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STEAM (Sequencing Triplet with Avastin and Maintenance): Folfoxiri/Bevacizumab Regiments (Concurrent and Sequential) vs. Folfox/Bevacizumab in First-Line Metastatic Colorectal Cancer

Conditions

Colon

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

This randomized, open-label, multicenter study will evaluate the efficacy and safety of FOLFOXIRI/Avastin (bevacizumab) regimens (concurrent and sequential) versus FOLFOX/Avastin in first-line in patients with metastatic colorectal cancer. Patients will be randomized to receive Avastin 5 mg/kg intravenously every 2 weeks with either concurrent or sequential FOLFOXIRI or with FOLFOX for 4 to 6 months of induction therapy, followed by maintenance therapy with Avastin plus either leucovorin/5-fluorouracil or capecitabine until disease progression occurs. After disease progression, patients will receive treatment with a fluoropyrimidine-based chemotherapy plus Avastin.


Participation Guidelines

Age:
18 Years - 75 Years
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 and
  • Histologically confirmed colorectal cancer with at least one measurable metastatic lesion by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematological, renal and liver function
  • Patients with treated brain metastases are eligible for study participation patients may not receive ongoing treatment with steroids at screening, anticonvulsants (at stable dose) are allowed
  • Females of childbearing potential and males must agree to use effective contraception as defined by protocol during the treatment period and for at least 6 months after the last dose of study drug
Sponsor:
Hoffman-La Roche
Dates:
07/30/2013
Last Updated:
Study HIC#:
1302011576