A Phase I, and Biologic Correlative Study of Erlotinib, in Combination With Cetuximab and Bevacizumab in Patients With Metastatic Renal Cell Carcinoma
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.
I. Compare, preliminarily, the toxicity and antitumor activity profiles of these regimens in
OUTLINE: This is an open-label, multicenter, dose-escalation study of erlotinib and
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
In both groups, courses repeat every 28 days in the absence of unacceptable toxicity or
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
Maximum tolerated dose (MTD) of erlotinib hydrochloride combined with cetuximab determined by dose-limiting toxicities (DLT) graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3 (Part I)
The occurrence and maximal grade of toxicity for the whole duration of treatment will be listed and tabulated by type.
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
United States: Food and Drug Administration
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