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Sponsors and Collaborators: |
Cancer Therapy and Research Center, Texas National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00255658 |
RATIONALE: Sorafenib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with temsirolimus may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of temsirolimus when given together with sorafenib in treating patients with unresectable or metastatic solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: sorafenib tosylate Drug: temsirolimus |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I, Pharmacokinetic and Pharmacodynamic Study of BAY 43-9006 (Sorafenib) in Combination With CCI-779 (Temsirolimus) in Advanced Solid Malignancies |
Estimated Enrollment: | 40 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study of temsirolimus.
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. They also receive oral sorafenib* twice daily starting on day 8 of course 1. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
NOTE: *On the days of the temsirolimus infusion, temsirolimus should be taken concurrently with the morning dose of sorafenib.
Cohorts of 3-6 patients receive escalating doses of temsirolimus 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. Up to 12 patients are treated at the MTD.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
CNS metastases allowed provided all of the following criteria are met:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Radiotherapy
Surgery
Other
Concurrent full-dose anticoagulation therapy (e.g., warfarin) allowed provided all of the following criteria are met:
No concurrent enzyme-inducing antiepileptic drugs, including any of the following:
United States, Texas | |
Cancer Therapy and Research Center | |
San Antonio, Texas, United States, 78229 |
Study Chair: | Muralidhar Beeram, MD | Cancer Therapy and Research Center, Texas |
Study ID Numbers: | CDR0000446567, CTRC-IDD-0512, NCI-7146 |
Study First Received: | November 18, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00255658 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Protein Kinase Inhibitors Sorafenib |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
Protein Kinase Inhibitors Sorafenib Pharmacologic Actions |