EUCTR2009-015119-42-DE
Active, not recruiting
Not Applicable
An open-label, randomised, multicentre, phase II study to evaluate the efficacy of chemotherapy with gemcitabine and cisplatin in combination with the EGF receptor antibody panitumumab (GemCisP) versus GemCis in the first-line therapy of locally advanced/metastatic urothelial carcinoma in patients with wild-type HRAS - PURO
GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH0 sitesFebruary 11, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed urothelial carcinoma of the bladder or the upper urinary tract
- •Wild\-type HRAS
- •Male and female subjects \> 18 years of age
- •General condition ECOG 0\-1
- •Life expectancy at least 12 weeks
- •Women of child\-bearing potential: negative pregnancy test and use of effective contraception (oral contraceptive, coil); men: use of adequate male contraception (condom) for up to 3 months after discontinuation of panitumumab therapy
- •Locally advanced or metastatic disease (T3b,T4 and/or N\+ and/or M\+)
- •At least one unidimensionally measurable lesion detectable in CT or MRI corresponding to the RECIST criteria
- •Adequate haematological, hepatic, renal and metabolic function parameters:
- •Leukocytes \> 3000/mm³, ANC \= 1500/mm³, platelets \= 100,000/mm³, hemoglobin \> 9 g/dl, Creatinine clearance \= 50 ml/min and serum creatinine \= 1\.5 x upper limit of normal, Bilirubin \= 1\.5 x upper limit of normal, GOT\-GPT \= 2\.5 x upper limit of normal in absence of liver metastases, or \= 5 x upper limit of normal in presence of liver metastases, AP \= 5 x upper limit of normal, Magnesium \= lower limit of normal, Calcium \= lower limit of normal, INR and PTT \< 1\.5 x the upper limit of the normal reference range
Exclusion Criteria
- •HRAS mutation
- •Absence of any of the above\-listed inclusion criteria
- •Dialysis\-dependence following nephrectomy
- •Patients with cerebral tumours and/or cerebral metastases
- •Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) \= 1 year before enrolment.
- •Patients with uncontrolled hypertension; systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg despite optimal medical treatment
- •History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •Patients with thrombotic or embolic events, such as stroke or pulmonary embolism
- •Patients with recent or known history of haemorrhagic diathesis
- •Known significant neurological or psychiatric disorders, including dementia and epileptic seizures
Outcomes
Primary Outcomes
Not specified
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