A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma
The study will be conducted in two phases. In phase 1, patients with advanced cancer will
receive different doses of aflibercept in combination with approved doses of pemetrexed and
cisplatin. The objective of phase 1 is to determine the safest dose of the combined study
medications. This dose will then be administered to patients with previously untreated
non-small cell lung cancer in phase 2. The phase 2 portion of the study will determine if
the combination is effective in treating non-small cell lung cancer.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase 1: Dose limiting toxicities; Phase 2: Objective Response Rate (ORR) and Progression Free Survival (PFS)
6 months
Yes
Clinical Trial Management
Study Director
Regeneron Pharmaceuticals
United States: Food and Drug Administration
VGFT-ST-0708
NCT00794417
November 2008
June 2011
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
University of Arkansas for Medical Science | Little Rock, Arkansas 72205 |
Sidney Kimmel Comprehensive Cancer Center | Lutherville, Maryland |
Kentucky Cancer Clinic | Pikeville, Kentucky 41501 |
Presbyterian Hospital Center for Cancer Research | Charlotte, North Carolina 28204 |
Palm Beach Institute of Hematology and Oncology | Boynton Beach, Florida 33435 |
Arizona Cancer Institute, LLC | Tucson, Arizona 85715 |
Edward Hines Jr. VA Medical Center | Hines, Illinois 60141 |
UNM Cancer Clinic | Albuquerque, New Mexico 87131 |
Erie Regional Cancer Center | Erie, Pennsylvania 16505 |
Schiffler Cancer Center - Medical Oncology Division | Wheeling, West Virginia 26003 |