Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of QoL in Patient With Kras-wt Colorectal Cancer
This study is currently recruiting participants.
Verified August 2012 by AIO-Studien-gGmbH
Sponsor:
AIO-Studien-gGmbH
Information provided by (Responsible Party):
AIO-Studien-gGmbH
ClinicalTrials.gov Identifier:
NCT01668498
First received: August 16, 2012
Last updated: August 17, 2012
Last verified: August 2012
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Purpose
80 - 90 % of the patients treated with anti-EGFR antibodies (panitumumab or cetuximab) experience skin toxicity, mostly acne like skin rash.
A standardized treatment of skin rash is neither established as standard arm for clinical trials nor as guideline for the treatment of skin toxicity in clinical practice. While an improvement of QoL has been demonstrated for panitumumab and cetuximab in comparison to best supportive care the data basis for patient related outcomes regarding skin toxicity deriving from randomized trials is still small.
Recent surveys among German oncologist revealed that physicians are reluctant to use oral antibiotics as preemptive treatment . Only 19 out of 110 oncologists stated that they are thinking about using preemptive treatment in patients with acne-like skin rash.
Thus, in the present trial two main questions will be addressed:
(i) Can preemptive treatment with oral doxycycline be replaced by a sequential skin treatment strategy (i.e. local treatment with erythromycin followed by doxycycline in case of inefficacy = development of acne) without compromising treatment efficacy of skin toxicity treatment? (ii) Comparison of general and skin related QoL between both treatment arms.
| Condition | Intervention | Phase |
|---|---|---|
|
Kras-wildtype Colorectal Cancer |
Drug: Erythromycin Drug: Doxycycline |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of Quality of Life in Patients With Kras-wildtype Colorectal Cancer |
Resource links provided by NLM:
Drug Information available for:
Erythromycin
Doxycycline
Erythromycin stearate
Erythromycin ethylsuccinate
Erythromycin phosphate
Doxycycline monohydrate
Doxycycline Hyclate
Doxycycline calcium
Panitumumab
U.S. FDA Resources
Further study details as provided by AIO-Studien-gGmbH:
Primary Outcome Measures:
- Percentage of patients developing no skin toxicity ≥ grade 2 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Percentage of patients developing no skin toxicity ≥ grade 2 at any time during their first 8-weeks of treatment with panitumumab.
Secondary Outcome Measures:
- Quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Quality of life will be assessed by standardized skin-related (DLQI) and global quality of life (EORTC QLQ C30.
For correlation analyses between the different quality of life scores, the non-parametric test according to Spearman will preferably be applied.
- Assess Skin toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Assess different skin toxicity grading scales (i.e. NCI CTC v. 4.0; WoMo score; MESTT)
- Correlation between skin-related and global quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Description of correlation between skin-related and global quality of life using EORTC-QLQ C30 and SF-36.
- late skin toxicity [ Time Frame: from week 8 to 12 ] [ Designated as safety issue: Yes ]Describe the development of late skin toxicity after 8 weeks
- Skin-toxicity related dose reductions of panitumumab [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Rate of skin-toxicity induced dose reductions (including withdrawal) of panitumumab
| Estimated Enrollment: | 74 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Erythromycin
Experimental Arm (ARM A) skin- treatment: erythromycin cream 2% daily at bedtime doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2 skin moisturizer daily at morning, sunscreen before going outdoors for 8 weeks
|
Drug: Erythromycin
Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (kras wild-type)being treated with panitumumab.
Other Name: Aknemycin
|
|
Active Comparator: Doxycyline
Standard Arm (ARM B) skin- treatment:doxycycline 100mg b.i.d. skin moisturizer daily at morning, sunscreen before going outdoors for 8 weeks
|
Drug: Doxycycline
Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (kras wild-type)being treated with panitumumab.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with wild-type KRAS status of metastatic colorectal cancer treatment with panitumumab according to label
- treatment with pre-emptive study medication shall begin the day before treatment start with panitumumab
- Willingness to cope with biweekly quality of life questionnaires
- Written Informed consent
- Aged at least 18 years
- ECOG Performance Status 0-2
- Life expectancy of at least 12 weeks
Adequate haematological, hepatic, renal and metabolic function parameters:
- Leukocytes > 3000/mm³
- ANC ≥ 1500/mm³
- Platelets ≥ 100,000/mm³
- Haemoglobin > 9 g/dl
- Serum creatinine ≤ 1.5 x ULN
- Bilirubin ≤ 1.5 x ULN
- GOT-GPT ≤ 2.5 x ULN (in case of liver metastases GOT / GPT ≤ 5 x ULN)
- AP ≤ 5 x ULN
- Magnesium, Calcium and potassium within normal ranges (may be substituted before study entry)
Exclusion criteria:
- 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 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
- Serious concurrent diseases
- On-treatment participation in a clinical study in the period 30 days prior to inclusion
- Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment.
- History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- History of HIV infection.
- 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
- Known allergic reactions on panitumumab, doxycycline or erythromycin
- Previous treatment with anti-cancer agents directed against EGFR (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib)
- Skin rash existing before or due to other reasons than panitumumab treatment
- Other dermatologic disease that may interfere with correct grading of panitumumab induced skin rash
- Parallel treatment with anti-tumor agents other than panitumumab
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668498
Contacts
| Contact: Karin Krause, B.Sc. | +49 - 30 - 322932932 | krause@aio-portal.de |
Locations
| Germany | |
| Universitätsklinikum Mannheim, III. Medizinische Klinik | Recruiting |
| Mannheim, Germany, 68167 | |
| Contact: Melanie Kripp, Dr. +49621383 ext 2855 melanie.kripp@umm.de | |
Sponsors and Collaborators
AIO-Studien-gGmbH
Investigators
| Principal Investigator: | Melanie Kripp, Dr. med. | III. Medizinische Klinik, Universitätsmedizin Mannheim |
More Information
Additional Information:
No publications provided
| Responsible Party: | AIO-Studien-gGmbH |
| ClinicalTrials.gov Identifier: | NCT01668498 History of Changes |
| Other Study ID Numbers: | AIO-LQ-0110, 2010-022938-85 |
| Study First Received: | August 16, 2012 |
| Last Updated: | August 17, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by AIO-Studien-gGmbH:
|
Can preemptive treatment of panitumumab mediated skin toxicity with oral doxycycline be replaced by local treatment with erythromycin? Panitumumab |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Doxycycline Doxycycline hyclate Erythromycin |
Erythromycin Estolate Erythromycin Ethylsuccinate Erythromycin stearate Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents Gastrointestinal Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013