Phase I Study of 17- Allylamino-17 Demethoxygeldanamycin (17-AAG) in Combination With Paclitaxel in Advanced Solid Malignancies
I. Determine the maximum tolerated dose and recommended phase II dose of
17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when administered with paclitaxel in
patients with metastatic or unresectable solid malignancy.
II. Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these
III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine tumor
response in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of
17-N-allylamino-17-demethoxygeldanamycin (17-AAG). Patients receive 17-AAG IV over 1 hour
on days 1*, 4, 8, 11, 15 and 18 and paclitaxel IV over 1 hour on days 1, 8, and 15.
Treatment repeats every 28 days for 6 courses in the absence of disease progression or
NOTE: *17-AAG is not administered on day 1 of course 1. Cohorts of 3-6 patients receive
escalating doses of 17-AAG 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, 6-12 patients are treated at the
recommended phase II dose.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase 2 recommended doses of tanespimycin
Tabulated according to the NCI CTC.
University of Pennsylvania Medical Center
United States: Food and Drug Administration
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