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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00794417
First received: November 19, 2008
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

The purpose of the study is to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective.


Condition Intervention Phase
Advanced Carcinoma
Non-small Cell Lung Cancer
Biological: Aflibercept
Biological: Pemetrexed
Biological: Cisplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Phase 1: Dose limiting toxicities; Phase 2: Objective Response Rate (ORR) and Progression Free Survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety, pharmacokinetic and immunogenic profile of aflibercept when given in combination with pemetrexed and cisplatin [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: November 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Aflibercept
Administered in combination with the other two interventions via intravenous infusion.
Biological: Pemetrexed
Administered in combination with the other two interventions via intravenous infusion.
Other Name: Alimta
Biological: Cisplatin
Administered in combination with the other two interventions via intravenous infusion.
Other Name: Platinol

Detailed Description:

The study will be conducted in two phases. In phase 1, patients with advanced cancer will receive different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of phase 1 is to determine the safest dose of the combined study medications. This dose will then be administered to patients with previously untreated non-small cell lung cancer in phase 2. The phase 2 portion of the study will determine if the combination is effective in treating non-small cell lung cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794417

Locations
United States, Arizona
Arizona Cancer Institute, LLC
Tucson, Arizona, United States, 85715
United States, Arkansas
University of Arkansas for Medical Science
Little Rock, Arkansas, United States, 72205
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, United States, 33435
United States, Illinois
Edward Hines Jr. VA Medical Center
Hines, Illinois, United States, 60141
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231-1000
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
UNM Cancer Clinic
Albuquerque, New Mexico, United States, 87131
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, North Carolina
Presbyterian Hospital Center for Cancer Research
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
Erie Regional Cancer Center
Erie, Pennsylvania, United States, 16505
United States, West Virginia
Schiffler Cancer Center - Medical Oncology Division
Wheeling, West Virginia, United States, 26003
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00794417     History of Changes
Other Study ID Numbers: VGFT-ST-0708, TCD10767
Study First Received: November 19, 2008
Last Updated: August 30, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Regeneron Pharmaceuticals:
advanced cancer
lung cancer
NSCLC
Non-small Cell Lung Cancer
aflibercept
chemotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 26, 2014