Phase I Study of CCI-779 (NSC 683864, IND #61010) in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumours
I. Determine the maximum tolerated dose (MTD) and recommended phase II dose of temsirolimus,
carboplatin, and paclitaxel in patients with advanced solid tumors.
I. Determine the frequency and severity of toxic effects of this regimen in these patients.
II. Document any evidence of objective antitumor activity of this regimen in patients with
III. Determine the pharmacokinetic profile of carboplatin and paclitaxel alone, temsirolimus
alone, and carboplatin, paclitaxel, and temsirolimus in combination in these patients.
OUTLINE: This is a multicenter, open-label, dose-escalation study. Patients receive
treatment in either part A or part B.
PART A: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60
minutes on day 1 and temsirolimus IV over 30 minutes on days 8 and 15. Treatment repeats
every 21 days for up to 8 courses in the absence of disease progression or unacceptable
PART B: Patients receive paclitaxel and carboplatin as in part A. They also receive
temsirolimus IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 8
courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients in parts A and B receive escalating doses of temsirolimus,
carboplatin, and paclitaxel 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. The recommended phase II dose (RPTD) is the dose that is one dose
level below the MTD. Once the RPTD is determined in part A, patients are enrolled in part B.
An expanded cohort of up to 10 patients with endometrial or ovarian cancer are treated at
the RPTD determined in part B (final RPTD).
After completion of study treatment, patients are followed at 4 weeks and then every 3
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II dose of temsirolimus, carboplatin, and paclitaxel
Up to 3 years
NCIC Clinical Trials Group
United States: Food and Drug Administration