Status:
COMPLETED
Pazopanib and Vinflunine in Urothelial Cancer of the Bladder
Lead Sponsor:
Prof. Dr. Thomas Otto
Conditions:
Advanced Urothelial Cancer of Bladder After Failure of Platinum-containing Therapy.
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Urothelial carcinoma of the bladder mostly is chemically induced and represents the second prevalent urooncological disease. About 20% of newly diagnosed urothelial carcinoma cases of the bladder are ...
Eligibility Criteria
Inclusion
- Written informed consent
- Age ≥ 18 years
- Histologically confirmed Transitional Cell Carcinoma of the Urothelium (TCCU) with lymphatic (N-stage 2-3) and/or distant metastases (M-stage 1) not amenable to definitive regional/local therapy
- Progression of tumor disease after platinum containing systemic chemotherapy for advanced or metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 1
- estimated minimal life expectancy of 3 months at screening
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- Adequate organ system function at screening
- Adequate contraception
Exclusion
- More than 1 prior chemotherapy, biologic therapy or hormonal therapy within 14 days prior to the first dose of study medication
- Prior malignancy within 5 years prior to inclusion (exception: successfully treated basal cell carcinoma or in situ carcinoma)
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 28 days prior to beginning study treatment, e.g
- Active peptic ulcer disease
- Known intraluminal metastatic lesion/s with risk of bleeding
- Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
- History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product, e.g.
- Malabsorption syndrome
- Major resection of the stomach or small bowel
- Active infection requiring antibiotics within 14 days before registration
- Corrected QT interval (QTc) \> 480 msecs using Bazett's formula at screening
- Screening-electrocardiogram (ECG) with any significant modifi¬cations suggesting a high risk of occurrence of an acute clinical event (such as signs of angina pectoris, high risk arrhythmia etc.)
- History of one or more of the following cardiac / cardiovascular conditions within the past 6 months before registration:
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Coronary artery bypass graft surgery
- Symptomatic peripheral vascular disease
- NYHA Class II, III or IV congestive heart failure
- Uncontrolled cardiac arrhythmia
- Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90 mmHg
- History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months before registration
- Peripheral neuropathy grade ≥ 2 (NCI CTC v3.0)
- Unstable diabetes mellitus
- Uncontrolled hypercalcaemia \> 2.9 mmol/L
- Prior major surgery or trauma within 28 days prior to registration and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)
- Evidence of active bleeding e.g. GI bleeding or bleeding diathesis at screening.
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- Hemoptysis with bleeding of \> 2.5 mL within 8 weeks before registration
- Any serious and/or unstable pre-existing medical, psychiatric/psychological, familial, sociological, geographical or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
- prior to the first dose of study drug and for the duration of the study
- Radiation, surgery or tumor embolization or any investigational treatment within 14 days prior to the first dose of study medication
- Any ongoing toxicity from prior anti-cancer therapy that is \> Grade 1 and/or progressing in severity, except nausea, vomiting, alopecia
- ASA 4
- Pre-treatment with Pazopanib or Vinflunine
- Pregnancy or lactation
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01265940
Start Date
March 1 2011
End Date
August 1 2012
Last Update
October 10 2012
Active Locations (1)
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1
Lukaskrankenhaus
Neuss, Germany, 41464