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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: EKB 569; Everolimus; Sirolimus

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