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STEAM (SEQUENTIAL TRIPLET AND AVASTIN MAINTENANCE): FOLFOXIRI/BEVACIZUMAB REGIMENS (CONCURRENT AND SEQUENTIAL) VS. FOLFOX/BEVACIZUMAB IN FIRST-LINE METASTATIC COLORECTAL CANCER


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

STEAM (SEQUENTIAL TRIPLET AND AVASTIN MAINTENANCE): FOLFOXIRI/BEVACIZUMAB REGIMENS (CONCURRENT AND SEQUENTIAL) VS. FOLFOX/BEVACIZUMAB IN FIRST-LINE 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (ORR1) during first-line therapy, assessed by the investigator according to RECIST v.1.1 criteria

Outcome Time Frame:

approximately 5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

ML28442

NCT ID:

NCT01765582

Start Date:

January 2013

Completion Date:

December 2017

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Albany, Georgia  31701
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Omaha, Nebraska  68114
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Milwaukee, Wisconsin  
Lebanon, New Hampshire  
Tulsa, Oklahoma  
Jackson, Wyoming