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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
erlotinib hydrochloride
fulvestrant
Sponsored by
Translational Oncology Research International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I

Arm II

Arm Description

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

Patients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1, 15, and 29, and then every 28 days thereafter.

Outcomes

Primary Outcome Measures

Objective tumor response

Secondary Outcome Measures

Correlation of response rate with receptor expression

Full Information

First Posted
January 6, 2005
Last Updated
March 1, 2019
Sponsor
Translational Oncology Research International
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00100854
Brief Title
Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 28, 2004 (Actual)
Primary Completion Date
September 5, 2018 (Actual)
Study Completion Date
September 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Oncology Research International
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Compare objective tumor response in patients stage IIIB or IV non-small cell lung cancer treated with erlotinib hydrochloride with vs without fulvestrant. Secondary 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1, 15, and 29, and then every 28 days thereafter.
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
fulvestrant
Intervention Description
Given intramuscularly
Primary Outcome Measure Information:
Title
Objective tumor response
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Correlation of response rate with receptor expression
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Garon, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

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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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