Panitumumab-mediated Skin toxicity in palliative treatment of Metastatic colorectal cancer with panitumumab
Conditions
Interventions
Trade Name: Aknemycin
Product Name: Erythromycin
Pharmaceutical Form: Ointment
INN or Proposed INN: Erythromycin
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentrati
Sponsors
AIO-Studien-gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with wild-type RAS (KRAS and NRAS) status of metastatic colorectal cancer treatment with panitumumab according to label ? RAS wild-type tested in ? KRAS exon 2 (codons 12/13) ? KRAS exon 3 (codons 59/61) ? KRAS exon 4 (codons 117/146) ? NRAS exon 2 (codons 12/13) ? NRAS exon 3 (codons 59/61) ? NRAS exon 4 (codons 117/146) 2. Treatment with pre-emptive study medication shall begin the day before treatment start with panitumumab 3. Willingness to cope with biweekly quality of life questionnaires 4. Written Informed consent 5. Aged at least 18 years 6. ECOG Performance Status 0-2 7. Life expectancy of at least 12 weeks 8. Adequate haematological, hepatic, renal and metabolic function parameters: i. Leukocytes > 3000/mm³ ii. ANC = 1500/mm³ iii. Platelets = 100,000/mm³ iv. Haemoglobin > 9 g/dl v. Serum creatinine = 1.5 x ULN vi. Bilirubine = 1.5 x ULN vii. GOT-GPT = 2.5 x ULN (in case of liver metastases GOT / GPT = 5 x ULN) viii. AP = 5 x ULN ix. Magnesium, Calcium and potassium within normal ranges (may be substituted before study entry) 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. 2. 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 (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly). 3. Serious concurrent diseases 4. On-treatment participation in a clinical study in the period 30 days prior to inclusion 5. Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrolment. 6. History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. 7. History of HIV infection. 8. Other previous or concurrent malignancy (= 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free 9. Known allergic reactions on panitumumab, doxycycline or erythromycin 10. Previous treatment with anti-cancer agents directed against EGFR (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) 11. Skin rash existing before or due to other reasons than panitumumab treatment 12. Other dermatologic disease that may interfere with correct grading of panitumumab induced skin rash 13. Parallel treatment with anti-tumor agents other than panitumumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Percentage of patients developing no skin toxicity = grade 2 at any time during their first 8-weeks of treatment with panitumumab;Secondary Objective: -Evaluate skin-related (DLQI) and global quality of life (EORTC QLQ C30) -Assess different skin toxicity grading scales (i.e. NCI CTC v. 4.0; WoMo score; MESTT) -Describe the correlation between skin-related and global quality of life using EORTC-QLQ C30 and SF-36 -Describe the development of late skin toxicity after 8 weeks -Rate of skin-toxicity induced dose reductions (including withdrawal) of panitumumab ;Primary end point(s): Percentage of patients developing no skin toxicity = grade 2 at any time during their first 8-weeks of treatment with panitumumab;Timepoint(s) of evaluation of this end point: The main biostatistical evaluation of the study and the compilation of the statistical report as part of the integrated clinical/biometrical report will be performed six months after termination of patient recruitment and follow-up as well as after completion and/or correction of all case report forms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Evaluate skin-related (DLQI) and global quality of life (EORTC QLQ C30) •Assessment different skin toxicity grading scales (i.e. NCI CTC v. 4.0; WoMo score; MESTT) •Describe the correlation between skin-related and global quality of life using EORTC-QLQ C30 and SF-36. •Describe the development of late skin toxicity after 8 weeks •Rate of skin-toxicity induced dose reductions (including withdrawal) of panitumumab;Timepoint(s) of evaluation of this end point: The main biostatistical evaluation of the study and the compilation of the statistical report as part of the integrated clinical/biometrical report will be performed six months after termination of patient recruitment and follow-up as well as after completion and/or correction of all case report forms. | — |
Countries
Germany
Outcome results
None listed