Gene Therapy Clinical Trials
A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma
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).
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Aflibercept
- drug: Pemetrexed
- drug: Cisplatin
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting