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Combination Chemotherapy and Cetuximab as First-Line Therapy in Treating Patients With Advanced and/or Metastatic Colorectal Cancer

NCT00640081 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2021-09-22

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy 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 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. It is not yet known whether giving combination chemotherapy together with intermittent cetuximab is more effective than combination chemotherapy given together with continuous cetuximab in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with intermittent cetuximab to see how well it works compared to combination chemotherapy given together with continuous cetuximab as first-line therapy in treating patients with advanced or metastatic colorectal cancer.

Conditions

Interventions

BIOLOGICAL

cetuximab

DRUG

capecitabine

DRUG

fluorouracil

DRUG

leucovorin calcium

DRUG

oxaliplatin

OTHER

immunohistochemistry staining method

OTHER

laboratory biomarker analysis

Sponsors & Collaborators

  • Cheryl Pugh

    lead OTHER_GOV

Principal Investigators

  • Harpreet S. Wasan · Hammersmith Hospitals NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-06-30
Completion
2015-09-30

Countries

  • Cyprus
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00640081 on ClinicalTrials.gov