©2022 Stanford Medicine
A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma
Not Recruiting
Trial ID: NCT00794417
Purpose
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).
Official Title
A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma
Stanford Investigator(s)
Heather Wakelee
Professor of Medicine (Oncology)
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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
Intervention(s):
drug: Aflibercept
drug: Pemetrexed
drug: Cisplatin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061