We're sorry, but this trial is no longer enrolling volunteers.
STEAM (SEQUENTIAL TRIPLET AND AVASTIN MAINTENANCE): FOLFOXIRI/BEVACIZUMAB REGIMENS (CONCURRENT AND SEQUENTIAL) VS. FOLFOX/BEVACIZUMAB IN FIRST-LINE METASTATIC COLORECTAL CANCER
Description
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.
Inclusion and Exclusion 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
- 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
Sites
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California
- Unknown facility, Long Beach, California, 90806
- Unknown facility, Long Beach, California, 90806
- Unknown facility, Salinas, California, 93901
- Unknown facility, Salinas, California, 93901
- Unknown facility, Monterey, California, 93940
- Unknown facility, Monterey, California, 93940
- Unknown facility, Sacramento, California, 95816
- Unknown facility, Sacramento, California, 95816
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Colorado
- Unknown facility, Denver, Colorado, 80205
- Unknown facility, Denver, Colorado, 80205
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Wyoming
- Unknown facility, Cheyenne, Wyoming, 82001
- Unknown facility, Cheyenne, Wyoming, 82001
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Washington
- Unknown facility, Spokane, Washington, 99208
- Unknown facility, Spokane, Washington, 99208
- Unknown facility, Seattle, Washington, 98109
- Unknown facility, Seattle, Washington, 98109
- Unknown facility, Kirkland, Washington, 98034
- Unknown facility, Kirkland, Washington, 98034
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Oklahoma
- Unknown facility, Oklahoma City, Oklahoma, 73104
- Unknown facility, Oklahoma City, Oklahoma, 73104
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Texas
- Unknown facility, Fort Worth, Texas, 76104
- Unknown facility, Temple, Texas, 76508
- Unknown facility, Temple, Texas, 76508
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Nebraska
- Unknown facility, Lincoln, Nebraska, 68510
- Unknown facility, Omaha, Nebraska, 68114
- Unknown facility, Omaha, Nebraska, 68114
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Missouri
- Unknown facility, St. Louis, Missouri, 63110
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Tennessee
- Unknown facility, Memphis, Tennessee, 38120
- Unknown facility, Memphis, Tennessee, 38120
- Unknown facility, Chattanooga, Tennessee, 37404
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Illinois
- Unknown facility, Naperville, Illinois, 60540
- Unknown facility, Naperville, Illinois, 60540
- Unknown facility, Harvey, Illinois, 60426
- Unknown facility, Harvey, Illinois, 60426
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Wisconsin
- Unknown facility, Wauwatosa, Wisconsin, 53226
- Unknown facility, Wauwatosa, Wisconsin, 53226
- Unknown facility, Milwaukee, Wisconsin, 53226
- Unknown facility, Green Bay, Wisconsin, 54311
- Unknown facility, Green Bay, Wisconsin, 54311
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Alabama
- Unknown facility, Mobile, Alabama, 36604
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Ohio
- Unknown facility, Cincinnati, Ohio, 45242
- Unknown facility, Cincinnati, Ohio, 45242
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