Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase I, and Biologic Correlative Study of Erlotinib, in Combination With Cetuximab and Bevacizumab in Patients With Metastatic Renal Cell Carcinoma
This randomized phase I/II trial studies the side effects, best way to give, and best dose of erlotinib and bevacizumab when given with cetuximab and how well giving erlotinib and cetuximab together with or without bevacizumab works in treating patients with metastatic or unresectable kidney, colorectal, head and neck, pancreatic, or non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab and bevacizumab, 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. Cetuximab and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with cetuximab and/or bevacizumab may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of erlotinib when combined with cetuximab in
patients with metastatic or unresectable renal cell, colorectal, head and neck, pancreatic,
or non-small cell lung cancer (part 1).
II. Determine the MTD of bevacizumab when combined with cetuximab and erlotinib in these
patients (part 2).
III. Determine the toxic effects, both quantitatively and qualitatively, of these regimens
in these patients.
IV. Determine the antitumor activity of these regimens, in terms of tumor response,
short-term survival, and progression-free survival, in these patients.
SECONDARY OBJECTIVES:
I. Compare, preliminarily, the toxicity and antitumor activity profiles of these regimens in
these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study of erlotinib and
bevacizumab.
Part 1: Patients receive oral erlotinib once daily on days 1-28. Patients also receive
cetuximab IV over 3 hours on day 1 and over 1 hour on days 8, 15, and 22.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Part 2: Patients receive erlotinib as in part 1 at the MTD and cetuximab as in part 1.
Patients also receive bevacizumab IV over 1½ hours on day 1 and over 1 hour on day 15.
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the MTD is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity.
In both groups, courses repeat every 28 days in the absence of unacceptable toxicity or
disease progression.
After completion of study treatment, patients are followed at 1 month.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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