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

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Carcinoma, Non-small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT00794417

Run by

Regeneron Pharmaceuticals

People needed

60

Starts

2008-11-30

Expected to finish

2011-06-30

Last updated by the study team

2020-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Cancer Institute, LLC — Tucson, Arizona, United States
• University of Arkansas for Medical Science — Little Rock, Arkansas, United States
• Stanford University Medical Center — Stanford, California, United States
• Palm Beach Institute of Hematology and Oncology — Boynton Beach, Florida, United States
• Edward Hines Jr. VA Medical Center — Hines, Illinois, United States
• Kentucky Cancer Clinic — Hazard, Kentucky, United States
• Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• UNM Cancer Clinic — Albuquerque, New Mexico, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Presbyterian Hospital Center for Cancer Research — Charlotte, North Carolina, United States
• Erie Regional Cancer Center — Erie, Pennsylvania, United States
• Schiffler Cancer Center - Medical Oncology Division — Wheeling, West Virginia, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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