zion | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rates (CR+PR) determined according to the RECIST criteria | 95% confidence intervals will be computed using the binomial distribution. | Up to 6 years | No |
Secondary | Duration of objective response | The Kaplan-Meier product-limit method will be used to estimate. | From the date of the first CR or PR to the date that the patient had disease progression (or death), assessed up to 6 years | No |
Secondary | Toxicity by type, frequency, and severity | 95% confidence intervals for the toxicity rates will be computed using the binomial distribution. | Up to 6 years | Yes |
Secondary | Progression free survival | The Kaplan-Meier product-limit method will be used to estimate. | From the date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 6 years | No |
Secondary | Overall survival | The Kaplan-Meier product-limit method will be used to estimate. | From the date of initiation of treatment to date of death due to any cause, assessed up to 6 years | No |
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 |