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©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT00794417
A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma
Professor of Medicine (Oncology)
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Colleen Haas Chair in the School of Medicine
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
drug: Aflibercept
drug: Pemetrexed
drug: Cisplatin
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061