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

Sponsor:	Mayo Clinic
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00098501

Purpose

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.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: EKB-569 Drug: temsirolimus	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Trial Of CCI-779 In Combination With EKB-569, An EGFR Inhibitor, In Patients With Solid Tumors (Cohort B)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: CCI 779 EKB 569

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	42
Study Start Date:	November 2004
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098501

Locations

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles Erlichman, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Rao RD, Qi Y, James CD, et al.: MCO27C: a phase I trial of CCI-779 in combination with EKB-569, and EGFR inhibitor, in patients with solid tumors. [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-165, 2007.

Study ID Numbers:	CDR0000398176, MAYO-MC027C, NCI-6200
Study First Received:	December 7, 2004
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00098501 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on November 05, 2009