Clinical Trial: Temsirolimus, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I Study of CCI-779 (NSC 683864) in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumours

Brief Summary: 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.

Detailed Summary:

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
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Recommended phase II dose of temsirolimus, carboplatin, and paclitaxel [ Time Frame: Up to 3 years ]
  • Safety [ Time Frame: Up to 3 years ]
  • Tolerability [ Time Frame: Up to 3 years ]
  • Dose-limiting toxicities [ Time Frame: Up to 3 years ]


Original Primary Outcome:

  • Recommended phase II dose of temsirolimus, carboplatin, and paclitaxel
  • Safety
  • Tolerability
  • Dose-limiting toxicities


Current Secondary Outcome: Efficacy [ Time Frame: Up to 3 years ]

Original Secondary Outcome: Efficacy

Information By: National Cancer Institute (NCI)

Dates:
Date Received: December 6, 2006
Date Started: February 2007
Date Completion:
Last Updated: June 18, 2014
Last Verified: June 2014