Individualised choise of 1.line chemotherapy of metastatic colo-rectal cancer. Can the blood test: TIMP-1 help the doctor to choose the best chemotherapy for the individual patient?
- Conditions
- Metastatic colon or rectal cancerMedDRA version: 14.1Level: PTClassification code 10027457Term: Metastases to liverSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-005495-42-DK
- Lead Sponsor
- Kell Osterlind
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 210
Histologically proven colon or rectal cancer
Metastatic disease primary (stage IV) or due to relapse of previous (resected) stage I-III disease
At least 1 measurable lesion
18 years of age or older
WHO performance status <3
Expected survival >3 months
Hgb>6.1 mmol/L, WBC>2.9, platelets>99
Kidney and liver function tests below certain defined upper limits
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
Previous chemotherapy (including adjuvant after primary surgery)
Previous cancer (except non melanoma skin cancer)
Allergy to any of the therapeutical substances
Neuropathy (e.g. alcoholic or diabetic)
Recent myocardial infarction or stroke
Uncontrollable hypertension
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Progression free survival (PFS);Timepoint(s) of evaluation of this end point: CT scan every 9 weeks. Endpoint achieved at CT scan proving progression;Main Objective: Aim is to investigate whether or not the cancer marker plasma TIMP-1 is related to probability of treatment response on chemotherapy with or without irinotecan;Secondary Objective: To investigate if addition of bevacizumab day 22 has specific impact on the initial effect of the chemotherapy as reflected in changes in plasma TIMP-1 and two other markers
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Sequence of plasma TIMP-1 values days 0, 21, 42 and 63;Timepoint(s) of evaluation of this end point: Please se former cell