MedTrace Logo

Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00016367 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-10-26

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. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: Phase II trial to study effectiveness of combining cisplatin, gemcitabine, and trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Conditions

Interventions

BIOLOGICAL

Trastuzumab

Regimen A: Trastuzumab IV over 90 minutes on days 2 and 8. Regimen B: Trastuzumab IV over 30-90 minutes on days 1, 8 and 15.

DRUG

Cisplatin

Regimen A: Cisplatin IV over 2 hours on day 1 following gemcitabine. Regimen B: Cisplatin IV over 2 hours on day 1.

DRUG

Gemcitabine Hydrochloride

Regimen A: Gemcitabine IV over 30 minutes on day 1. Gemcitabine IV over 30 minutes on day 8 following Trastuzumab. Regimen B: Gemcitabine IV over 30 minutes on day 1. Gemcitabine IV over 30 minutes on day 8 following Trastuzumab.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Roy S. Herbst, MD, PhD · M.D. Anderson Cancer Center

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
1999-05-13
Primary Completion
2004-12-14
Completion
2004-12-14

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 NCT00016367 on ClinicalTrials.gov