Locally advanced/metastatic urothelial carcinoma MedDRA version: 12.1 Level: LLT Classification code 10046721 Term: Urothelial carcinoma bladder stage III MedDRA version: 12.1 Level: LLT Classification code 10046722 Term: Urothelial carcinoma bladder stage IV MedDRA version: 12.1 Level: LLT Classification code 10046724 Term: Urothelial carcinoma ureter local MedDRA version: 12.1 Level: LLT Classification code 10046725 Term: Urothelial carcinoma ureter metastatic
Conditions
Sponsors
GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 • Serious inflammatory eye conditions, hearing impairment • Pulmonary (pO2 grade 2 NCI CTC Version 3) • Chronic hepatitis B or C; HIV infection • Autoimmune disease • Allergic reaction to one of the medications to be used • Status post organ transplantation • Status post autologous bone marrow transplantation or stem cell transplantation in the 4 months prior to study commencement • Manifest secondary malignancy or other form of cancer in the previous 5 years (excluding basalioma, in situ cervical cancer, incidental prostatic cancer) • Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment • Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 3 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly). • Active participation in other clinical studies in the previous 4 weeks • Prior systemic therapy with cytostatics or immunotherapeutic agents • Concurrent use of other anticancer treatments after study commencement • Intravesical chemotherapy in the previous 4 weeks • Radiotherapy in the previous 4 weeks • Previous radiotherapy in which all lesions to be used for the evaluation of tumour response were irradiated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this explorative study is to assess the efficacy of the combination consisting of gemcitabine/cisplatin and panitumumab in patients with wild-type HRAS (non-mutated status). The progression-free survival rate at 12 months will be compared to expectations derived from historical data, which are verified by a randomised control group without the antibody.;Secondary Objective: •Determination of tumour response •Duration of response •Overall survival •Documentation of adverse effects •Quality of life survey ;Primary end point(s): Progression-free survival rate after 12 months. | — |
Countries
Germany
Outcome results
None listed