A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma
Trial ID or NCT#
Status
Purpose
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).
Official Title
A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma
Eligibility 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
- * 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
Investigator(s)
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Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov