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

A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma

The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC).

The study was conducted in two phases. In phase 1, patients with advanced cancer received different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of phase 1 was to determine the safest dose of the combined study medications. This dose was administered to patients with previously untreated NSCLC in phase 2. The phase 2 portion of the study determined if the combination is effective in treating NSCLC.

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
• Eastern Cooperative Oncology Group (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