patients with muscle invasive transitional cell carcinoma of the bladder MedDRA version: 12.1 Level: LLT Classification code 10005017 Term: Bladder carcinoma stage 0, with cancer in situ MedDRA version: 12.1 Level: LLT Classification code 10005019 Term: Bladder carcinoma stage I, with cancer in situ MedDRA version: 12.1 Level: LLT Classification code 10005021 Term: Bladder carcinoma stage II
Conditions
Interventions
Product Name: panitumumab
Product Code: AMG954
Pharmaceutical Form: Solution for infusion
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Signed written informed consent. Histologically confirmed bladder carcinoma stage (including previous treatment): T2 N0 M0, refusing surgery and not eligible for brachytherapy T3-4a N0 M0 T1-4a pN1 M0: with no evidence of lymphnode disease as assessed by CT-scan and pN1 before neoadjuvant chemotherapy as assessed by lymphadenectomy. CR or PR following neoadjuvant chemotherapy as assessed by CT-scan. T1-4a N1-2 M0 with evidence of lymphnode disease prior to chemotherapy as assessed by CT-scan and pN0-1 after neoadjuvant chemotherapy as assessed by lymphadenectomy. a Karnofsky performance of more or equl 70 prior to chemotherapy and prior to combined Panitumumab/radiotherapy treatment. Hematopoietic function: Neutrophils = 1.5 x 109/L, platelets = 100 x 109/L, leucocytes> 3,000/mm3 and hemoglobin = 9 g/dL. Hepatic function: Total bilirubin = 1.5 times the upper normal limit (UNL), ASAT = 2.5 x UNL and ALAT = 2.5 x UNL. Renal function: Creatinin clearance = 50 mL/min (calculated clearance). Metabolic function: Magnesium = lower limit of normal and Calcium = lower limit of normal. Adequate follow-up possibilities for at least two years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Evidence of M+ (all patients will undergo a pelvic lymphadenectomy prior to chemoradiation). Prior chemotherapy or radiotherapy to the pelvis. Prior treatment with anti EGFr and/or anti VEGF treatment. Previous malignancy except skin carcinoma (basal cell and squamous cell carcinoma). Candidate for brachytherapy. No adequate bladder function (functional capacity 1/h). Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ? 1 year before enrollment/randomization. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. 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 6 months (male or female) after the end of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to evaluate the safety of combined radiotherapy with Panitumumab in bladder preservation in invasive bladder cancer. ;Secondary Objective: Secondary objectives are to investigate the efficacy of combined radiotherapy with Panitumumab in bladder preservation in invasive bladder cancer. ;Primary end point(s): Acute Toxicity rate during radiotherapy with Panitumumab treatment | — |
Countries
Netherlands
Outcome results
None listed