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| Sponsor: | Regeneron Pharmaceuticals |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by (Responsible Party): | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00794417 |
Purpose
The purpose of the study is to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Carcinoma Non-small Cell Lung Cancer |
Biological: Aflibercept Biological: Pemetrexed Biological: Cisplatin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma |
| Enrollment: | 62 |
| Study Start Date: | November 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Aflibercept
Administered in combination with the other two interventions via intravenous infusion.
Biological: Pemetrexed
Administered in combination with the other two interventions via intravenous infusion.
Other Name: Alimta
Biological: Cisplatin
Administered in combination with the other two interventions via intravenous infusion.
Other Name: Platinol
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following up to 6 months (24 weeks) prior to the initial administration of aflibercept:
Contacts and Locations| United States, Arizona | |
| Arizona Cancer Institute, LLC | |
| Tucson, Arizona, United States, 85715 | |
| United States, Arkansas | |
| University of Arkansas for Medical Science | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| United States, Florida | |
| Palm Beach Institute of Hematology and Oncology | |
| Boynton Beach, Florida, United States, 33435 | |
| United States, Illinois | |
| Edward Hines Jr. VA Medical Center | |
| Hines, Illinois, United States, 60141 | |
| United States, Kentucky | |
| Kentucky Cancer Clinic | |
| Hazard, Kentucky, United States, 41701 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center | |
| Baltimore, Maryland, United States, 21231-1000 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Mexico | |
| UNM Cancer Clinic | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| United States, North Carolina | |
| Presbyterian Hospital Center for Cancer Research | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Pennsylvania | |
| Erie Regional Cancer Center | |
| Erie, Pennsylvania, United States, 16505 | |
| United States, West Virginia | |
| Schiffler Cancer Center - Medical Oncology Division | |
| Wheeling, West Virginia, United States, 26003 | |
| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
More Information
| Responsible Party: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00794417 History of Changes |
| Other Study ID Numbers: | VGFT-ST-0708, TCD10767 |
| Study First Received: | November 19, 2008 |
| Last Updated: | January 6, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
|
advanced cancer lung cancer NSCLC |
Non-small Cell Lung Cancer aflibercept chemotherapy |
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Pemetrexed Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |