STEAM: A Study of Sequential and Concurrent FOLFOXIRI/Avastin (Bevacizumab) Regimens Versus FOLFOX/Avastin in First-Line in Patients With Metastatic Colorectal Cancer

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

Exclusion Criteria:

- 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