Track topics on Twitter Track topics that are important to you
The purpose of this study is to explore the safety and activity of docetaxel + ASA404 as second-line chemotherapy in patients with advanced urothelial carcinoma.
OUTLINE: This is a multi-center study.
21 Day Cycle Treatment Regimen:
- Docetaxel IV 75 mg/m2 over approximately 60 minutes on Day 1
- ASA404 (given after Docetaxel) IV 1800 mg/m2 over approximately 20 minutes on Day 1
Treatment will continue until disease progression or intolerable treatment related adverse effects.
Karnofsky performance status of ≥ 70% within 7 days prior to registration for protocol therapy.
Life Expectancy: Not specified
- Hemoglobin (Hgb) > 9 g/dL
- Platelets > 100 K/mm3
- Absolute neutrophil count (ANC) > 1.5 K/mm3
- INR or Prothrombin Time (PT) < 1.5 x ULN
- Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST, ALT) < 2.5 x ULN
- Calculated creatinine clearance of > 45 cc/min using the Cockcroft-Gault formula
- No congestive heart failure (NY Heart Association class III or IV)
- No myocardial infarction within 12 months of study registration for protocol therapy or with implanted cardiac pacemaker
- No unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Indiana University Melvin & Bren Simon Cancer Center
Not yet recruiting
Hoosier Oncology Group
Published on BioPortfolio: 2014-08-27T03:15:48-0400
The investigators evaluated the efficacy of a single early intravesical instillation of doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal ureterectomy fo...
This study evaluates the safety and efficacy of the combination of Avelumab, (a fully human anti-programmed death ligand 1 (PD-L1) IgG1 antibody) in combination with a taxane chemotherapy ...
The purpose of this study is to evaluate the overall response rate (ORR) of INCB054828 as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harbo...
This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive locall...
Primary Objective: To study if lycopene can improve the biomarker status of urothelial cells in patients with uremia-associated urothelial carcinoma. Secondary Objective: To evaluate the ...
Current literature supports the efficacy of anti-PD-1 and anti-PD-L1 immune checkpoint inhibitors for the treatment of urothelial carcinomas. While the prognostic value of PD-1 and PD-L1 levels has be...
Immunohistochemical (IHC) staining for CK5/6, CD44, and CK20 has been significantly associated with the prognosis of urinary bladder urothelial carcinoma and probably reflects its molecular characteri...
To compare frequency of new and recurrent urothelial cell carcinoma (UCC) among patients with and without pseudodiverticulosis on imaging.
To compare renal function after radical nephrectomy for renal cell carcinoma (RCC) and for upper tract urothelial carcinoma (UTUC).
To evaluate microRNA biomarkers for upper tract urothelial carcinoma (UTUC) to improve risk stratification.
A condition in which abnormal cells have not spread outside the duct, lobule, or nipple to other tissues of the breast. There are 3 types of breast carcinoma in situ: DUCTAL CARCINOMA IN SITU; LOBULAR CARCINOMA IN SITU; and PAGET DISEASE OF THE NIPPLE
A transplantable carcinoma of the rat that originally appeared spontaneously in the mammary gland of a pregnant albino rat, and which now resembles a carcinoma in young transplants and a sarcoma in older transplants. (Stedman, 25th ed)
An adenocarcinoma characterized by the presence of cells resembling the glandular cells of the ENDOMETRIUM. It is a common histological type of ovarian CARCINOMA and ENDOMETRIAL CARCINOMA. There is a high frequency of co-occurrence of this form of adenocarcinoma in both tissues.
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
A heterogeneous group of sporadic or hereditary carcinoma derived from cells of the KIDNEYS. There are several subtypes including the clear cells, the papillary, the chromophobe, the collecting duct, the spindle cells (sarcomatoid), or mixed cell-type carcinoma.
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...