Working… Menu
Trial record 51 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer. (ACT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01229813
Recruitment Status : Completed
First Posted : October 28, 2010
Last Update Posted : April 13, 2015
Hoffmann-La Roche
Information provided by (Responsible Party):
Lund University Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: bevacizumab, erlotinib Drug: bevacizumab Drug: low dose capecitabine Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: bevacizumab and erlotinib (KRAS WT) Drug: bevacizumab, erlotinib
bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily
Other Name: Avastin, Tarceva

Active Comparator: bevacizumab (KRAS WT) Drug: bevacizumab
bevacizumab 7.5 mg/kg body weight every third week
Other Name: Tarceva

Active Comparator: bevacizumab (KRAS mutated) Drug: bevacizumab
bevacizumab 7.5 mg/kg body weight every third week.
Other Name: Avastin

Active Comparator: low dose capecitabine (KRAS mutated) Drug: low dose capecitabine
capecitabine 500 mg twice daily
Other Name: Xeloda

Primary Outcome Measures :
  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 Outcome Measures :
  1. To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumors. [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01229813

Layout table for location information
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, Sweden, 221 85
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
Sponsors and Collaborators
Lund University Hospital
Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Lund University Hospital Identifier: NCT01229813     History of Changes
Other Study ID Numbers: ML 25359
First Posted: October 28, 2010    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: November 2013
Keywords provided by Lund University Hospital:
Metronomic capecitabine
First line
Maintenance treatment
KRAS mutated
Anti-angiogenetic treatment
Translational research
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Erlotinib Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors