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A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma
This study is currently recruiting participants.
Verified by Regeneron Pharmaceuticals, November 2008
Sponsors and Collaborators: Regeneron Pharmaceuticals
Sanofi-Aventis
Information provided by: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00794417
  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
Drug: Combination of aflibercept, pemetrexed and cisplatin
Phase I
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Cisplatin Pemetrexed disodium Pemetrexed Aflibercept
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma

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 ]

Estimated Enrollment: 100
Study Start Date: September 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Combination of aflibercept, pemetrexed and cisplatin
Aflibercept in combination with pemetrexed and cisplatin administered via intravenous infusion.

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

Locations
United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Melanie San Pedro-Salcedo     650-724-1388     msanpedro@stanford.edu    
Principal Investigator: Heather Wakelee, MD            
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada
Contact: Lillian Siu, MD     416-946-2911     Lillian.siu@uhn.on.ca    
Principal Investigator: Lillian Siu, MD            
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi-Aventis
Investigators
Study Director: MD Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals ( Study Manager )
Study ID Numbers: VGFT-ST-0708, TCD10767
Study First Received: November 19, 2008
Last Updated: November 19, 2008
ClinicalTrials.gov Identifier: NCT00794417  
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

Study placed in the following topic categories:
Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009