Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic/Colorectal Cancer

Inclusion Criteria

• •Histologically confirmed adenocarcinoma of the pancreas, colon or rectum.
• •Radiographic evidence of metastatic cancer of the colon or rectum.
• •Pancreatic cancer that is unresectable or already metastatic, or colorectal cancer that has failed available approved treatment modalities.
• •For pancreatic cancer patients, prior chemotherapy is not required; for colon and rectal cancer patients must have failed available chemotherapy/targeted regimens. There were no limits to the number of prior chemotherapeutic regimens.
• •The patient had evidence of progressive disease defined as at least one of the following:
• •1. Progressive measurable disease using conventional solid tumor criteria.
• •2. Increasing tumor markers and/or activity on positron emission tomography / standard uptake value (PET/SUV) measurement.
• •All clinically significant toxic effects (excluding alopecia) of prior surgery, radiotherapy, or hormonal therapy were resolved to ≤ Grade 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v.3.0) with the exception of neuropathy, which was resolved to ≤ Grade 2.
• •Performance status (ECOG PS) 0-2.
• •Adequate hematologic function, minimum requirements:
• •1. absolute neutrophil count (ANC) ≥ 1500/mL
• •2. hemoglobin ≥ 9 g/dL
• •3. platelets ≥ 100,000/mL
• •Adequate hepatic function, defined as follows:
• •1. bilirubin ≤ 1.5 times the upper limit of normal (ULN)
• •2. aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times the ULN, or ≤ 5 times the ULN if liver metastases are present
• •Adequate renal function, defined as serum creatinine ≤ 2.0 mg/dL.
• •Adequate coagulation function, defined as follows:
• •1. an international normalized ratio (INR) ≤ 1.5
• •2. a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN, unless on anti-coagulant therapy
• •3. patients receiving full-dose anticoagulation therapy were eligible provided they met all other criteria, were on a stable dose or anticoagulant therapy or low molecular weight heparin (and if on warfarin had a therapeutic INR between 2-3)
• •Life expectancy of at least 6 weeks.
• •For females of childbearing potential, a negative pregnancy test.
• •Agrees to contraceptive use (barrier method) while on study, if sexually active.
• •Provided signed informed consent.