Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma
A Phase II Trial of Docetaxel Plus ASA404 as Second-Line Therapy in Patients With Advanced Urothelial Carcinoma: Hoosier Oncology Group GU09-144
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 Hematopoietic: - 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 Hepatic: - Bilirubin < 1.5 x ULN - Aspartate aminotransferase (AST, ALT) < 2.5 x ULN Renal: - Calculated creatinine clearance of > 45 cc/min using the Cockcroft-Gault formula Cardiovascular: - 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
To determine the best overall response rate (as measured by RECIST version 1.1) of docetaxel + ASA404 as second line therapy in patients with advanced urothelial carcinoma.
To evaluate progression-free survival in patients with advanced urothelial carcinoma
Study Arms / Comparison Groups
Docetaxel and ASA404 in Combination
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria: - Histological or cytological proof of transitional cell carcinoma (TCC) of the bladder, urethra, ureter, or renal pelvis (urothelial carcinoma). Histology may be mixed, but still requires a component of TCC. - Measurable disease according to RECIST (version 1.1) and obtained by imaging within 30 days prior to registration for protocol therapy. Note: Sites of measurable disease can not be within a previously irradiated site. - Written informed consent and HIPAA authorization for release of personal health information. - Age > 18 years at the time of consent. - Must have received only one prior chemotherapy regimen, which must have included one of the following chemotherapeutic agents: cisplatin, carboplatin, or gemcitabine. Note: Prior chemotherapy may have been administered in the perioperative (neoadjuvant/adjuvant) or advanced/metastatic setting. Patients may have received prior treatment with paclitaxel. - Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 12 weeks after treatment discontinuation. - Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy. - Females must not be breastfeeding. Exclusion Criteria: - No prior treatment with docetaxel. - No symptomatic brain metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. NOTE: Patients with treated brain metastasis must be off steroids and have completed radiation at least 14 days prior to registration for protocol therapy. - No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancers for which the patient has been disease-free for at least 5 years - No treatment with any investigational agent or chemotherapeutic agent within 30 days prior to registration for protocol therapy. - No radiotherapy within 14 days prior to registration for protocol therapy. Patients must have recovered from all radiotherapy-related toxicities. - No major surgery within 30 days prior to registration for protocol therapy (major surgery is defined by the use of general anesthesia). - No minor surgery 14 days prior to registration for protocol therapy. NOTE: Insertion of a vascular access device is allowed. - No history of any medical condition resulting in ≥ CTC grade 2 dyspnea. - Patients without long QT syndrome - No history of labile hypertension or poor compliance with anti-hypertensive regimen NOTE: No patients with systolic BP >140 mm Hg and/or diastolic BP > 90 mm Hg while on medication for hypertension. - No presence of atrial tachyarrhythmia (e.g., atrial fibrillation, atrial flutter, multifocal atrial tachycardia, supraventricular tachycardia) if not effectively rate-controlled. - No history of a sustained ventricular tachycardia - No history of ventricular fibrillation or Torsades de Pointes - No right bundle branch block and left anterior or posterior hemiblock (bifascicular block) - No bradycardia defined as heart rate <50 beats per minute - No concomitant use of drugs with risk of causing Torsades de Pointes. - No concomitant use of drugs that are inducers and inhibitors of UGT1A9 and UGT2B7.
18 Years - N/A
Accepts Healthy Volunteers
Matthew Galsky, M.D., ,
Hoosier Cancer Research Network
Matthew Galsky, M.D., Study Chair, Hoosier Cancer Research Network