Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


Colorectal Cancer

FOLFOXIRI/Avastin Versus FOLFOX/Avastin for Metastatic Colorectal Cancer-STEAM (13010)
STEAM: (Sequential Triplet And Avastin Maintenance): Folfoxiri/Bevacizumab Regimens (Concurrent And Sequential) Vs. Folfox/Bevacizumab In First-Line Metastatic Colorectal Cancer
Status Conditions Phase Study ID
Recruiting Colorectal Cancer Phase II 13010
NCT01765582
Summary

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.


Investigator
Gabriela Chiorean, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • Any prior treatment for metastatic colorectal cancer, except for use of palliative radiosensitizers
  • Adjuvant chemotherapy for colorectal cancer completed < 12 months prior to study consent
  • Sensory peripheral neuropathy >/= grade 2
  • Evidence of Gilbert's Syndrome or homozygosity for the UGT1A1*28 allele
  • Positive for HIV infection
  • Malignancies other than metastatic colorectal cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
  • Radiotherapy to any site for any reason within 28 days prior to randomization, except for palliative radiotherapy to bone lesions within 14 days prior to randomization
  • Clinically significant third-space fluid collections (e.g. ascites or pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry
  • Treatment with any other investigational agent, or participation in an other investigational drug trial within 28 days prior to randomization
  • Pregnant or breastfeeding women
  • Any disease or condition or laboratory finding giving reasonable suspicion of disease or condition that contraindicates the use of bevacizumab or puts the patient at high risk for treatment-related complications
  • Inadequately controlled hypertension
  • Clinically significant (i.e. active) cardiovascular disease (e.g. cerebrovascular accident or myocardial infarction within 6 months prior to randomization), unstable angina, congestive heart failure (New York Heart Association Class >/= II) or serious cardiac arrhythmia that is uncontrolled by medication or may interfere with the administration of the study treatment
  • Known hypersensitivity to bevacizumab or any of its excipients or any other study drug
Last Updated
December 03, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.