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

NCT00098501 | Completed Phase 1

• 6 other identifiers: NCI-2012-01459MC027CNCI-6200MAYO-MC027CCDR0000398176U01CA069912
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients

  Up to 28 days

• Number and severity of all adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0

  Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.

  Up to 30 days after last dose of study treatment

Secondary Outcomes (6)

• Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST)

  Time from the start of the treatment until disease progression/recurrence, assessed up to 3 years

• Time until any treatment related toxicity

  Up to 3 years

• Time until treatment related grade 3+ toxicity

  Up to 3 years

• Time until hematologic nadirs (white blood cells [WBC], absolute neutrophil count [ANC], platelets)

  Up to 3 years

• Time to progression

  Up to 3 years

Study Arms (1)

Arm I

EXPERIMENTAL

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

Drug: pelitinib; Drug: temsirolimus

Interventions

pelitinib DRUG

Also known as: EKB-569

Arm I

temsirolimus DRUG

Given PO

Also known as: CCI-779, cell cycle inhibitor 779, Torisel

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

EKB 569; temsirolimus; Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Charles Erlichman

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2004
• First Posted: December 8, 2004
• Study Start: October 1, 2004
• Primary Completion: October 1, 2007
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (1)