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

NCT00100854 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000407580P50CA090388P30CA016042UCLA-0407058-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Objective tumor response

  30 days

Secondary Outcomes (1)

• Correlation of response rate with receptor expression

  30 days

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days.

Drug: erlotinib hydrochloride

Arm II

EXPERIMENTAL

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; Drug: fulvestrant

Interventions

erlotinib hydrochloride DRUG

Given orally

Arm I; Arm II

fulvestrant DRUG

Given intramuscularly

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Translational Oncology Research International: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Fulvestrant

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Edward Garon, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2005
• First Posted: January 7, 2005
• Study Start: October 28, 2004
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-02

Locations

US (1)