Gastric Cancer Clinical Trial
Official title:
A Phase I Dose Escalation Study of Edotecarin (PHA-782615) and Cisplatin in Adult Patients With Advanced/Metastatic Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as edotecarin and cisplatin, use different ways
to stop tumor cells from dividing so they stop growing or die. Combining edotecarin with
cisplatin may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining edotecarin with cisplatin in
treating patients who have advanced or metastatic solid tumors.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
day 1.
In both schedules, courses repeat every 3 weeks in the absence of disease progression or
unacceptable toxicity.
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
study.
;
Masking: Open Label, Primary Purpose: Treatment
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