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Everolimus, Fluorouracil, Leucovorin, Panitumumab, and Oxaliplatin in Treating Patients With Tumors That Did Not Respond to Treatment

NCT00610948 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2017-05-04

No results posted yet for this study

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving everolimus together with combination chemotherapy and/or panitumumab may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with fluorouracil, leucovorin, panitumumab, and oxaliplatin in treating patients with solid tumors that did not respond to previous treatment.

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

BIOLOGICAL

panitumumab

Given IV

DRUG

everolimus

Given orally

DRUG

fluorouracil

Given IV

DRUG

leucovorin calcium

Given IV

DRUG

oxaliplatin

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Autumn McRee, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2013-05-31
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00610948 on ClinicalTrials.gov