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CCI-779 and EKB-569 in Treating Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

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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.

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of the combination of CCI-779 and EKB-569 in patients with advanced solid tumors.
  • Determine the toxicity of this regimen in these patients.
  • 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 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
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  42
Start Date  November 2004
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically confirmed unresectable solid tumor for which there is no known standard therapy that is potentially curative or capable of extending life expectancy
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL

Hepatic

  • Bilirubin normal
  • AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver involvement)

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No New York Heart Association class III or IV heart disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • Fasting cholesterol < 350 mg/dL
  • Fasting triglycerides < 400 mg/dL
  • No uncontrolled infection
  • No seizure disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior biologic therapy
  • No concurrent immunotherapy
  • No concurrent prophylactic colony-stimulating factor therapy

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent oral contraceptives

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to > 30% of bone marrow
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • More than 7 days since prior CYP3A4 inducers
  • No prior mTOR-targeting agents
  • No prior epidermal growth factor receptor-targeting agents
  • No concurrent antiretroviral therapy that induces or inhibits CYP3A4 for HIV-positive patients
  • No other concurrent investigational agents
  • No concurrent warfarin
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 
Study Chair:     Charles Erlichman, MD     Mayo Clinic    
Information Provided By National Cancer Institute (NCI)
Verification Date September 2007
First Received Date  December 7, 2004
Last Updated Date May 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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