A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma
Trial ID or NCT#
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).
A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma
- - 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
- - 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
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