Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.
Information source: Lund University Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Cancer
Intervention: bevacizumab, erlotinib (Drug); bevacizumab (Drug); bevacizumab (Drug); low dose capecitabine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Lund University Hospital
Summary
Patients with metastatic colorectal cancer will be treated with chemotherapy according to
investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will
be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the
patients KRAS status will be tested. After having fulfilled these 18 weeks of induction
treatment, patients who has responded (complete response/partial response versus stable
disease) will be randomized to maintenance treatment. Patients with KRAS WT will be
randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS
mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational
research is performed, with purpose to find predictive factors in blood and tumor tissue.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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) compared to treatment with only bevacizumab.
Secondary outcome: To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumors.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Untreated metastatic colorectal carcinoma
- Age 18 yrs or over
- Measurable disease according to Response Evaluation Criteria in solid Tumors
(RECIST criteria)
- ECOG performance status 0 or 1
- Life expectancy more than 3 months
- Adequate haematological, renal and liver function
- Tumor tissue available for determination of KRAS mutational status
- Blood sample and paraffin embedded tumor tissue for translational research
Exclusion Criteria:
- Adjuvant therapy within 6 months
- CNS metastases
- Clinically significant atherosclerotic vascular disease
Locations and Contacts
University Hospital, Odense, Denmark
County Hospital Ryhov, Jönköping, Sweden
County Hospital, Kalmar, Sweden
Central Hospital, Karlstad, Sweden
University Hospital, Linköping, Sweden
Skåne University Hospital-Lund, Lund 221 85, Sweden
Karolinska University Hospital, Stockholm, Sweden
Sundsvall Hospital, Sundsvall, Sweden
Norrland University Hospital, Umeå, Sweden
Akademiska Hospital, Uppsala, Sweden
Central Hospital, Västerås, Sweden
Central Hospital, Växjö, Sweden
Additional Information
Starting date: October 2010
Last updated: April 10, 2015
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