Stage IV Bladder Cancer Clinical Trial
Official title:
A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium
Phase II trial to study the effectiveness of ixabepilone in treating patients who have progressive or metastatic urinary tract cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Status | Completed |
Enrollment | 45 |
Est. completion date | |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed transitional cell carcinoma (TCC) of the urothelium(renal pelvis, ureter, bladder, or urethra) - Mixed histology carcinoma with a TCC component allowed - Progressive regional disease - Metastatic disease - Failed 1 and only 1 prior systemic chemotherapy regimen containing cisplatin or carboplatin in the adjuvant, neoadjuvant, or metastatic setting - May have included taxane-based therapy - Measurable disease outside prior irradiation field - Previously resected and irradiated CNS metastases with evidence of stable disease allowed - Performance status - ECOG 0-2 - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin no greater than 1.5 mg/dL - AST no greater than 2.5 times upper limit of normal - Creatinine no greater than 1.5 mg/dL - No prior severe cardiovascular disease (American Heart Association class III or IV heart disease) - No uncontrolled congestive heart failure - No ventricular dysrhythmia - No active unresolved infection requiring parenteral antibiotics within the past week - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or clinically unsuspected organ-confined prostate cancer treated with prior prostatectomy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior systemic biologic response modifier therapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy and recovered - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy - See Disease Characteristics - At least 4 weeks since prior major surgery and recovered |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Eastern Cooperative Oncology Group | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of patients with clinical response measured using RECIST criteria | Up to 3 years | No | |
Secondary | Toxicity graded using the NCI CTC version 2.0 | Up to 30 days after completion of study treatment | Yes |
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 | |
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 | |
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 |