Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients, \>18 years of age, able to understand and give written informed consent.
Histologically or cytologically confirmed colorectal adenocarcinoma.
Stage IV (metastatic) disease.
Failed at least one prior standard treatment regimen for colorectal cancer
Adequate performance status (ECOG 0 or 1)
Expected survival \> 6 months.
CEA plasma levels \> 5 ng/mL
Measurable disease by CT or MRI
At least 4 weeks beyond major surgery and recovered from all acute toxicities
At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis
Adequate hematology without ongoing transfusional support (hemoglobin \> 9 g/dL, ANC \> 1,500 per mm3, platelets \> 100,000 per mm3)
Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin ≤ IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
Otherwise, all toxicity at study entry \<Grade 1 by NCI CTC v4.0.
You may not be if
Women who are pregnant or lactating.
Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
Patient's with Gilbert's disease or known CNS Metastatic disease. However, patients with CNS metastases who are asymptomatic and have completed a course of therapy are eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new enlarging CNS metastasis (2) off steroids or on a stable dose of steroids
Patients with CEA plasma level \> 1000 ng/mL are excluded during dose escalation, but may be included after the MTD is determined
Patients with active grade 3 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 3-year disease free interval.
Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy,
Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids, and other than diabetes, vitiligo, or stable thyroid disease).
Infection requiring intravenous antibiotic use within 1 week.
Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
