Clinical trial NCT01374789 (phase 2, status: terminated)
Conditions: urinary bladder cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: gemcis + panitumumab, gemcis
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Reason stopped: 
    the study was terminated due to insufficient recruitment.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed, unresectable 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

          -  Serious inflammatory eye conditions, hearing impairment

          -  Pulmonary (pO2 < 60 mmHg), haemopoietic (e.g. serious bone marrow aplasia), hepatic or
             renal disorders

          -  Patients with poorly controlled diabetes mellitus

          -  Serious bacterial or fungal infections (>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

          -  Patients in a closed institution according to an authority or court decision