Status:
TERMINATED
A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Advanced Carcinoma
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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).
Detailed Description
The study was conducted in two phases. In phase 1, patients with advanced cancer received different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00794417
Start Date
November 30 2008
End Date
June 30 2011
Last Update
December 10 2020
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Cancer Institute, LLC
Tucson, Arizona, United States, 85715
2
University of Arkansas for Medical Science
Little Rock, Arkansas, United States, 72205
3
Stanford University Medical Center
Stanford, California, United States, 94305
4
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, United States, 33435