NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT00794417

TerminatedPhase 1, Phase 2

Sponsor: Regeneron Pharmaceuticals

Conditions: Advanced Carcinoma, Non-small Cell Lung Cancer

Interventions: Aflibercept, Pemetrexed, Cisplatin

Countries: United States, Canada

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (15)

Tucson, Arizona, United States
Little Rock, Arkansas, United States
Stanford, California, United States
Boynton Beach, Florida, United States
Hines, Illinois, United States
Hazard, Kentucky, United States
Baltimore, Maryland, United States
Lebanon, New Hampshire, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Erie, Pennsylvania, United States
Wheeling, West Virginia, United States
Toronto, Ontario, Canada