CCI-779 and EKB-569 in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00098501|
Recruitment Status : Completed
First Posted : December 8, 2004
Last Update Posted : June 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: pelitinib Drug: temsirolimus||Phase 1|
I. Determine the maximum tolerated dose of the combination of CCI-779 and EKB-569 in patients with advanced solid tumors.
II. Determine the toxicity of this regimen in these patients. III. Determine the response rate in patients treated with this regimen.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 3 treatment groups.
Group I: Patients receive oral EKB-569 on days 1-28 and oral CCI-779 on days 1-7 and 15-21.
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.
Group II: Patients receive oral EKB-569 at the MTD on days 4-28 of course 1 and days 1-28 of all subsequent courses and CCI-779 at the MTD on days 1-3 and 15-17.
Group III: Patients receive EKB-569 at the MTD as in group I and oral CCI-779 at the MTD on days 7-9 and 19-21 of course 1 and days 1-3 and 15-17 of all subsequent courses.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Trial of CCI-779 in Combination With EKB-569, an EGFR Inhibitor, in Patients With Solid Tumors|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||October 2007|
Experimental: Arm I
Patients receive oral EKB-569 on days 1-28 and oral CCI-779 on days 1-7 and 15-21.
Other Name: EKB-569Drug: temsirolimus
- Maximum tolerated dose (MTD) defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients [ Time Frame: Up to 28 days ]
- Number and severity of all adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 [ Time Frame: Up to 30 days after last dose of study treatment ]Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
- Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Time from the start of the treatment until disease progression/recurrence, assessed up to 3 years ]
- Time until any treatment related toxicity [ Time Frame: Up to 3 years ]
- Time until treatment related grade 3+ toxicity [ Time Frame: Up to 3 years ]
- Time until hematologic nadirs (white blood cells [WBC], absolute neutrophil count [ANC], platelets) [ Time Frame: Up to 3 years ]
- Time to progression [ Time Frame: Up to 3 years ]
- Time to treatment failure [ Time Frame: Time from registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098501
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Charles Erlichman||Mayo Clinic|