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OpenTrials
Completed

NCT Number: NCT01229813

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital, Odense, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bevacizumab, erlotinib

Drug

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

Other names: Avastin, Tarceva

Bevacizumab

Drug

bevacizumab 7.5 mg/kg body weight every third week

Other names: Tarceva

low dose capecitabine

Drug

capecitabine 500 mg twice daily

Other names: Xeloda

Primary outcomes

  1. 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.

    Time frame: 3 years

Secondary outcomes

  1. To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumors.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Acronym: ACT2

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 28, 2010
Registry last updated
Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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