huC242-DM4 Treating Patients With Metastatic Gastric or Gastroesophageal Junction Carcinomas

Inclusion Criteria

• •Patients must understand and voluntarily sign an informed consent.
• •Patients must have histological documentation of metastatic or locally advanced (American Joint Committee on Cancer Staging System: Stages IIIA, IIIB, and IV) gastric or gastroesophageal junction adenocarcinoma.
• •Patients must have ECOG performance status \< 1.
• •Patients must be at least 18 years of age.
• •Patients who have been treated with only one prior chemotherapy regimen and who have documented disease progression.
• •Patients must have confirmation of CanAg expression performed prior to enrollment by immunohistochemical assessment for CanAg on archived biopsy samples.
• •Patients must have measurable disease with at least one lesion that can be accurately measured by Response Evaluation Criteria in Solid Tumors (RECIST). The lesion size must be at least 20 mm by conventional radiological techniques or at least 10 mm by spiral CT scan. Disease in an irradiated field as the only site of measurable disease is acceptable if there has been a clear progression of the lesion.
• •Patients with reproductive potential must agree to use an effective contraceptive method during the study and for 30 days after receiving the last dose of study drug.
• •Women of childbearing potential (WCBP) must have a negative urine or serum pregnancy test within one week prior to enrollment in the study.
• •Patients must have any chemotherapy, immunotherapy, hormonal therapy, radiotherapy for cancer or surgery (except for minor surgical procedures) completed at least 3 weeks before starting study medication.
• •Patients must have resolution of all clinically significant toxic effects (excluding alopecia) of any prior treatments including surgery, radiotherapy, hormone therapy, immunotherapy, targeted non-cytotoxic therapy, or chemotherapy to grade ≤ 1 by NCI CTCAE v. 3.0 unless otherwise specified in the inclusion laboratory values.
• •Patients must have adequate organ function including:
• •1. Hematopoietic:
• •i. Absolute neutrophil count \> 1,500/mm3. ii. Platelet count \> 100,000/mm3. iii. Hemoglobin \> 9 g/dL (transfusion allowed).
• •2. Renal:
• •i. Serum creatinine ≤ 1.5 x the upper limit of normal (ULN) ii. Calculated creatinine clearance \> 60 mL/min/1.73m2.
• •3. Hepatic:
• •i. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) ≤ 2.5 x ULN ii. Total bilirubin ≤ 1.5 x ULN