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

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Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00100854

Purpose
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 Intervention Phase
Lung Cancer
Drug: erlotinib hydrochloride
Drug: fulvestrant
Phase II




MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride Ici 182780
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
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


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Objective tumor response [ Designated as safety issue: No ]



Secondary Outcome Measures:
Correlation of response rate with receptor expression [ Designated as safety issue: No ]

Correlation of receptor measurements with clinical response [ Designated as safety issue: No ]

Correlation of erlotinib hydrochloride resistance with receptor expression [ Designated as safety issue: No ]


Study Start Date: October 2004
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm I: Active Comparator
Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days. Drug: erlotinib hydrochloride
Given orally
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
Given orally
Drug: fulvestrant
Given intramuscularly


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.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer

Stage IIIB or IV disease
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
Tumor tissue block must be available
No active CNS metastasis
PATIENT CHARACTERISTICS:

Age

Over 18
Performance status

ECOG 0-2
Life expectancy

Not specified
Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hepatic

Bilirubin ≤ 1.5 mg/dL
AST and ALT ≤ 2.5 times upper limit of normal (ULN)
PT and/or PTT ≤ 1.5 times ULN
Renal

Creatinine ≤ 2 mg/dL
Cardiovascular

No New York Heart Association class III or IV cardiac disease
No myocardial infarction within the past 12 months
No symptomatic ventricular arrhythmia
No symptomatic conduction abnormality
Pulmonary

No evidence of clinically active interstitial lung disease

Patients with asymptomatic chronic stable radiographic changes are eligible
Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No hypersensitivity to erlotinib hydrochloride or fulvestrant or to any of their excipients
No other comorbid disease or medical condition that would preclude study treatment or compliance
No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified
Chemotherapy

See Disease Characteristics
More than 4 weeks since prior chemotherapy
Endocrine therapy

No prior anticancer antiestrogen therapy
Concurrent stable-dose steroids allowed
Radiotherapy

More than 1 week since prior radiotherapy to non-target lesions
No concurrent radiotherapy to the lungs
Surgery

At least 7 days since prior surgery and recovered
Other

No prior anticancer epidermal growth factor receptor inhibitors
More than 4 weeks since prior non-cytotoxic investigational agents
No concurrent CYP3A4 inducers, including any of the following:

Phenytoin
Carbamazepine
Rifampin
Barbiturates
Hypericum perforatum (St. John's wort)
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100854


Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Edward Garon, MD Jonsson Comprehensive Cancer Center

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Responsible Party: Jonsson Comprehensive Cancer Center at UCLA ( Edward Garon )
Study ID Numbers: CDR0000407580, UCLA-0407058-01
Study First Received: January 6, 2005
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00100854 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer



Study placed in the following topic categories:
Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Fulvestrant
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Estrogen Antagonists
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Estrogen Receptor Modulators
Therapeutic Uses



ClinicalTrials.gov processed this record on February 10, 2009


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