Condition category
Cancer
Date applied
26/01/2010
Date assigned
04/02/2010
Last edited
04/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Janja Ocvirk

ORCID ID

Contact details

Zaloska 2
Ljubljana
1000
Slovenia
+386 (0)15879221
jocvirk@onko-i.si

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01/08 at ARRS

Study information

Scientific title

Safety assessment of treatment with cetuximab in metastatic colorectal cancer patients: An observational study

Acronym

Study hypothesis

Observational study, recording skin toxicity of cetuximab according to the National Cancer Institute Common Toxicity Criteria (NCI CTC), version 3.0, and to determine the best management of skin toxicity of cetuximab

Ethics approval

The National Medical Ethics Committee, Ministry of Health, Republic of Slovenia approved on the 26th of May 2009 (ref: 215/05/09)

Study design

Single centre observational toxicity study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Metastatic colorectal cancer

Intervention

Non-interventional, observational study
Patients with metastatic colorectal cancer will be treated with standard chemotherapy in combination with cetuximab, with loading dose of 400 mg/m2 and following weekly dose of 250 mg/m2 6 months and then according to RECIST criteria for response with maintenance therapy with cetuximab until progression of disease, unacceptable toxicity or the patient refuses further treatment. During the treatment skin toxicity of cetuximab- acneiform rash, nail changes, hypertrichosis, teleangiectasias, pruritus, paronychia, will be recorded according the National Cancer Institute Common Toxicity Criteria (NCI CTC), version 3.0.
Assessments will be performed at baseline, every week during weekly cetuximab therapy, every two weeks during maintenance therapy with cetuximab, during follow up every 3 months until the progression of disease.
The total duration of follow up will be 3 years

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Safety of treatment with cetuximab
2. Management of skin toxicity of cetuximab

Secondary outcome measures

1. Response rate (RECIST)
2. Progression- free survival (PFS)
3. Overall survival (OS)

Overall trial start date

01/06/2009

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent
2. Histologically confirmed colorectal cancer
3. Diagnosis of metastatic disease
4. Age 18 to 75 years
5. ECOG performance score 0- 2
6. Life expectancy of at least 3 months
7. Adequate haematological function (ANC ≥1.5 x 10/9L, platelets ≥ 100 x 10/9/L, Hb ≥ 90g/L)
8. Adequate liver function (serum bilirubin ≤ 1.5 x ULN, AST/ALP ≤ 2.5 x ULN, in case of liver metastases < 5 x ULN)
9. Adequate renal function (calculated creatinine clearance ≥ 50 mL/min)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Total of 250 patients

Participant exclusion criteria

1. ECOG performance score > 2
2. Prior treatment with cetuximab
3. Participation in another clinical trial within 30 days prior to entering this study
4. Known hypersensitivity to any of the study drugs
5. Clinically significant cardiovascular disease
5.1. Myocardial infarction ≤ 6 months before treatment start
5.2. Unstable angina
5.3. Uncontrolled hypertension
5.4. Arrhythmia requiring medication
5. Clinical evidence or confirmed brain metastases
6. Psychiatric disability to be clinically significant precluding informed consent
7. Evidence of any other disease, metabolic dysfunction or laboratory findings, which give a suspicion of a disease or condition that contraindicates the use of any investigational drugs or means a higher risk for treatment-related complications

Recruitment start date

01/06/2009

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Slovenia

Trial participating centre

Zaloska 2
Ljubljana
1000
Slovenia

Sponsor information

Organisation

Institute of Oncology Ljubljana (Slovenia)

Sponsor details

Zaloska 2
Ljubljana
1000
Slovenia
+386 (0)15879674
jocvirk@onko-i.si

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Institute of Oncology Ljubljana (Slovenia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes