Avastin and chemotherapy followed by a KRAS stratified randomization to maintenance treatment for first line treatment of metastatic colorectal cancer
- Conditions
- Patients with previously untreated metastatic colorectal carcinoma.MedDRA version: 14.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-019815-40-SE
- Lead Sponsor
- Skåne University Hospital, Department of Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 230
1. Untreated metastatic colorectal carcinoma.
2. Age 18 years or more.
3. Measurable disease according to Response Evaluation Criteria in Solid Tumors
(RECIST) criteria.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
5. Life expectancy more than 3 months.
6. Adequate haematological, renal and liver function.
7. Tumor tissue available for determination of KRAS mutational status.
8. Blood sample and paraffin embedded tumor tissue for translational research.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130
1. Adjuvant therapy within 6 months.
2. Central nervous system (CNS) metastases.
3. Clinically significant atherosclerotic vascular disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression-free survival (PFS) rate at 3 months among patients without KRAS mutation as compared to maintenance treatment with bevacizumab alone.;Secondary Objective: To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumours.<br><br>To evaluate the efficacy in terms of progression free and overall survival.<br><br>To perform translational research for prognostic and treatment predictive markers.;Primary end point(s): To evaluate maintenance treatment with bevacizumab+erlotinib versus bevacizumab alone in patients with KRAS WT tumors following first line chemo- and anti-angiogenetic therapy by comparing progression-free survival rate at 3 months.;Timepoint(s) of evaluation of this end point: Every 9 weeks.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression-free survival (PFS) rate at 3 months among patients without KRAS mutation as compared to maintenance treatment with bevacizumab alone.;Timepoint(s) of evaluation of this end point: Every 9 weeks.