MedTrace Logo

Pemetrexed Disodium With or Without Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV or Recurrent Non-Small Cell Lung Cancer

NCT00950365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2020-09-16

Study results available
· View outcomes & findings →

Summary

This randomized phase II trial studies how well pemetrexed disodium with or without erlotinib hydrochloride works in treating patients with stage IIIB-IV or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed disodium is more effective with or without erlotinib hydrochloride in treating non-small cell lung cancer.

Conditions

  • Bronchioloalveolar Carcinoma
  • Large Cell Lung Carcinoma
  • Lung Adenocarcinoma
  • Recurrent Non-Small Cell Lung Carcinoma
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer

Interventions

DRUG

Erlotinib Hydrochloride

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Pemetrexed Disodium

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eli Lilly and Company

    collaborator INDUSTRY

  • OSI Pharmaceuticals

    collaborator INDUSTRY

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Roman Perez-Soler · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2017-11-17
Completion
2017-11-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00950365 on ClinicalTrials.gov