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Ras-wildtype Colorectal CancerPhase 2NCT01668498

Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of QoL in Patient With Ras-wt Colorectal Cancer

A Phase 2 study testing Erythromycin and Doxycycline in people with Ras-wildtype Colorectal Cancer, run by AIO-Studien-gGmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ras-wildtype Colorectal Cancer
What is being tested?
Erythromycin and Doxycycline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteGermany
Study dates
May 2011to Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • NRAS exon 3 (codons 59/61)
  • NRAS exon 4 (codons 117/146)
  • 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)

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsklinikum Mannheim, III. Medizinische Klinik

    Mannheim, 68167

Other trials in Germany

About this study

Official title: Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of Quality of Life in Patients With Ras-wildtype Colorectal Cancer

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.

Read more

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.

Being tested
Erythromycin, Doxycycline
Keywords
Can preemptive treatment of panitumumab mediated skin, toxicity with oral doxycycline be replaced by local treatment with erythromycin?, Panitumumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErythromycinDrug

    Also called Aknemycin

    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 (Ras wild-type)being treated with panitumumab.

  • DoxycyclineDrug

    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 (Ras wild-type)being treated with panitumumab.

Study groups in NCT01668498
Study groupRoleWhat they receive
ErythromycinExperimentalExperimental 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
Receives: Drug: Erythromycin
DoxycylineActive comparatorStandard Arm (ARM B) skin- treatment:doxycycline 100mg b.i.d. skin moisturizer daily at morning, sunscreen before going outdoors for 8 weeks
Receives: Drug: Doxycycline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients developing no skin toxicity ≥ grade 2

    Percentage of patients developing no skin toxicity ≥ grade 2 at any time during their first 8-weeks of treatment with panitumumab.

    Measured: 8 weeks

Secondary outcomes (5)

  1. Quality of life

    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.

    Measured: 8 weeks

  2. Assess Skin toxicity

    Assess different skin toxicity grading scales (i.e. NCI CTC v. 4.0; WoMo score; MESTT)

    Measured: 8 weeks

  3. Correlation between skin-related and global quality of life

    Description of correlation between skin-related and global quality of life using EORTC-QLQ C30 and SF-36.

    Measured: 8 weeks

  4. late skin toxicity

    Describe the development of late skin toxicity after 8 weeks

    Measured: from week 8 to 12

  5. Skin-toxicity related dose reductions of panitumumab

    Rate of skin-toxicity induced dose reductions (including withdrawal) of panitumumab

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2012 (estimated)
  2. Study startMay 2011
  3. Primary completionJan 2015
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01668498
Sponsor's protocol ID
AIO-LQ-0110
Other IDs
2010-022938-85
Status last verified
Apr 2016
First submitted
16 Aug 2012
Last updated
19 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erythromycin and Doxycycline in people with Ras-wildtype Colorectal Cancer, run by AIO-Studien-gGmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients developing no skin toxicity ≥ grade 2 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01668498.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.

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