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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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