ACT (ML 19033). A Nordic collaborative study
Titel Avastin and Chemotherapy followed by Avastin alone or in combination with Tarceva for the treatment of metastatic colorectal cancer.
Akronym ACT (ML 19033)
Typ av studie Multicenter, multinational, randomized, open label comparative phase III study
Sponsor Dept of Oncology, Lund University Hospital
Inklusionskriterier
  • Age ≥18 years
  • Untreated metastatic colorectal carcinoma
  • Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST) criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy more than 3 months
  • Adequate hematological, renal and liver function
  • Blood sample and paraffin embedded tumor tissue for translational research.
Studiedesign



Bevacizumab 7.5 mg/kg d1 q3w + erlotinib 150 mg qd

Bevacizumab 7.5 mg/kg d1 q3w alone continuosly until treatment failure

Endpoint(s)

To demonstrate that maintenance treatment with bevacizumab + erlotinib following 1st line chemo- and anti-angiogenic therapy results in a significant increase in progression-free survival (PFS) compared to maintenance treatment with bevacizumab alone.

Rekryteringsperiod 2006 - 2009
Antal inkluderade patienter 240 patients will be recruited
Publikationer

 
   
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Uppdaterad: 2008 02 20