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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT01229813
First received: October 27, 2010
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: bevacizumab, erlotinib
Drug: bevacizumab
Drug: low dose capecitabine
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Lund University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumors. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 181
Study Start Date: October 2010
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229813

Locations
Denmark
University Hospital
Odense, Denmark
Sweden
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
  More Information

No publications provided

Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT01229813     History of Changes
Other Study ID Numbers: ML 25359
Study First Received: October 27, 2010
Last Updated: November 27, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Lund University Hospital:
Untreated
First line
Chemotherapy
Maintenance treatment
KRAS wt
KRAS mutated
Anti-angiogenetic treatment
Metronomic capecitabine
bevacizumab
erlotinib
Translational research

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Capecitabine
Erlotinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014