Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01229813

Acronym

ACT2

Enrollment

233

Registered

2010-10-28

Start date

2010-10-31

Completion date

2013-12-31

Last updated

2015-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Untreated, First line, Chemotherapy, Maintenance treatment, KRAS wt, KRAS mutated, Anti-angiogenetic treatment, Metronomic capecitabine, bevacizumab, erlotinib, Translational research

Brief 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.

Interventions

DRUGbevacizumab, erlotinib

bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily

DRUGbevacizumab

bevacizumab 7.5 mg/kg body weight every third week

DRUGlow dose capecitabine

capecitabine 500 mg twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	3 years

Secondary

Measure	Time frame
To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumors.	3 years

Countries

Denmark, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026