Trial document




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  DRKS00000163

Trial Description

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Title

Feasibility of extracorporeal elimination of liposomal chemotherapeutics by double membrane plasmapheresis

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Trial Acronym

CARL-Studie

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URL of the Trial

http://keine

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Brief Summary in Lay Language

CARL: Controlled Applikation and Removal of Liposomal therapeutics and diagnostics
Using highly toxic drugs like chemotherapeutic agents, therapeutic success is often limited by severe adverse effects. For example, the use of doxorubicin is restricted by severe cardio toxicity. To lower the acute and chronic cardio toxicity of doxorubicin, long circulating liposomes (e.g. DOXIL®/CAELYX®) can be used as drug delivery systems. Thereby the toxic profile of the encapsulated doxorubicin is shifted, but detoxification of drugs not reaching the tumor still remains an obstacle. Nanoscale particle based drug delivery systems like liposomes accumulate to some extent in tumor tissues, but still only a very small portion of the given dose reaches the target tissue. Accumulation within the tumor takes several hours, and when accumulation is completed, still a main portion of the administered chemotherapeutic agent is circulating in the plasma. Finding a way to eliminate this portion will lower the patients burden of toxic agent and may diminish severe adverse effects during chemotherapy.
In some respects, liposomes are very similar to low-density-lipoproteins (LDL). LDL can be efficiently eliminated by LDL-apheresis-systems. LDL-apheresis is an extracorporeal technique, like dialysis. This technique is used for years in clinical practice.
DOXIL®/CAELYX®, the most common liposomal chemotherapeutic agent, can be eliminated by an adapted plasmapheresis treatment.
In general, CARL aims to reduce the severe adverse effects during chemotherapy. Within this first study, the efficacy and safety of extracorporeal elimination of liposomal chemotherapeutics is investigated.

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Brief Summary in Scientific Language

Test Plan:
Day 1: 25 mg/m2 Navelbine
Day 8: 25 mg/m2 Navelbine
Day 15: 40 mg/m2 Caelyx
Day 17: Plasmapheresis (3l plasma volume)

4 cycles, 3 weeks each, are conducted.
After 2 cycles tumor size is evaluated by ultrasound. The treatment is stopped if no response is seen.
The treatment is neoadjuvant.

Plasmapheresis is done by double membrane filtration. To evaluate safety and efficiency the doxorubicin concentration is measured prior to plasmapheresis and during plasmapheresis in different circuits of the machinery.

Within the amandment (recruiting) the influence of plasmapheresis on the pharmacokinetics of liposomal doxorubicin is investigated.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00000163
  •   2009/07/15
  •   2007/10/19
  •   yes
  •   Approved
  •   171/07, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   UKF001259  (Register Klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   Day 1 Navelbine 25 mg/m2 i.v.
    Day 8 Navelbine 25 mg/m2 i.v
    Day 15 Caelyx 40 mg/m2 i.v.
    Day 17 Plasmapherese (Membranfiltration) 3l Plasmavolumen

    4q3 wks

    or

    day 1 50 mg/m2 Caelyx, day 3 Plasmapheresis, q4weeks
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
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  •   [---]*
  •   N/A
  •   [---]*
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Primary Outcome

Efficacy and safety of extracorporeal elimination of liposomal chemotherapeutics by double membrane plasmapheresis

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Secondary Outcome

Occurence of main severe side effects (PPE, Stomatitis, Neutropenia)
quality of life

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/06/23
  •   21
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

-primary breast cancer
-age 18<x<60
-ECOG performance status <2
-secure vein access for apheresis catheter possible

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Exclusion Criteria

-Creatinin clearance <20 ml/min, severe hepatic disorder
-coronary heart disease, heart insufficiency >=NYHA II
-Hemoglobin < 10 g/dl; neutrophiles < 1500/µl; thrombocytes < 100.000/µl
-allergic reaction to navelbine, doxorubicin, liposomal doxorubicin, heparin
-skin disease
-BMI < 20
-pregnancy
-prior treatment with Doxil/Caelyx
-regular extracorporeal treatments
-treatment with ACE-inhibitors or AT-1- receptorantagonists

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg Abt. Klinische Chemie
    • Mr.  Dr. rer. nat.  Gerhard  Pütz 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg Abt. Hämatologie und Onkologie
    • Mr.  Dr. med.  Oliver  Schmah 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/02/08
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Trial Publications, Results and other Documents

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