A Phase I, Pharmacokinetic, and Biologic Correlative Study of R115777 (NSC 702818) and Herceptin in Patients With Advanced Cancer
I. Determine the maximum tolerated dose of R115777 when administered with trastuzumab
(Herceptin) in patients with advanced or metastatic adenocarcinoma.
II. Assess the toxicities and pharmacokinetics of this treatment regimen in this patient
III. Determine the antitumor activity of this treatment regimen in these patients.
IV. Determine the relative biologic endpoints of this regimen and correlate them with
toxicity and pharmacokinetic parameters in these patients.
OUTLINE: This is a dose escalation, multicenter study of R115777.
Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus
oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of
disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating
doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.
Patients are followed every 30 days until toxicity resolves.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Anthony W. Tolcher, MD
San Antonio Cancer Institute
United States: Food and Drug Administration
|Brooke Army Medical Center||Fort Sam Houston, Texas 78234-6200|
|Institute for Drug Development||San Antonio, Texas 78245-3217|