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NCT00100854 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Translational Oncology Research International.

Completed
Registry status
Phase 2
Development phase
108
Enrollment target

NCT00100854 is a Phase 2 study that has completed, run by Translational Oncology Research International. The registered enrollment target is 108 participants.

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The verdict

NCT00100854, a Phase 2 study, has completed, sponsored by Translational Oncology Research International.

COMPLETED
Registry status
Phase 2
Development phase
108 participants
Enrollment target

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.

Interventions

  • DRUG fulvestrant
  • DRUG erlotinib hydrochloride

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2004-10-28
Est. Completion 2018-09-05
Phase Phase 2

What the Registry Record Tells You About NCT00100854

The ClinicalTrials.gov registry entry for NCT00100854 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Translational Oncology Research International, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which fulvestrant is the first listed.

NCT00100854 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00100854 about?

NCT00100854 is a clinical study titled "Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer". 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....

What is the current status of trial NCT00100854?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2004-10-28. Estimated completion is 2018-09-05.

What interventions are being tested in trial NCT00100854?

The interventions under investigation include: fulvestrant (DRUG), erlotinib hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00100854?

This trial is sponsored by Translational Oncology Research International, which has 11 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.