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

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Neoplasms
• Germinoma
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Ovarian Sarcoma
• Ovarian Stromal Cancer
• Recurrent Endometrial Carcinoma
• Recurrent Ovarian Epithelial Cancer
• Recurrent Ovarian Germ Cell Tumor
• Stage III Endometrial Carcinoma
• Stage III Ovarian Epithelial Cancer
• Stage III Ovarian Germ Cell Tumor
• Stage IV Endometrial Carcinoma
• Stage IV Ovarian Epithelial Cancer
• Stage IV Ovarian Germ Cell Tumor
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT00408655
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 1
• Start date: February 2007