Lung Cancer Clinical Trial
Official title:
Phase II Open-Label Study of Volociximab (M200) in Combination With Erlotinib (Tarceva™) in Previously Treated Patients With Locally Advanced (Stage IIIb) or Metastatic (Stage IV) Non-Small Cell Lung Cancer
RATIONALE: Monoclonal antibodies, such as volociximab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Volociximab may also stop the
growth of non-small cell lung cancer by blocking blood flow to the tumor. Erlotinib may stop
the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
volociximab together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving volociximab together with erlotinib
works in treating patients with stage III or stage IV non-small cell lung cancer.
OBJECTIVES:
Primary
- Evaluate the response rate in patients with locally advanced (stage IIIB) or metastatic
(stage IV) non-small cell lung cancer treated with volociximab and erlotinib
hydrochloride.
Secondary
- Evaluate the time to disease progression and duration of response in patients treated
with this regimen.
- Evaluate the safety of this drug regimen in these patients.
- Evaluate the pharmacokinetics this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive volociximab IV over 30 minutes once every 2 weeks and oral erlotinib
hydrochloride daily for 52 weeks in the absence of unacceptable toxicity or disease
progression.
After completion of study treatment, patients are followed at 3 and 6 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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