A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma

Trial ID or NCT#

NCT00794417

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor
A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
George A. Fisher Jr.
George A. Fisher Jr.
Medical oncologist, Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine

Contact us to find out if this trial is right for you.

Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov