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CCI-779 and EKB-569 in Treating Patients With Advanced Solid Tumors
This study has been completed.
Study NCT00098501   Information provided by National Cancer Institute (NCI)
First Received: December 7, 2004   Last Updated: February 13, 2009   History of Changes

December 7, 2004
February 13, 2009
November 2004
September 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00098501 on ClinicalTrials.gov Archive Site
 
 
 
CCI-779 and EKB-569 in Treating Patients With Advanced Solid Tumors
A Phase I Trial Of CCI-779 In Combination With EKB-569, An EGFR Inhibitor, In Patients With Solid Tumors (Cohort B)

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.

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.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: EKB-569
  • Drug: temsirolimus
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
42
 
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00098501
 
CDR0000398176, MAYO-MC027C, NCI-6200
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Charles Erlichman, MD Mayo Clinic
National Cancer Institute (NCI)
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP