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

Colorectal Cancer Clinical Trial

— ACT2  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229813
• Other study ID #: ML 25359
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2010
• Last updated: April 10, 2015
• Start date: October 2010
• Est. completion date: December 2013

Study information

• Verified date: November 2013
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• bevacizumab, erlotinib
bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily
• bevacizumab
bevacizumab 7.5 mg/kg body weight every third week
• bevacizumab
bevacizumab 7.5 mg/kg body weight every third week.
• low dose capecitabine
capecitabine 500 mg twice daily

Locations

Country	Name	City	State
Denmark	University Hospital	Odense
Sweden	County Hospital Ryhov	Jönköping
Sweden	County Hospital	Kalmar
Sweden	Central Hospital	Karlstad
Sweden	University Hospital	Linköping
Sweden	Skåne University Hospital-Lund	Lund
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

Sponsors (2)

Lead Sponsor	Collaborator
Lund University Hospital	Hoffmann-La Roche

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumors.		3 years	Yes