Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00100854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2019-03-05

No results posted yet for this study

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of non-small cell lung cancer cells. Hormone therapy using fulvestrant may fight non-small cell lung cancer by lowering the amount of estrogen the body makes. Giving erlotinib together with fulvestrant may kill more tumor cells. It is not yet known whether giving erlotinib together with fulvestrant is more effective than erlotinib alone in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying giving erlotinib together with fulvestrant to see how well it works compared to erlotinib alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Conditions

Interventions

DRUG

erlotinib hydrochloride

Given orally

DRUG

fulvestrant

Given intramuscularly

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Translational Oncology Research International

    lead OTHER

Principal Investigators

  • Edward Garon, MD · Jonsson Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-28
Primary Completion
2018-09-05
Completion
2018-09-05

Countries

  • United States

Study Locations

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Entities

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 NCT00100854 on ClinicalTrials.gov