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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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. Drugs used in chemotherapy, such as CCI-779, wo...

Detailed Description

OBJECTIVES: 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. II...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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
  • Performance status - ECOG 0-2
  • At least 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin normal
  • AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver involvement)
  • Creatinine ≤ 1.5 times ULN
  • No New York Heart Association class III or IV heart disease
  • 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
  • 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
  • More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • No other concurrent chemotherapy
  • No concurrent oral contraceptives
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to \> 30% of bone marrow
  • No concurrent radiotherapy
  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    42 Patients enrolled

    Trial Details

    Trial ID

    NCT00098501

    Start Date

    October 1 2004

    Last Update

    June 4 2013

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    Mayo Clinic

    Rochester, Minnesota, United States, 55905