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

Sponsor
Lund University Hospital
Study ID
NCT01229813
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Oct 28, 2010
Start date
Oct 31, 2010
Status verified
Nov 2013
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
233 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: bevacizumab and erlotinib (KRAS WT)
  • Active Comparator: bevacizumab (KRAS WT)
  • Active Comparator: bevacizumab (KRAS mutated)
  • Active Comparator: low dose capecitabine (KRAS mutated)

Primary Outcome Measure

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 ]

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