Open-Label Phase IIb Efficacy Trial of Cancer Macrobeads Compared to Best Supportive Care in Colorectal Cancer Patients

Inclusion Criteria

• •Patients in both treatment groups must meet all of the following criteria to be considered eligible to participate in the study:
• •Adult men or women, aged 18 years or older, with histologically-confirmed, metastatic adenocarcinoma of the colon or rectum that has been proven to be resistant to available treatment options, including at least 2 such options from available chemotherapy, targeted, and/or other regimens.
• •Radiographic evidence of disease progression.
• •Life expectancy of at least 6 weeks, in the investigator's opinion, at the time disease progression is documented.
• •Considered surgical candidates on the basis of co-morbidity risks, number and sites of metastases, and ability to undergo general anesthesia.
• •Able to understand the risks of experimental therapy and provide written consent by signing the appropriate form.
• •Patients in Group A must also meet all of the following additional criteria:
• •ECOG performance status score of 0, 1, or 2.
• •Adequate hematologic function, defined as follows:
• •1. absolute neutrophil count (ANC) ≥1500 /mL
• •2. hemoglobin ≥9 g/dL
• •3. platelets ≥75,000 /mL
• •Adequate hepatic function, defined as follows:
• •1. bilirubin ≤1.5 times the upper limit of normal (x ULN)
• •2. aspartate transaminase (AST) ≤3 x ULN, or ≤5 x ULN if liver metastases are present
• •3. alanine transaminase (ALT) ≤3, x ULN, or ≤5 x ULN if liver metastases are present
• •Adequate renal function, defined as creatinine ≤2.0 mg/dL.
• •Adequate coagulation function, defined as follows:
• •1. International Normalized Ratio (INR) ≤1.5 or between 2 and 3 if the patient is receiving anticoagulation
• •2. Partial Thromboplastin Time (PTT) ≤5 seconds above the ULN Note: Patients receiving full-dose anticoagulation therapy must have received a stable dose of oral anticoagulant therapy or low-molecular-weight heparin.
• •Clinically significant toxic effects of chemotherapy (excluding alopecia), radiotherapy, hormonal therapy, or prior surgery must have resolved to Grade 1 or better, with the exception of peripheral neuropathy, which must have resolved to Grade 2 or better.
• •Female participants of childbearing potential must have had a negative serum pregnancy test at screening; and must also agree to contraceptive use while on study if sexually active. Male subjects and their partners must have agreed to use condoms.