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

NCT ID: NCT00098501

Last Updated: 2013-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31

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, 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.

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. 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive oral EKB-569 on days 1-28 and oral CCI-779 on days 1-7 and 15-21.

Group Type: EXPERIMENTAL

pelitinib

Intervention Type: DRUG

temsirolimus

Intervention Type: DRUG

Given PO

Interventions

pelitinib

Intervention Type: DRUG

temsirolimus

Given PO

Intervention Type: DRUG

Other Intervention Names

EKB-569; CCI-779; cell cycle inhibitor 779; Torisel

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Erlichman

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

MC027C

Identifier Type: -

Identifier Source: secondary_id

NCI-6200

Identifier Type: -

Identifier Source: secondary_id

MAYO-MC027C

Identifier Type: -

Identifier Source: secondary_id

CDR0000398176

Identifier Type: -

Identifier Source: secondary_id

U01CA069912

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01459

Identifier Type: -

Identifier Source: org_study_id