Safety assessment of treatment with cetuximab in metastatic colorectal cancer patients

ISRCTN ISRCTN34968597
DOI https://doi.org/10.1186/ISRCTN34968597
Secondary identifying numbers 01/08 at ARRS
Submission date
26/01/2010
Registration date
04/02/2010
Last edited
04/02/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Janja Ocvirk
Scientific

Zaloska 2
Ljubljana
1000
Slovenia

Phone +386 (0)15879221
Email jocvirk@onko-i.si

Study information

Study designSingle centre observational toxicity study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Scientific titleSafety assessment of treatment with cetuximab in metastatic colorectal cancer patients: An observational study
Study objectivesObservational 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(s)The National Medical Ethics Committee, Ministry of Health, Republic of Slovenia approved on the 26th of May 2009 (ref: 215/05/09)
Health condition(s) or problem(s) studiedMetastatic colorectal cancer
InterventionNon-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 typeOther
Primary outcome measure1. Safety of treatment with cetuximab
2. Management of skin toxicity of cetuximab
Secondary outcome measures1. Response rate (RECIST)
2. Progression- free survival (PFS)
3. Overall survival (OS)
Overall study start date01/06/2009
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsTotal of 250 patients
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/06/2009
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • Slovenia

Study participating centre

Zaloska 2
Ljubljana
1000
Slovenia

Sponsor information

Institute of Oncology Ljubljana (Slovenia)
Research organisation

Zaloska 2
Ljubljana
1000
Slovenia

Phone +386 (0)15879674
Email jocvirk@onko-i.si
ROR logo "ROR" https://ror.org/00y5zsg21

Funders

Funder type

Research organisation

Institute of Oncology Ljubljana (Slovenia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan