A Phase I Dose Escalation Study of Edotecarin (PHA-782615) and Cisplatin in Adult Patients With Advanced/Metastatic Solid Tumors
- Determine the maximum tolerated dose and recommended phase II dose of edotecarin when
administered with cisplatin (administered in 2 different schedules) in patients with
advanced or metastatic solid tumors.
- Determine the safety profile of this regimen in these patients.
- Determine the plasma pharmacokinetics of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study of edotecarin. Patients
are assigned to 1 of 2 schedules.
- Schedule A: Patients receive cisplatin IV over 30 minutes and edotecarin IV over 1 hour
on days 1 and 8.
- Schedule B: Patients receive cisplatin IV over 2 hours and edotecarin IV over 1 hour on
In both schedules, courses repeat every 3 weeks in the absence of disease progression or
Cohorts of 3-6 patients in each schedule receive escalating doses of edotecarin 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. Once the MTD is
determined, 10 additional patients with metastatic esophageal or gastric cancer receive
treatment as above at the MTD.
Patients are followed every 2 months for 1 year or until disease progression.
PROJECTED ACCRUAL: A maximum of 80 patients (40 per schedule) will be accrued for this
Masking: Open Label, Primary Purpose: Treatment
David H. Ilson, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|