West Cancer Center

COLORECTAL: Metastatic; 1st line: "STEAM"

STEAM: A study of sequential and concurrent FOLFOXIRI/Avastin (bevacizumab) regimens versus FOLFOX/Avastin in first-line in patients with metastatic colorectal cancer

Title

Hoffman-La Roche ML28442

Study Title

STEAM: A study of sequential and concurrent FOLFOXIRI/Avastin (bevacizumab) regimens versus FOLFOX/Avastin in first-line in patients with metastatic colorectal cancer

Site Link

NCT01765582

Malignancy

Colon, Rectal, Metastatic Colorectal

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st

Investigational Agent

Bevacizumab

Drug Class

Angiogenesis inhibitor

Brad Somer, MD

Sponsor

Hoffman-La Roche

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01765582?term=ML28442&rank=1

Key Eligibility Criteria Details

At least 1 measurable metastatic lesion
ECOG PS 0-1
Treated brain mets are allowed
No prior tx for metastatic CRC (prior radiosensitizers allowed)
At least 12 months after most recent adjuvant regimen
No clin significant nondrainableascites or pleural effusions
No uncontrolled hypertension
No clin significant cardiac disease

Objective

Primary- ORR, PFS: Secondary- ORR2 (during 2nd line), PFS2, time to PFS2, OS, liver resection rate, safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Colorectal

Dosing Frequency

IV q2 weeks; 4-6 month induction followed by maintenance and reinduction after disease progression

Control Agents

FOLFOX+Bev

Study Protocol

Randomized

Yes