Trial document




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  DRKS00003516

Trial Description

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Title

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 - AB 23/09

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Trial Acronym

PURO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The efficacy of chemotherapy for bladder cancer will be evaluated by standard therapy in combination with a receptor-antibody (Panitumumab). The study-aim is the progression-free survival rate after 12 months. Patients be included in the study who have a transitional cell carcinoma of the bladder or upper urinary tract.

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Brief Summary in Scientific Language

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

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Organizational Data

  •   DRKS00003516
  •   2012/04/30
  •   2011/03/30
  •   yes
  •   Approved
  •   10/045-ZS EK 10 , Ethik-Kommission des Landes Berlin
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Secondary IDs

  •   2009-015119-42 
  •   NCT01374789  (ClinicalTrials.gov)
  •   1032/01 
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Health Condition or Problem studied

  •   bladder cancer
  •   C67 -  Malignant neoplasm of bladder
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Interventions/Observational Groups

  •   Gemcitabine: 1250 mg/m², intravenous, on day 1 and 8 of each three-week cycle

    Cisplatin: 70 mg/m², intravenous, on day 2 of each three-week cycle

    Panitumumab (Vectibix): 9 mg/kg body weight, intravenous , on day 1 of each three-week cycle

    info: max. 6 cycles

  •   Gemcitabine: 1250 mg/m², intravenous, on day 1 and 8 of each three-week cycle

    Cisplatin: 70 mg/m², intravenous, on day 2 of each three-week cycle

    info: max. 6 cycles

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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   II
  •   Yes
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Primary Outcome

Progression-free survival rate after 12 months.

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Secondary Outcome

- Determination of best response (CR, PR and SD) rates in accordance with the RECIST criteria [ Time Frame: up to 18 weeks (until the end of treatment) ]
- Duration of response, progression-free and overall survival time [ Time Frame: 2 years (until the end of follow up) ]
- Documentation of adverse effects in accordance with the NCI CTC criteria [ Time Frame: up to 18 weeks (until the end of treatment) ]
- Documentation of quality of life on the basis of the EORTC questionnaire [ Time Frame: up to 18 weeks (until the end of treatment) ]

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/04/19
  •   124
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional 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

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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

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Addresses

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    • GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
    • Alexanderplatz 1
    • 10178  Berlin
    • Germany
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    •   030 / 27876089-0
    •   030 / 27876089-18 oder -17
    •   [---]*
    •   [---]*
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    • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
    • Mr.  Prof. Dr. med.  Kurt  Miller 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
    • Mr.  Prof. Dr. med.  Kurt  Miller 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • AMGEN GmbH
    • Hanauer Str. 1
    • 80992  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.