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Cetuximab in Treating Patients With Advanced Solid Tumors

NCT00376727 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2010-03-29

No results posted yet for this study

Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, 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.

PURPOSE: This phase I trial is studying the side effects and best dose of cetuximab in treating patients with advanced solid tumors.

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

BIOLOGICAL

cetuximab

Dose level 0: cetuximab 400 mg/m2 week 1, 250 mg/m2 weekly; Dose level 1: cetuximab 400 mg/m2 week 1, 300 mg/m2 weekly; Dose level 2: cetuximab 400 mg/m2 week 1, 350 mg/m2 weekly; Dose level 3: cetuximab 400 mg/m2 week 1, 400 mg/m2 weekly

GENETIC

molecular diagnostic method

Tissue and Blood Specimens; IHC Methodology; IHC Scoring; K-RAS Mutation Analysis

OTHER

immunologic technique

Peripheral Blood Mononuclear Cells (PBMC)

OTHER

laboratory biomarker analysis

Cetuximab Pharmacodynamics

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Angela Davies, MD · University of California, Davis

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-11-30
Completion
2007-12-31

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 NCT00376727 on ClinicalTrials.gov