A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma

Inclusion Criteria:

• Confirmation of cancer by biopsy (tissue sample)
• Phase 1: patients with advanced or metastatic disease that have failed conventional therapy
• Phase 2: patients with previously untreated NSCLC, excluding squamous cell histology and cavitating lesions
• Age ≥18 years
• ECOG performance status 0-1
• Adequate renal, liver and bone marrow function.
• Negative pregnancy test (serum or urine) in females of childbearing potential within 7 days of the initial dose of aflibercept
• Ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
• Institutional Review Board (IRB) approved, signed and dated informed consent form

Exclusion Criteria:

• Prior treatment with study medications
• Untreated, symptomatic, or progressive Central Nervous System cancer and/or spinal cord compression. Patients with treated brain metastases must have been without symptoms for at least 3 months
• Surgery up to 4 weeks prior to the initial administration of aflibercept and/or incomplete wound healing
• Anti-VEGF therapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
• Chemotherapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
• Other investigational treatment up to 4 weeks prior to the initial administration of aflibercept

• Any of the following up to 6 months (24 weeks) prior to the initial administration of aflibercept:

  • Severe cardiovascular disease or event
  • Cerebrovascular accident, transient ischemic attack, or moderate to severe peripheral neuropathy
  • Erosive esophagitis or gastritis, infectious or inflammatory bowel disease, and diverticulitis
  • Deep vein thrombosis, pulmonary embolism, or other clotting event
  • Episode(s)of moderate to severe, continuous bleeding
• Breast-feeding or pregnancy