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CCI-779 in Treating Patients With Advanced Solid Tumors

NCT00003712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-08-09

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.

Conditions

Interventions

DRUG

temsirolimus

•Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day rest period. Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. The maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity. •Part II: Patients receive the same treatment schedule as part I. Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At least 3 patients are entered at each dose level in part II.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Texas

    collaborator OTHER

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Eric K. Rowinsky, MD · San Antonio Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2002-06-30
Completion
2002-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003712 on ClinicalTrials.gov