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| Descriptive Information Fields | |||||
| Brief Title † | CCI-779 and EKB-569 in Treating Patients With Advanced Solid Tumors | ||||
| Official Title † | A Phase I Trial Of CCI-779 In Combination With EKB-569, An EGFR Inhibitor, In Patients With Solid Tumors (Cohort B) | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. EKB-569 may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving CCI-779 together with EKB-569 may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of CCI-779 and EKB-569 in treating patients with advanced solid tumors. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 3 treatment groups.
Cohorts of 3-6 patients receive escalating doses of EKB-569 and CCI-779 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.
In all groups, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 30-42 patients (18-30 for group I, 6 for group II, and 6 for group III) will be accrued for this study within 1.35-1.75 years. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Unspecified Adult Solid Tumor, Protocol Specific | ||||
| Intervention † | Drug: EKB-569 Drug: temsirolimus |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 42 | ||||
| Start Date † | November 2004 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00098501 | ||||
| Organization ID | CDR0000398176 | ||||
| Secondary IDs †† | MAYO-MC027C, NCI-6200 | ||||
| Study Sponsor † | Mayo Clinic | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2007 | ||||
| First Received Date † | December 7, 2004 | ||||
| Last Updated Date | May 23, 2008 | ||||