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Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer

NCT00006015 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2013-05-03

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. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying combination chemotherapy plus trastuzumab to see how well it works in treating patients with advanced, recurrent, or metastatic colorectal cancer.

Conditions

Interventions

BIOLOGICAL

trastuzumab

4 mg/kg IV infusion Day 1, then weekly 2 mg/kg IV infusion (on Days 8, 15, \& 22)

DRUG

fluorouracil

500 mg/sq m IV push weekly for 3 weeks, followed by a 1 wk break

DRUG

leucovorin calcium

500 mg/sq m IV infusion over 2 hours weekly for 3 weeks, then a 1 wk break

DRUG

oxaliplatin

85 mg/sq m IV infusion over 2 hours Days 1 \& 15 of each cycle

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Jeffrey W. Clark, MD · Massachusetts General Hospital

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
2000-05-31
Primary Completion
2002-12-31
Completion
2003-02-28

Countries

  • United States

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 NCT00006015 on ClinicalTrials.gov