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

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ClinicalTrials.gov Identifier: NCT00100854
Recruitment Status : Active, not recruiting
First Posted : January 7, 2005
Last Update Posted : January 9, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Translational Oncology Research International

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: erlotinib hydrochloride Drug: fulvestrant Phase 2

Detailed Description:



  • Compare objective tumor response in patients stage IIIB or IV non-small cell lung cancer treated with erlotinib hydrochloride with vs without fulvestrant.


  • Correlate response rate with ER and EGF receptor expression in patients treated with these regimens.
  • Correlate measurement of ER-α, ER-β, EGF/HER-1 receptor and HER-2/neu receptor with clinical response in patients treated with these regimens.
  • Correlate erlotinib hydrochloride resistance with ER and HER receptor expression in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status, gender, and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days.
  • Arm II: Patients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1, 15, and 29, and then every 28 days thereafter.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 30 days and then every 2 months until disease progression.

PROJECTED ACCRUAL: A total of 102 patients (34 in arm I and 68 in arm II) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Phase II Clinical Trial of Combination Erlotinib (Tarceva®) and Fulvestrant (Faslodex®) Versus Erlotinib (Tarceva®) Alone in Advanced Non-Small Cell Lung Cancer Patients
Actual Study Start Date : October 28, 2004
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm I
Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days.
Drug: erlotinib hydrochloride
Given orally
Experimental: Arm II
Patients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1, 15, and 29, and then every 28 days thereafter.
Drug: erlotinib hydrochloride
Given orally
Drug: fulvestrant
Given intramuscularly

Primary Outcome Measures :
  1. Objective tumor response [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Correlation of response rate with receptor expression [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • adults over the age of 18 capable of giving informed consent.
  • Histologically confirmed non-small cell lung cancer
  • Stage IIIB or IV NSCLC
  • Tumor tissue block available.
  • ECOG performance status of 0, 1 or 2.
  • Measurable disease by RECIST criteria defined as ≥ 1 target lesion that has not been irradiated. New lesions that have developed in a previously irradiated field may be used as sites of measurable disease provided all other criteria are met.
  • Meets 1 of the following criteria:
  • Progressive disease after ≥ 1 prior standard chemotherapy regimen
  • Refused chemotherapy
  • Unable to receive standard chemotherapy
  • women of childbearing age must have negative pregnancy test by urine or serum prior to initiation of treatment. men and women of childbearing potential must consent to using adequate contraception throughout treatment and for 3 months following surgery.

Exclusion criteria:

  • Renal insufficiency (serum creatinine >2mg/dl)
  • Liver insufficiency (serum total bilirubin >1.5X ULN, or serum transaminases > 2.5X the ULN or %X ULN if hepatic metastases).
  • hematologic abnormality platelets< 100,000 ANC <1,500/mm3
  • THerapeutic anticoagulation will be allowed, but patients receiving fulvestrant while on therapeutic anticoagulation will have the fulvestrant dose divided into twice as many syringes to minimize the volume of intramuscular injection in these patients. In patients receiving low molecular weight heparin or fondaparinux, these medications should be held for 12 hours before and after fulvestrant injection if possible.
  • Active CNS metastases.
  • New York Heart Association class III or IV cardiac disease
  • myocardial infarction within the past 12 months
  • symptomatic ventricular arrhythmia
  • symptomatic conduction abnormality
  • evidence of clinically active interstitial lung disease
  • Patients with asymptomatic chronic stable radiographic changes are eligible
  • pregnant or nursing or inadequate contraception
  • hypersensitivity to erlotinib hydrochloride or fulvestrant or to any of their excipients
  • comorbid disease or medical condition that would preclude study treatment or compliance
  • malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • chemotherapy or non-cytotoxic investigational agents within 4 weeks of initiating treatment.
  • major surgery within 4 weeks of initiating therapy. Minor surgery within 7 days of initiating therapy.
  • anticancer antiestrogen therapy. Concurrent stable-dose steroids allowed
  • concomitant radiation therapy to the lungs. Radiation therapy to non-target lesions will be allowed as long as it is completed 1 week prior to initiation of treatment.
  • prior anticancer epidermal growth factor receptor inhibitors
  • concurrent CYP3A4 inducers, including any of the following:
  • Phenytoin
  • Carbamazepine
  • Rifampin
  • Barbiturates
  • Hypericum perforatum (St. John's wort)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100854

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Translational Oncology Research International
National Cancer Institute (NCI)
Principal Investigator: Edward Garon, MD Jonsson Comprehensive Cancer Center

Responsible Party: Translational Oncology Research International
ClinicalTrials.gov Identifier: NCT00100854     History of Changes
Other Study ID Numbers: CDR0000407580
P50CA090388 ( U.S. NIH Grant/Contract )
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2005    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by Translational Oncology Research International:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs