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A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Carcinoma, Non-small Cell Lung Cancer

Thank you

Trial Information

A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 1: Dose limiting toxicities; Phase 2: Objective Response Rate (ORR) and Progression Free Survival (PFS)

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Clinical Trial Management

Investigator Role:

Study Director

Investigator Affiliation:

Regeneron Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

VGFT-ST-0708

NCT ID:

NCT00794417

Start Date:

November 2008

Completion Date:

June 2011

Related Keywords:

  • Advanced Carcinoma
  • Non-Small Cell Lung Cancer
  • advanced cancer
  • lung cancer
  • NSCLC
  • Non-small Cell Lung Cancer
  • aflibercept
  • chemotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
Stanford University Medical Center Stanford, California  94305-5408
Montefiore Medical Center Bronx, New York  10467-2490
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
University of Arkansas for Medical Science Little Rock, Arkansas  72205
Sidney Kimmel Comprehensive Cancer Center Lutherville, Maryland  
Kentucky Cancer Clinic Pikeville, Kentucky  41501
Presbyterian Hospital Center for Cancer Research Charlotte, North Carolina  28204
Palm Beach Institute of Hematology and Oncology Boynton Beach, Florida  33435
Arizona Cancer Institute, LLC Tucson, Arizona  85715
Edward Hines Jr. VA Medical Center Hines, Illinois  60141
UNM Cancer Clinic Albuquerque, New Mexico  87131
Erie Regional Cancer Center Erie, Pennsylvania  16505
Schiffler Cancer Center - Medical Oncology Division Wheeling, West Virginia  26003