A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma
NCT ID: NCT00794417
Last Updated: 2020-12-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2008-11-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin
Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m\^2 and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
Aflibercept
Administered in combination with the other two interventions via intravenous infusion.
Pemetrexed
Administered in combination with the other two interventions via intravenous infusion.
Cisplatin
Administered in combination with the other two interventions via intravenous infusion.
Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin
Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m\^2) and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
Aflibercept
Administered in combination with the other two interventions via intravenous infusion.
Pemetrexed
Administered in combination with the other two interventions via intravenous infusion.
Cisplatin
Administered in combination with the other two interventions via intravenous infusion.
Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin
Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m\^2 and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
Aflibercept
Administered in combination with the other two interventions via intravenous infusion.
Pemetrexed
Administered in combination with the other two interventions via intravenous infusion.
Cisplatin
Administered in combination with the other two interventions via intravenous infusion.
Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin
Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m\^2 and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles.
Aflibercept
Administered in combination with the other two interventions via intravenous infusion.
Pemetrexed
Administered in combination with the other two interventions via intravenous infusion.
Cisplatin
Administered in combination with the other two interventions via intravenous infusion.
Interventions
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Aflibercept
Administered in combination with the other two interventions via intravenous infusion.
Pemetrexed
Administered in combination with the other two interventions via intravenous infusion.
Cisplatin
Administered in combination with the other two interventions via intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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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
Countries
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References
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Diaz-Padilla I, Siu LL, San Pedro-Salcedo M, Razak AR, Colevas AD, Shepherd FA, Leighl NB, Neal JW, Thibault A, Liu L, Lisano J, Gao B, Lawson EB, Wakelee HA. A phase I dose-escalation study of aflibercept administered in combination with pemetrexed and cisplatin in patients with advanced solid tumours. Br J Cancer. 2012 Aug 7;107(4):604-11. doi: 10.1038/bjc.2012.319. Epub 2012 Jul 17.
Chen H, Modiano MR, Neal JW, Brahmer JR, Rigas JR, Jotte RM, Leighl NB, Riess JW, Kuo CJ, Liu L, Gao B, Dicioccio AT, Adjei AA, Wakelee HA. A phase II multicentre study of ziv-aflibercept in combination with cisplatin and pemetrexed in patients with previously untreated advanced/metastatic non-squamous non-small cell lung cancer. Br J Cancer. 2014 Feb 4;110(3):602-8. doi: 10.1038/bjc.2013.735. Epub 2013 Nov 28.
Other Identifiers
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TCD10767
Identifier Type: -
Identifier Source: secondary_id
VGFT-ST-0708
Identifier Type: -
Identifier Source: org_study_id