Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Study of CCI-779 (NSC 683864) in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumours
This phase I trial is studying the side effects and best dose of temsirolimus, carboplatin, and paclitaxel in treating patients with advanced solid tumors. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus together with chemotherapy may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) and recommended phase II dose of temsirolimus,
carboplatin, and paclitaxel in patients with advanced solid tumors.
SECONDARY OBJECTIVES:
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
measurable disease.
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
toxicity.
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
months thereafter.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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