Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma
- Registration Number
- NCT01071928
- Lead Sponsor
- Hoosier Cancer Research Network
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Docetaxel and ASA404 in Combination Docetaxel - Docetaxel and ASA404 in Combination ASA404 -
- Primary Outcome Measures
Name Time Method 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. 12 months
- Secondary Outcome Measures
Name Time Method To evaluate progression-free survival in patients with advanced urothelial carcinoma 12 months To evaluate survival at 1 year from start of treatment in patients with advanced urothelial carcinoma treated with docetaxel + ASA404 as second line therapy 12 months To evaluate the safety of docetaxel and ASA404 combination, as measured by the NCI Common Toxicity Criteria version 3.0 12 months