Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent
Age \>=18 years
Histologically confirmed colorectal carcinoma with evidence of metastases (i.e., by radiographic imaging or biopsy)
Ability to tolerate CT contrast dye
Bi-dimensionally measurable disease (minimum of two lesions)
ECOG performance status of 0 or 1
Use of an effective means of contraception in women of childbearing potential
Life expectancy of \>3 months
Willingness and capability to be accessible for follow-up until death or study termination by Genentech
You may not be if
Prior chemotherapy other than adjuvant fluoropyrimidines in combination with leucovorin and/or levamisole
Administration of adjuvant fluoropyrimidines in combination with leucovorin and/or levamisole completed \<=12 months prior to Day 0
Administration of fluoropyrimidines as a radiosensitizer during pelvic radiotherapy for rectal cancer completed \<=12 months prior to Day 0
Prior radiotherapy to a measurable, metastatic lesion(s) to be used to measure response
Radiation therapy within 14 days prior to Day 0
Prior biotherapy for colorectal cancer
Evidence of clinically detectable ascites on Day 0
Other invasive malignancies within 5 years prior to Day 0 (other than basal cell carcinoma of the skin)
History or evidence upon physical examination of CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)
Active infection requiring parenteral antibiotics on Day 0
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations within 7 days prior to Day 0
Current or recent (within the 10 days prior to Day 0) use of full-dose oral or parenteral anticoagulants (except as required to maintain patency of preexisting, permanent indwelling IV catheters) or thrombolytic agent (for subjects receiving warfarin, international normalized ratio \[INR\] of \<1.5; appropriate use of heparin should be discussed with the Medical Monitor)
Chronic, daily treatment with aspirin (\>325 mg/day) or nonsteroidal anti-inflammatory medications (of the kind known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
Pregnancy (positive pregnancy test) or lactation
Proteinuria at baseline or clinically significant impairment of renal function
Serious, nonhealing wound, ulcer, or bone fracture
Evidence of bleeding diathesis or coagulopathy
Current or recent (within the 28 days prior to Day 0) participation in another experimental drug study
Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or Grade II or greater peripheral vascular disease within 1 year prior to Day 0
Screening clinical laboratory values: \*ANC of \<1500/uL; \*Platelet count of \<75,000/uL; \*INR of \>=1.5; \*Total bilirubin of \>1.6 mg/dL; \*AST or ALT \>=5 times upper limit of normal for subjects with documented liver metastases (\>2.5 times the upper limit of normal for subjects without evidence of liver metastases); \*Serum creatinine of \>2.0 mg/dL; \*Hemoglobin of \<9 gm/dL (may be transfused to maintain or exceed this level)
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
Clareo Health | A Study to Evaluate Avastin in Combination With Standard Chemotherapy to Treat Colorectal Cancer
