Skin toxicity treatment in patients with advanced or metastatic colorectal cancer (mCRC) and non-mutated (wild-type) KRAS treated with panitumumab monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Because of their frequency and severity panitumumab associated skin toxicities affect patients' quality of life and thus threaten patients' compliance to therapy. There is an urgent need for evidence-based treatment recommendations for the prevention and management of panitumumab -associated skin toxicities. The study aims to compare the efficacy and safety of a manageable preemptive treatment with oral doxycycline in combination with a supportive topical regimen containing erythromycin cream (2 %) over duration of 12 weeks on the occurrence and grade of panitumumab induced skin toxicities in a double-blind, controlled randomized setting. Basic skin treatment with or without doxycycline will be discontinued at the end of study treatment after 12 weeks or until a value of 6-10 is observed on the visual analogue scale (VAS), whichever is sooner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11
comparison of Doxycyline/Placebo and Panitumumab regarding efficacy of the therapy of panitumumab induced skin toxicity
mCRC patients receiving panitumumab as EGFR inhibitor.
DRK Kliniken Berlin / Köpenick, Klinik für Chirurgie
Berlin, Germany
Onkologische Schwerpunktpraxis
Berlin, Germany
Medizinisches Versorgungszentrum Ärzteforum Seestraße
Berlin, Germany
Time until unblinding of skin therapy allocation (basic skin treatment with or without doxycycline) due to insufficient efficacy (i.e. unbearable skin toxicity, measured by patient's allocating point 6 through 10 on a visual analogue scale)
Time frame: 30 month
Incidence of specific ≥ grade 2 skin toxicities over 12 weeks or until a value of 6-10 is observed on the VAS, whichever is sooner
Time frame: 30 months
Time to first occurrence of specific ≥ grade 2 skin toxicities
Time frame: 30 months
Most severe specific ≥ grade 3 skin toxicities of interest over 12 weeks or until a value of 6-10 is observed on the VAS, whichever is sooner
Time frame: 30 months
Time to the first most severe specific ≥ grade 3 skin toxicities
Time frame: 30 month
Incidence of panitumumab dose reduction due to the specific skin toxicities of interest over 12 weeks or until a value of 6-10 is observed on the VAS, whichever is sooner
Time frame: 30 month
Scores in DLQI under preemptive basic skin treatment with or without doxycycline
Time frame: 30month
Incidence of doxycycline related adverse events
Time frame: 30 month
Type of panitumumab related adverse events
Time frame: 30 month
Response rate to panitumumab over 12 weeks or until a value of 6-10 is observed on the VAS, whichever is sooner (only if patient received at least 8 weeks of study treatment)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Charité Campus Virchow Klinikum (CVK), Centrum für Tumormedizin, Medizinische Klinik mit Schwerpunkt Hämatologie u. Onkologie
Berlin, Germany
Ärzteforum Bernau
Bernau, Germany
Onkologische Schwerpunktpraxis
Brandenburg, Germany
Städtisches Klinikum Dessau, Hömatologie und Internistische Onkologie
Dessau, Germany
St. Georg Klinikum Eisenach gGmbH, Klinik für Innere Medizin 2
Eisenach, Germany
Krankenhaus St. Elisabeth u. St. Barbara, Klinik für Allgemein- u. Visceralchirurgie
Halle, Germany
Ärzteforum Hennigsdorf
Hennigsdorf, Germany
...and 2 more locations
Time frame: 30 month
Type of doxycycline related adverse events
Time frame: 30 month
Severity of doxycycline related adverse events
Time frame: 30 month
Incidence of panitumumab related adverse events
Time frame: 30 month
Severity of panitumumab related adverse events
Time frame: 30 month