Metastatic Colorectal Cancer
Conditions
Keywords
CRC, Colon cancer, Avastin, APM4566g
Brief summary
This will be a multicenter, open-label study enrolling a total of up to 23 patients.
Interventions
DRUGbevacizumab
Intravenous repeating dose
DRUGFOLFOX
Intravenous repeating dose
DRUGPRO95780
Intravenous repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed CRC with evidence of locally advanced recurrent or metastatic disease and measurable tumor lesions * Life expectancy \> 3 months * For patients of reproductive potential (males and females), use of reliable means for contraception throughout the trial and for 6 months following their final exposure to study treatment * Willingness and capability to be accessible for study follow-up
Exclusion criteria
* Prior 5-FU, capecitabine, and/or oxaliplatin treatment with the exception of: prior oxaliplatin treatment≤ 6 weeks in the advanced or metastatic setting; prior treatment with 5-FU, capecitabine, and/or oxaliplatin in the adjuvant setting if relapse occurred \> 6 months from concluding adjuvant therapy * Peripheral neuropathy Grade ≥ 2 * Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy * Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1, or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1 * Chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to Cycle 1, Day 1 * Evidence of clinically detectable ascites * Other invasive malignancies within 5 years prior to Cycle 1, Day 1 * History or evidence upon physical examination of active central nervous system (CNS) disease * Current or recent participation in another experimental drug study * Clinically significant cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia within 1 year prior to Cycle 1, Day 1, or Grade II or greater peripheral vascular disease * Active infection requiring parenteral antibiotics * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Cycle 1, Day 1, fine needle aspirations within 7 days prior to Cycle 1, Day 1, or anticipation of need for major surgical procedure during the course of the study * Known or suspected to be positive for the human immunodeficiency virus (HIV) * Known to be positive for hepatitis C or hepatitis B surface antigen * Inadequately controlled hypertension * Prior history of hypertensive crisis or hypertensive encephalopathy * History of arterial thromboembolic event 6 months prior to Cycle 1, Day 1 * History of abdominal fistula or gastrointestinal perforation within 6 months prior to Cycle 1, Day 1 * Bleeding diathesis or coagulopathy * Pregnancy (positive pregnancy test) or breast feeding * Serious, non-healing wound, ulcer, or bone fracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and nature of dose-limiting toxicities | Length and study |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, nature, and severity of adverse events | Length of study |
| Change in vital signs | Length of study |
| Incidence and severity of infusion reactions | Length of study |
| Change in clinical laboratory results | Length of study |
| Incidence of anti-PRO95780 antibodies | Length of study |
Outcome results
None listed